The Future of Surgery and Medicine: Applied BioLogics and Adult Stem Cells
A Historical Perspective from January 28, 1953 to January 28, 2008
The Stowe Foundation was incorporated by Dr. Lawrence R. Stowe in April of 2003 as a Texas non-profit medical research organization to honor the memory of his mother, Edith Stowe. Dr. Stowe’s mother had shown great strength and courage in her personal victory over pancreatic cancer using Applied BioLogics, the Foundation’s signature concept of comprehensive immune therapy. The Stowe Foundation was established to gain medical acceptance and regulatory approval for the experimental technology that saved and prolonged her life. The Stowe Foundation is also to honor Edith Stowe for the wisdom and spiritual guidance she provided in 1959 to help her son survive his own battle with osteosarcoma (a fatal form of bone cancer) when he was 6 years old. The Stowe Foundation is really the story of a mother and son and their journey through life. Both survived fatal forms of cancer and lived to tell their story. The Stowe Foundation is dedicated to bringing these survival techniques into mainstream medicine and guiding healthcare into the new era of human cell therapy and biological medicine, the future of surgery and medicine.
In December of 1999 at the age of 80, Edith Stowe had been diagnosed with inoperable pancreatic cancer. Her life expectancy was a short two months. At the time of her diagnosis, Dr. Lawrence Stowe was working in Atlanta, GA as the managing director of the non-profit medical research foundation, Survive Until A Cure (SUAC). Dr Stowe had co-founded Survive Until A Cure in 1995 with his personal friend and business associate Scott Broder to promote comprehensive immune therapy as a method to survive life threatening medical issues such as cancer and AIDS. Survive Until a Cure had drawn its inspiration from Dr. Stowe’s personal battle with cancer and from the experience Dr. Stowe had in 1988 with True Health and the fight against the AIDS epidemic.
Dr. Stowe was called home to Davenport, Iowa by his sister, Myra, in January of 2000 to apply these investigational techniques against their mother’s newly diagnosed pancreatic cancer. By utilizing an experimental cancer vaccine manufactured by Dr. Nikolaus Klehr in Germany and the concepts of Nutritional BioTherapy developed by Dr. Stowe in 1988 for AIDS patients, plus the biologic response modifiers supplied by Dr Ivan Danhof to induce cytokine therapy, Dr Stowe assisted his mother’s oncology team to maneuver the pancreatic cancer into a long term remission.
Edith Stowe survived nearly 3 years beyond her 2 month terminal prognosis given in 1999 and led a very high quality of life. Edith died of natural causes in August of 2002. She was 83 years old and cancer free at the time of her death. The Stowe Foundation is dedicated to her memory and the hope that some day all families might benefit from comprehensive immune therapy, the technology that saved her life.
While others can benefit from the same biological techniques that put Edith Stowe’s pancreatic cancer into remission, the therapies are all considered experimental and investigational under the rules and regulations of the FDA. Hence Dr. Stowe felt the need to establish The Stowe Foundation and raise the capital to carry out the regulatory work that would permit immune therapy to enter mainstream medicine and clinical practice in the United States. The Stowe Foundation elects to call comprehensive immune therapy, Applied BioLogics. The term stands for; the logical application of biological medicines, human cell therapy and biologically active medical devices to promote the body’s natural ability to heal itself through the immune system.
Dr Stowe himself survived a battle with osteosarcoma (bone cancer) in 1959 when he was six years old and it was a series of medical anomalies that triggered a “spontaneous remission” of this normally fatal version of cancer. Dr Stowe’s personal encounter with cancer was the genesis of the Survive Until A Cure Foundation. Dr Stowe’s terminal prognosis was four years. He was to be dead by the age of ten from the metastasis of the cancer. Dr. Stowe is 55 years old at the time of this memorandum. Survival should be the first goal of all terminal cancer patients. Dr. Stowe and his mother Edith Stowe both survived very fatal forms of cancer using the techniques of Applied BioLogics.
The medical anomalies that occurred in 1959 with Dr. Stowe and his osteosarcoma are now recognized in 2008 to be whole body hyperthermia (an artificial fever), the activation of T-cells and Natural Killer Cells through antigen and cytokine provocation (dendritic cell therapy), plus Nutritional BioTherapy (biologic response modifiers) coupled with control of the biologically active energy fields associated with cellular performance (energy medicine). The medical mysteries of 1959 now form the basis of the modern technology of immune therapy.
In more simple terms, Dr. Stowe developed a very high fever in 1959 from a bacterial infection of the dead skin and the charred muscle and fat tissue that resulted from the massive radiation treatments used to treat the bone cancer. Fever is now recognized to be a trigger mechanism to the release of cytokines by the immune system. Edith Stowe then used an investigational veterinary procedure from the University of Minnesota, Immune Milk, to create a targeted immune response to the cancer cells. Dr. Stowe’s mother also placed him on a diet filled with fresh fruits and vegetables from her organic garden. Dr. Stowe’s full recovery from osteosarcoma is still considered a medical miracle.
However, the medical miracle in 1959 can now be analyzed through the modern understanding of immune therapy. In terms of the cell mediated response of the immune system, the dead cancer cells created by the radiation presented numerous antigens of the tumor to the immune system’s dendritic cells and macrophages, which passed the information on to the T-Cells of the immune system, which had been systematically activated by a bacterial infection. The pyrogenic bacterial infection of the over-radiated and necrotic skin of the lower right leg, an unplanned and fortuitous event, caused a high fever response, which resulted in heat shock proteins being released into the system. The heat shock proteins in turn carried even more of the cancer antigens into the dendritic cells and caused more T-Cells to actually recognize the cancer. The cell to cell communication between the T-Cells and the dendritic cells is accomplished through cytokines naturally released by the activated immune cells. Dr Stowe’s diet, which was fortified with the anti-oxidants and trace minerals from the fresh fruits and vegetables of his mother’s organic garden, provided strong nutritional support to the immune system. Edith Stowe had also commissioned a local diary farmer to produce an experimental colostrum called Immune Milk, which we now know contains transfer factors that activate the natural killer cells of the immune system. It was a fortunate series of events, but it is a script that can be followed by every cancer patient in their attempt to survive the cancer process.
The massive radiation treatments used to kill the cancer cells left Dr. Stowe with a deformed and very weak right leg void of muscle mass and fat and lacking in normal circulation. However, this was deemed an acceptable alternative to the proposed amputation of the right leg at the hip. The leg was later amputated below the knee in 1998 at age 36. During the intervening thirty years, Dr Stowe was able to participate in high school athletics, college intramurals and church softball. The word handicapped came with such negative connotations that Edith Stowe never allowed the term to be used in reference to Dr. Stowe’s physical condition.
Edith Stowe never permitted the toxic negative emotions of fear, anxiety or anger to control her son’s life. Instead she taught her son to seek spiritual comfort in his Christian upbringing and to trust the answers that come from prayer. The senior pastor at First Christian Church in Davenport, Iowa, in 1959 was Tom Waters. Tom worked with the young Dr. Stowe during his adolescent years to develop a strong spirit filled life. It was Tom Waters that taught Dr. Stowe to confront the pain of recovery with prayer for courage and endurance. We did not pray that that the pain would miraculously disappear, we prayed for the courage to endure the painful rehab process. Suffering gives way to endurance. Endurance leads to Perseverance. Perseverance leads to Hope. Hope leads to Recovery. Staying the course in the face of pain and suffering requires prayer. I imagine it is the same type of pathway that allowed John McCain to survive the POW camps of Vietnam.
It was also Tom Waters that taught Dr. Stowe to ignore the taunts of his childhood friends about his physical deformities. The right leg was really deformed by the intense radiation. In reality, those taunts were the other children’s spiritual problem. The lack of compassion was their sin. The process of prayer for his “bully classmates” taught Dr. Stowe the meaning of forgiveness. We now know that those who are in communication with the heavenly father can better deal with the stress of life, can deal with the emotional traumas of life, can deal with physical pain. It is prayer that can bring balance to the mind, body, spirit and emotions. Our faith is the belief in the Creator, prayer is how we talk and listen to the Creator. Prayer is important to all faiths and all religions. It is an important part of immune therapy and self healing through the immune system.
It was prayer that guided Edith Stowe’s personal decision to commission a local dairy farmer to produce what is called Immune Milk from a “springing heifer”. This technology is fully covered in the paper entitled Universal Oral Vaccine: The Immune Milk Saga, which is posted on the Stowe Foundation website at www.thestowefoundation.org. The article was copyrighted in 1998 by the Roger Wyburn-Mason and Jack M Blount Foundation for Eradication of Rheumatoid Disease aka, The Arthritis Trust of America, www.arthritistrust.org. However, Immune Milk was first utilized in the 1950’s to treat diseases with immune therapy and stemmed from veterinary research being conducted at the University of Minnesota. Edith Stowe chose her son Lawrence to be a human test case.
The doctors had given a terminal prognosis to her son and this was just not acceptable to Edith, a strong willed Midwestern mother. In America, where freedom is still strong, families should have the right to choose investigational therapy. It saved Dr. Stowe’s life at a very early age. Investigational therapy saved Edith Stowe’s life at a very late age. The goal of The Stowe Foundation is to move immune therapy into mainstream medicine so that the technology can save many lives.
Like many natural products that come from the field of bio-technology, Immune Milk has a long and storied history with the FDA. Immune Milk is the predecessor technology to the pharmaceutical industry’s interest in transfer factors. The conflict is not about scientific truth, it is about who is going to control the financial return on the investment. The financial return can go to the dairy farmers who can produce the Immune Milk or the pharmaceutical company who can produce synthetic transfer factors. The rules and regulations of the FDA clearly favor the pharmaceutical industry, which may not be in the public’s best interest. The story of transfer factors is told on The Stowe Foundation website.
At the time of Dr. Stowe’s battle with Osteosarcoma, the result of immune therapy was simply called a miracle and a “spontaneous remission”. We now call it nutritional biotherapy, whole body hyperthermia, dendritic cell therapy, cancer vaccines, cytokine therapy and T-cell activation and natural killer cell therapy with biologic response modifiers. Comprehensive immune therapy comes from managing the cell mediated response of the immune system. Unfortunately, modern medicine and the FDA still require you to test the therapies one treatment at a time. Taken one at a time, the individual therapies fail to deliver a remission of cancer and hence are not permitted to reach the market. That is certainly not in the best interest of the public health care system.
Dr Stowe was fortunate that all the therapies occurred naturally and simultaneously and that he survived his terminal prognosis through a “spontaneous remission”. The spontaneous remission of Dr. Stowe’s osteosarcoma of 1959 being greatly assisted by Dr. Stowe’s immune system and the Immune Milk. Unfortunately, Dr. Stowe’s own remission of osteosarcoma and that of his mother’s pancreatic cancer can not be tested or explained through the modern medical philosophy of allopathic medicine. The constructs of allopathic medicine require that every disease has a single cause, like a bacterial infection, and that every disease can be treated with a drug or an intervention, like an antibiotic and surgery. The drugs for killing cancer cells are called chemotherapy and the medical energy devices are called radiation therapy. Most US citizens and scientists would agree that the war on cancer has been a miserable failure following this approach. Modern oncology treats tumors and existing cancer cells; it does not treat the cancer process. Hence many cancers recur years after the patient has been declared cured. Treating tumors does not stop the cancer process, unless the therapy is fortunate to get it all. It is a functional immune system that can stop the cancer process. Immune therapy needs to become an integral part of all cancer therapy.
Unfortunately, every chronic illness, not just cancer, has defied the allopathic approach to medicine and hence heart disease, cancer, arthritis, diabetes, emphysema, chronic bronchitis, lupus, fibromyalgia, MS, ALS, Parkinson, Crohns, Celiac, Alzheimer’s and stroke all have national foundations trying to find a cure. The support organizations, like the American Cancer Society, pound the drum beat of allopathic medicine and pharmaceutical drugs and yet no cures have been found. When you read the Stowe Foundation’s white paper on Applied BioLogics and Inflammation you will realize that all of the national organizations are seeking the same thing, an end to disorders of the immune system. This is probably best described in the paper entitled; Nanobacteria Link to Cancer and Heart Disease, which is also posted on the Stowe Foundation website. It is hard for the medical profession to accept the concept that all chronic illness might be exactly the same disease. At the Stowe Foundation we call it the PITTS Syndrome [Poor Nutrition, Infections, Toxins, Trauma and Stress] and Applied BioLogics is used to reverse the PITTS Syndrome.
What the American public, professional scientists and physicians, plus our regulatory agencies need to recognize is that allopathic medicine has no relationship to how the human body actually heals itself. Allopathic medicine is based on intervention in the disease process by surgery or medication. The surgical procedures and drugs rescue the body from the attack; they do not heal the body. Even after a successful intervention the body must still heal itself from the damage. The body’s natural ability to heal itself comes from the immune system. Immune therapy supports the immune system and Applied BioLogics is the Stowe Foundations signature method of supplying immune therapy. Applied BioLogics is simply a very scientifically advanced form of immune therapy. The science has been evolving since the early 1950’s.
At Mobil Oil Research and Development, where Dr. Stowe was a senior research engineer early in his professional carrier, they referred to the blind adherence to a defective scientific theory as the fatal flaw of research. The modern concept of the placebo controlled double blind study, the gold standard of allopathic medicine, is a major impediment to creating human cell therapies that reflect the true nature of the human immune system. A placebo controlled double blind study can only test the efficacy of a single active ingredient. That is not how the human immune system works.
There are no magic bullets and there are no single active ingredients when it comes to the human immune system. The human immune system is a very complex set of biologically active and interactive feedback loops. It takes a multi-factorial approach to generate a healing response. Today’s magic bullet to chronic illness is being advertised as adult stem cells and embryonic stem cells. Unfortunately, the simple transplant of stem cells into damaged tissue is only going to generate a transient repair. There are no magic bullets. It takes the full armory of Applied BioLogics to reverse a chronic and sometimes life threatening illness. Stem cells play a critical role in tissue repair and regeneration of healthy organs, but they are not a panacea. Stem cells do not cure a disease. That takes comprehensive immune therapy.
The Stowe Foundation has created a comprehensive approach to immune therapy. We call it Applied BioLogics. It has evolved over the past 60 years of research and development of the individual biological medicines, the individual human cell therapies, the individual biologic response modifiers, the individual biologically active medical devices, the individual autologous blood products, and the individual whole food supplements used in Nutritional BioTherapy. The Stowe Foundation under the guidance of Dr. Stowe, the managing director of the Foundation, integrates the diverse technologies of Applied BioLogics into comprehensive immune therapy. Applied BioLogics is the intellectual property of The Stowe Foundation.
It really takes a team of biomedical engineers, electrical engineers, biomolecular engineers, chemical and mechanical engineers plus physicists and botanists trained in system analysis and process control to devise a comprehensive immune therapy protocol. That team of engineers and scientists are now called the research associates of The Stowe Foundation. The Stowe Foundation of 2008 is a very unique organization where the knowledge of the immune system can be synthesized into comprehensive immune therapy and Regenerative Medicine. We have been setting the stage over the past twenty years for the transformation of medicine into the biological era of human cell therapy.
MD’s are trained in the pharmaceutical model of medicine. That philosophy has many scientific flaws in understanding the complexities of the immune system. The FDA’s regulations are flawed in the same way. One of the primary missions of the Stowe Foundation is to educate both professionals and layman in the constructs of immune therapy. That will allow the government to do its regulatory work and the citizens to receive the benefits of Applied BioLogics. But primarily, it will free our scientists from a flawed and seriously defective approach to healing. The philosophy of allopathic medicine is antiquated and has run its course. It should no longer be the driving force behind our regulatory environment. The Stowe Foundation is dedicated to moving our understanding of the human immune system into mainstream clinical practice and to escort the technology platform and intellectual property through the regulatory maze known as the FDA.
Medicine must be allowed to enter the modern world of quantum physics, nanotechnology, human cell therapy and biotechnology. The transformation is seriously inhibited by the antiquated medical philosophy of allopathic medicine and the regulatory environment that surrounds the practice of medicine. The enormous profits that surround the philosophy of allopathic medicine make a fundamental change to immune therapy a very large uphill battle. Money and profits will trump science and truth every time. Hence, another challenge for the Stowe Foundation is to create a profit incentive that will attract the capital required to transform medicine and level the playing field. The profit incentive has become the business plan known as Stowe BioTherapy/Trinity BioLogics. Stowe BioTherapy holds an exclusive license to commercialize and profit from the Intellectual Property (IP) of The Stowe Foundation as it relates to comprehensive immune therapy and adult stem cells. In return, the Stowe BioTherapy/Trinity BioLogics project provides royalties to The Stowe Foundation to further its mission statement. It is a private-public partnership.
Comprehensive immune therapy, the IP of The Stowe Foundation, is the ability to trigger an immune response on demand and by design. That is what leads to a “spontaneous remission” of any chronic illness. When Dr. Stowe was a child in 1959 it was a miracle and a fortunate series of events that lead to the remission of his osteosarcoma. When Dr. Stowe’s mother was 80 years old in 1999, the remission of her pancreatic cancer was by intelligent design. The purpose of The Stowe Foundation is to engineer spontaneous remissions of chronic illness. Applied BioLogics and Regenerative Medicine with adult stem cells are the tools of the trade.
Unfortunately in 2008, both osteosarcoma and pancreatic cancer are still considered to be two of the more deadly forms of cancer and still must be treated by chemotherapy, radiation and surgery. Those are the gold standards of care for cancer as stated by the American Medical Association (AMA) and any doctor that suggests there may be alternatives to the Gold Standard faces an ethics challenge investigation by the Medical Examiners office of the state where the MD maintains his license. The Stowe family thinks that is a poor way to treat the American public and Dr. Stowe has dedicated the last twenty years of his professional career and personal financial resources to making changes.
The Stowe Foundation was established to raise the money it will take to perfect the technology of immune therapy and adult stem cells and to cross the numerous regulatory hurdles of the FDA and make the therapies of Applied BioLogics readily available to the American Public. After 21 months of review by the IRS, from April of 2003 to January of 2005, The Stowe Foundation had its status as a private medical research foundation elevated to the status of a Public Charity. In January of 2005, the IRS determined that the work of The Stowe Foundation was being done in the public interest and enjoyed broad public support. The IRS has certified The Stowe Foundation to be a national Public Charity. We are now looking for the financial resources to carry out our mission, just like the United Way, the American Red Cross, Habitat for Humanity and other Public Charities seek financial contributions.
The primary mission of The Stowe Foundation is to make Regenerative Medicine with adult stem cells and Applied BioLogics, a form of comprehensive immune therapy, a clinical reality. Many of the investigational techniques, known as Applied BioLogics, are approved medications and medical devices outside the borders of the United States. Others are under intense investigation in the foreign national and federal medical systems that are more responsive and favorable to biological medicine then the FDA. The Stowe Foundation is also working with the physicians, scientists and inventors of the biological medicines, the biologically active medical devices and the human cell therapy products to help meet the US standards of care and to gain regulatory approval from the FDA.
The Stowe Foundation has close alliances with private companies such as Harvest Technology in Massachusetts, Chisolm Biological Laboratory in South Carolina, and the Institute for Cellular Medicine in Mexico and we support academic research scientists at major Universities such as Dr. Ewa Carrier at the University of California San Diego, Dr. Luther Lindner at Texas A&M University and Dr. Lisa Fortier at Cornell. We also have a strong relationship with the Minister of Health in Mexico through Dr. Carlos Fink Serralde and Anahuac University and Dr. Frank Morales at the Poly-technical Institute in Mexico City. The Foundation also supports the work of our research associates, Dr. Peter Lathrop and Dr. David Stokesbary. Dr Lathrop and Dr. Stokesbary are experts in energy medicine. Each scientist provides a key piece of the puzzle, but it is only at The Stowe Foundation where the pieces are assembled into a comprehensive and integrated solution. For example, Dr. Nabil Dib, www.cardiostem.com a US and international authority on stem cell therapy will guide the regulatory approval process of Regenerative Medicine. Dr Dib desires to find a cure for heart disease, not a temporary stem cell fix that elevates heart function for relatively short periods of time.
The science and medical hypothesis of Applied BioLogics is presented on The Stowe Foundation website. These techniques can be accessed under medical supervision at Stowe BioTherapy in San Diego, CA. Stowe BioTherapy is a Center for Regenerative Medicine built by the Stowe Foundation to supply comprehensive immune therapy in the form of highly personalized and custom compounded biological medicines coupled with the regenerative powers of adult stem cells. Stowe BioTherapy holds an exclusive technology license to the commercial applications of The Stowe Foundation’s technology platform. The Stowe Foundation is taking Stowe BioTherapy onto the financial markets to raise the capital it will take to level the playing field between comprehensive immune therapy and allopathic medicine. Stowe BioTherapy/Trinity BioLogics is a chance for profit minded investors to support the transformation of surgery and medicine into a new era of adult stem cells and personalized immune therapy, the future of surgery and medicine.
Dr. Stowe has been investigating comprehensive immune therapy since 1988, when he left Mobil Oil Research and Development to assist a Dallas, TX based nutritional company, True Health, in the fight against AIDS. Dr. Stowe’s educational background as a dual PhD in Chemical Engineering and Biomolecular Engineering from the University of Illinois (1982), combined with two master degrees from Iowa State University (1978), one in Chemical Engineering and one in Biomedical Engineering, and a BS degree in Chemical Engineering from Iowa State (1975), gives Dr. Stowe a unique perspective on how the molecular reactions of the immune system actually occur in the human body under the influence of enzymatic reactions and biologically active energy fields. There is a reason that the human body can operate at the phenomenally low temperature of 98.6 degrees Fahrenheit, while an oil refinery requires in excess of 1,000 degrees Fahrenheit. Enzymes are the world’s perfect catalyst for lowering the activation energy of the biochemical reactions needed to support life. It is the micro-environment of the cells that controls the activity of the enzymes. Applied BioLogics is all about regulating the micro-environment of the cells. The health of the human body is controlled by the health of the cells. That includes the cell mediated response of the immune system. Human cell therapy is required to reverse a chronic illness.
Over the last 20 years, Dr. Stowe has dedicated his time, energy and financial resources to the creation and implementation of the medical devices required to manipulate the biologically active energy fields of the human immune system, the biological response modifiers (herb, plant and food extracts) that can control or modulate the immune response and the antigen vaccines that can target the immune response. During this time of exponential growth in knowledge about the immune system, it has also been discovered that the bone marrow produces a large reservoir of cells that can be used in human cell therapy. Dr. Stowe has integrated the knowledge base of The Stowe Foundation into Applied BioLogics for comprehensive immune therapy and adult stem cells for Regenerative Medicine.
Human cell therapy is the key to Regenerative Medicine. Chronic inflammation, the hallmark and signature concept behind every chronic illness, destroys a lot of healthy tissue. Human cell therapy is required to regenerate healthy new tissue. The other option is to undergo an organ transplant or joint replacement surgery. For human cell therapy to be a permanent fix to the degeneration of the body, it is imperative that we stop chronic inflammation. The Stowe Foundation refers to chronic inflammation as the PITTS Syndrome. Applied BioLogics or comprehensive immune therapy reverses the PITTS Syndrome. The white paper titled “Applied Biologics and Inflammation” can be read on The Stowe Foundation website.
Over the years, it has become apparent that the heart and soul of the immune system is contained in the bone marrow and is characterized by the hematopoietic stem cells generated by the bone marrow. There is further evidence that the hematopoietic stem cells are themselves produced by a pluripotent adult stem cell. The Stowe Foundation refers to this cell as the Universal Pluripotent Stem Cell or the UPS cell. The UPS cell will play a major role in Regenerative Medicine and what the FDA calls human cell therapy. Human cell therapy, biological agents and vaccines are all regulated by the FDA’s Center for Biologics Evaluation and Research (CBER). CBER also regulates the biomedical energy devices that are based on electromagnetic, photodynamic, heat and acoustic energy. A wide variety of energy spectrums can influence biological activity. The Stowe Foundation’s activities in the area of immune therapy are all regulated by CBER and have evolved into the trademark concept of Applied BioLogics and Regenerative Medicine.
Dr. Stowe’s original work with True Health in 1988 was focused on Nutritional BioTherapy (proteins, fats, carbohydrates & sugars) and Biological Response Modifiers (Aloe Vera, medicinal grade mushrooms, Chinese herbs, etc) to promote the natural killer cells (NK cells) of the immune system to respond to and attack the virally infected T-cells of the AIDS patient. That is the role of NK cells, to destroy abnormal tissue and pathogens. Once the abnormal T-cells were eliminated, the bone marrow and lymphatic tissue could produce healthy robust T-cells and the immune system would be restored to fully functional levels. AIDS is an acronym for Acquired Immune Deficiency Syndrome. The goal of the True Health protocol was to reestablish a healthy robust immune system to correct the immune deficiency. It was not intended to be a cure for AIDS. The True Health protocol was intended to restore a healthy robust immune system in the face of the HIV virus. That would allow the AIDS patient to survive until a cure could be created. True Health would turn AIDS into a manageable disease.
Dr. Stowe’s immune therapy concepts were first applied in a controlled clinical trial with 30 AIDS patients in 1989. Dr. Terry Pulse, the principal investigator, published this landmark study in 1990 in the Journal of Advancement in Medicine Volume 3, Number 4. The clinical trial clearly demonstrated that a devastated immune system could be rebuilt and functionally restored using nutritional supplements and biologic response modifiers. This was the first demonstration of natural killer cell therapy. It is based on biological medicine and the cell mediated response of the immune system. The results of the study were unequivocal. AIDS patients can have a robust immune system.
Unfortunately the clinical trial with True Health occurred 10 years before the FDA had the Center for Biologics Evaluation and Research, CBER. There was simply no regulatory mechanism to get marketing approval for a series of biological medicines, unless you went through the drug approval process, which was well beyond the financial capacity of True Health. The interactions between True Health and the FDA are well documented in a book titled Innocent Casualties. This book and the regulatory battles surrounding True Health played a prominent role in Congress mandating, and President Clinton signing into law, the FDA reform act of 1997. The FDA then opened CBER in 1998. It took overwhelming political and public pressure to force a change in the political and financial infrastructure that governs the practice of medicine. The job is far from over.
Unfortunately, it took another 9 years for CBER to be adequately staffed and to start to issue industry guidelines on biological medicines. For example, the CBER document, Guidance for Industry Report: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, was not issued until May of 2007. That is a full 18 years after the first clinical trials of natural killer cell therapy were sponsored by True Health in 1989. Without these guidelines, manufactures of biological agents have lacked a mechanism for gaining regulatory approval of biological medicines in the treatment of cancer and other disease states. Hence the biological medicines have not penetrated the US market despite overwhelming use in the European and Asian Markets. In the United States, the biological agents have been restricted to a handful of academic studies and US physicians have actually been prosecuted for using them in their clinical practice. Albarin, an extract from the Aloe Vera plant, is a classic modern example of the conflict between regulations and science.
The biologic response modifiers used in the True Health proof of concept clinical trials with AIDS patients included extracts from the aloe vera plant known as polysaccharides. The polysaccharides from the aloe vera plant have the biological effect of stimulating the macrophages and the dendritic cells of the immune system to release cytokines. The cytokines are the chemical messengers of the immune system and can help attract natural killer cells and T-cells to the area of the body where there is infected tissue or abnormal cells such as cancer cells. Macrophages and dendritic cells only release cytokines when they have digested an invading pathogen, detected an abnormal tissue or malfunctioning cell, or are in the process of cleaning up the body from dead tissue. Macrophages and their cousins the dendritic cells help sound the alarm. Macrophages and dendritic cells help the immune system to "see" dangerous microorganisms and tumor cells and assist in their destruction.
The long chain polysaccharides of the aloe vera plant have direct immune enhancing and modulating properties. These properties include increasing immune cell production and stimulating and improving white blood cell activity. Aloe thus provides excellent nutritional support for an optimum functioning immune system. However, when tested as a stand alone therapy, as required by the FDA under drug standards, Aloe Vera does not significantly attack AIDS. The Aloe Vera products utilized by True Health were supplied by Carrington Labs, a company who spent several million dollars in the 1980’s trying to get Acemannan, a purified Aloe Vera extract, classified as a pharmaceutical drug. While Aloe Vera is a powerful immune modulator it is not a drug in the classic sense.
Dr. Ivan Danhof, the medical director of Carrington Labs in Dallas, TX during the True Health study, took the concept of aloe vera extracts even further by developing Albarin in the late 1990s. Both Albarin and Acemannan have a long and storied history with the FDA and have been relegated to the practice of alternative and complementary medicine. The Stowe Foundation hopes to resurrect the prospects of testing Albarin under the new guidelines of CBER posted as of May 2007. The science is clearly on the side of the aloe vera plant being a powerful biologic response modifier. Aloe Vera extracts were part of the comprehensive immune therapy program created by Dr. Stowe to assist his mother and her fight against pancreatic cancer. The aloe vera extracts were provided as a nutritional supplement under the FDA’s revised labeling laws regarding structure and function claims of health products.
The original True Health study also incorporated fish oil and evening primrose oil as sources of the essential fatty acids gamma linolenic acid (GLA) and eicosapentaenoic acid (EPA). What are essential fatty acids (EFA’s)? The EFA’s are fats that are essential for life. Research in the 1980’s by firms like Efamol in Canada headed by Dr. David Horrobin, a pioneer in fatty acid research, confirmed that fat comes in good and bad forms, and too much bad fat in your diet (the trans fatty acids) can contribute to obesity. However, too little fat can also be very bad for you, particularly if you're very young - and too little of the vital Long Chain Polyunsaturated Fatty Acids (LCPUFA) could contribute to a variety of health issues:
- Reduced learning ability
- Slower development
- Hormonal imbalance
- Dry skin
- Inflammatory diseases.
Dr. Horrobin’s work showed that there are two 'families' of essential fatty acids (EFA’s), the omega-6 and omega-3 series, the 'parents' of which are an essential component of a healthy diet as the parent fats cannot be produced by our bodies:
- Linoleic acid (LA) is the parent fatty acid of the omega-6 family and is commonly found in vegetable oils such as corn oil, sunflower oil, palm oil, rapeseed oil and soy oil. Evening Primrose Oil (EPO) is a member of the omega-6 family.
- Alpha-linolenic acid (ALA) is the parent of the omega-3 family and predominantly comes from green leafy vegetables and some vegetable oils (flax, rape and soy), while the longer chain members of the omega-3 series is predominantly found in fish and fish oils.
These essential parent fats are converted in the body by enzymes into Long Chain Polyunsaturated Fatty Acids (LCPUFA). The four most important LCPUFA’s needed by the human body are:
- Gamma Linolenic Acid (GLA) - An important omega-6 nutrient needed for important bodily functions such as the maintenance of hormonal balance and healthy skin structure. Can also be broken down into arachidonic acid (AA).
- Arachidonic Acid (AA) - An important omega-6 nutrient found in the membranes of nerves and helps with the transmission of messages in the central nervous system.
- Docosahexaenoic Acid (DHA) - An important omega-3 nutrient needed by the body for the structure of nerves and cells and is needed for brain and eye health in particular.
- Eicosapentaenoic Acid (EPA) - An important omega-3 nutrient needed by the body for the role it plays in maintaining healthy and supple joints, circulation and heart health.
Unfortunately, the body's enzymatic conversion of essential fatty acids to long chain polyunsaturated fatty acids is an inefficient process, especially in the very young and old and during times of stress or illness. However, the biggest contributing factor towards a long chain deficiency is the modern lifestyle and diet:
- High consumption of alcohol, caffeine, saturated fats, sugar, nicotine, and excess cholesterol can affect the efficiency of enzymes and therefore inhibit the manufacture of long chain polyunsaturated fatty acids in the body.
- An increase in vegetable oil consumption has resulted in excess omega-6 fatty acids in the diet
- An increase in vegetarianism has resulted in an excess of omega-6 fatty acids, while strict vegetarian diets provide no DHA, EPA or AA
- Increases in hydrogenated fats in processed foods has increased trans fatty acid consumption
- Low fish consumption leads to low intakes of the vital DHA and EPA
- Farmed fish and meat from cattle fattened on cereals rather than grass have less omega-3 long chain polyunsaturated fats than before
- Over the years, breast milk composition has changed and mother's milk now has less DHA and more omega-6 fatty acids
The impaired conversion of the “parent” essential fatty acids contained in the diet means their long chain polyunsaturated fatty acid derivatives GLA, EPA, DHA and AA need to be supplied pre-formed in the diet through supplements, and many years of research have pointed to Evening Primrose Oil as the most reliable source of GLA. Fish oil from oily fish such as tuna, mackerel, and salmon are a rich source of EPA and DHA.
The long chain polyunsaturated fatty acids are also the immediate metabolic precursors to hormone like substances known as prostaglandins. Research in the 1980’s by a very large number of universities, foundations and drug companies discovered that prostaglandins played a major role in many biological processes. One of the more important properties of prostaglandins was the ability of prostaglandins to control and modulate the inflammatory response of the immune system.
Since that time, Fish Oil has been recognized as a major biological response modifier in the fight against heart disease. Evening Primrose Oil has been studied in the fight against cancer. Chronic inflammation is present in nearly all chronic illness and auto-immune disorders. It is a key aspect in AIDS and Cancer. In 1988, Dr. Stowe felt that the human immune system could receive a major boost by supplementing the diet of AIDS patients with the long chain polyunsaturated fatty acids, GLA, EPA, DHA and AA. This was accomplished by supplying the AIDS patients with large doses of Evening Primrose Oil and Fish Oil. Efamol Labs provided the blended capsules of EFA’s in support of the clinical investigations of Nutritional BioTherapy.
What impeded progress in testing the EPO in 1988 was getting the FDA to lift an import alert they had placed on Evening Primrose Oil as being unfit for human consumption, even though it had GRAS status (Generally Regarded as Safe). That is detailed in the book Innocent Casualties. The first obstacle True Health had to overcome was getting a nutritional supplement with GRAS status into the country. The American public seldom hears the full story about how the FDA protects the financial interests of the pharmaceutical industry. The book Innocent Casualties details this phenomenon in great detail.
When used therapeutically, the hidden problem with EFA’s is that the parent EFA’s and their metabolites of GLA, EPA, DHA and AA are easily oxidized by the singlet oxygen produced during the production of cellular energy by the Krebs cycle within the mitochondria. The free radical cascade of life sustaining cellular respiration can end up with the EFA’s being converted to lipid peroxides, which are very toxic to cellular health. Hence it is critical for the anti-oxidant system of the cells to be operating at peak efficiency in order to control free radical pathology and to insure proper EFA metabolism. Hence the therapeutic benefits of the EFA’s are dependent on controlling free radical pathology.
Human cells utilize a complex anti-oxidant system to regulate free radical pathology. In human tissues, free radicals are highly reactive molecules that are indiscriminate in their bonding to other molecules. Free radicals can mutate DNA, disrupt cell membrane integrity and disrupt cell membrane electrical potential along with changing the cell membrane wall permeability and the free radicals can promote uncontrolled cell division by interfering with the normal biologic controls of the cells metabolism. Hence singlet oxygen, created during cellular respiration, is an important promoter of the free radical cascade and an abnormal or malignant cell may result from oxidative stress to the cell. Because of this, free radical pathology is intimately linked to proper EFA metabolism. This is a classic sample of one biologic system, EFA metabolism, being influenced by another, cellular respiration.
Cellular respiration can only be understood by quantum mechanics and the description of atomic particles. A normal oxygen atom has four pairs of electrons. The body’s natural metabolism, using enzymes as the catalyst, can remove one electron from oxygen’s outer valence pair. The term singlet oxygen was coined to describe an oxygen atom that has lost one electron. The singlet oxygen is now a free radical, which tries to balance its electronic state by raiding an electron from a nearby molecule. The layman’s term is oxidative stress.
If the singlet oxygen takes an electron from a molecule in a cell wall, a new hydrocarbon based free radical is created. Hydrocarbon based free radical chemistry is the controlling technology behind every oil refinery in the world. Hence chemical engineers are highly trained in hydrocarbon based free radical technology as are biomolecular engineers and the cell biologists who study free radical pathology within human metabolism. The physical structure of the cell wall is altered by the presence of the free radical hydrocarbon. This can trigger a cascade of molecular events where the new molecule steals an electron from a neighbor. The chain of electron theft slowly erodes the integrity of the cell membrane wall and slowly opens the door to loss of cell function. Accumulate enough abnormal cells in the tissue, gland or organ and the organ loses function. Free radical pathology is the fuel to the fire of cellular degeneration. Lose enough cells and you have a disease.
Modern medicine defines the disease by where you have lost the cells. Lose enough cells in the brain that produce dopamine and you have Parkinson’s. Lose enough cells in the pancreas that produce insulin and you have type II diabetes. If the body loses the ability to regenerate the myelin sheath of the nerves you have MS. Free radical pathology plays a role in every chronic illness that modern medicine deems incurable. Because of the complexity of free radical pathology, there will never be an allopathic or pharmaceutical cure for chronic illness.
At best pharmaceutical drugs can treat the symptoms of uncontrolled free radicals. Symptomatic relieve and control medications are the blockbuster medications of the 20th century. Insulin does not cure diabetes. Anti-inflammatories do not cure arthritis. Calcium channel blockers do not cure heart disease. Hypertension medications do not cure high blood pressure. Diuretics do not cure fluid retention. How many heart patients are on all of the above and still suffer a heart attack or die from chronic heart failure. It is time for medicine to chart a new course.
Because of their molecular structure, antioxidants can give up electrons to free radicals without becoming harmful. They are also called free radical scavengers. Dr. Elmer Cranton and Dr. J.P. Frankleton have written a detailed review on free radical pathology: Free Radical Pathology in Age Associated Diseases: Treatment with EDTA Chelation Therapy, Nutrition and Antioxidants. Journal of Holistic Medicine Spring/Summer, 1984. As outlined in the article, free floating metallic ions are the catalyst behind the uncontrolled proliferation of free radicals. The metallic ions can come from two sources, the toxic heavy metals such as mercury, arsenic, lead, cadmium and aluminum or from the slow accumulation of the trace minerals in cells such as copper, zinc, iron, manganese and selenium. While trace minerals are critical to human health and vital to controlling the anti-oxidant cascade, abnormally located or excessive levels of trace minerals can cause health problems. This is a major reason The Stowe Foundation supports CBER and the FDA’s involvement in writing health standards for the supplement industry. The Stowe Foundation just wants to make sure CBER knows what is doing when it writes the regulations.
The stores of iron in the body, as reflected by serum levels of ferritin, confirm that men accumulate iron. The lead content in the bones of cadavers has risen by 500% since the 1930’s. As heavy metals (lead) and trace minerals (iron) accumulate with age, the potential for free radical damage increases. In an oil refinery, the heavy metals are known as catalytic poisons. In the human body, the heavy metals are toxic to enzymes. When the catalysts in an oil refinery are poisoned by heavy metals found in the crude oil supply, the refinery does not produce gasoline. The entire operation is shut down and fresh catalyst is added to the catalytic cracking tower. When the enzymes of the human body are poisoned by heavy metals, cell function is shut down. Lose enough cells and you lose function of the organ or gland. Toxicity is a major promoter of all chronic illness.
The poisonous metals such as lead, mercury, arsenic, aluminum and cadmium react with the sulfur containing amino acids of the enzymes. When these metals react with sulfur on the amino acid cysteine or the methionine moiety of a large protein molecule, like glutathione, enzyme activity is destroyed. Life cannot exist without enzymes. Also the heavy metals react aggressively with the trace minerals and displace the biologically active trace minerals from the amino acid chains of the enzyme superstructure. The end result is a dysfunctional enzyme. Without functional enzymes, the enzymatic anti-oxidant cascade of the cells is disabled and free radical pathology rages out of control. Free radical pathology is the fuel to the fire of chronic inflammation. Chronic inflammation is now recognized as a major, if not defining part of every chronic illness.
Thus cadmium, which can accumulate in the body from cigarette smoke and by breathing second hand smoke, interrupts antioxidant protection by reacting with the sulfur containing enzyme glutathione and the selenium containing enzyme, glutathione peroxidase. The inactivation of either glutathione or glutathione peroxidase in the body blocks a critical step in the enzymatic cascade and recycling loop that provides continuous and ongoing neutralization of free radicals. Taking selenium supplements is not going to restore enzymatic function that has been compromised or inactivated by the cadmium. The offending toxin must be removed from the body to restore function. That statement was first proven during World War II, when the British created IV chelation therapy to treat sailors who were suffering from lead poisoning caused by the lead based paints used to paint the fleet. The technology of chelation therapy was rapidly adapted by the US Navy and approved by the FDA as a treatment for heavy metal poisoning. Chelation therapy was also approved in the 1950’s as a treatment for angina. Doctors who practice chelation therapy are not the “quacks” portrayed by the mainstream media.
Heavy metal toxins can completely destroy the antioxidant cascade that controls free radical pathology. Lead is now recognized as a major health hazard and yet it still ends up in our children’s toys and other heavy metals, like mercury, end up in the vaccines we give our children. Heavy metals often form the backbone of complex industrial chemicals. These chemicals end up being extremely toxic to the human body and often test to be carcinogenic. One of the primary causes of cancer is uncontrolled free radical pathology. It is also called oxidative stress. The presence of heavy metals destroys the cell’s anti-oxidant enzymatic cascade and free radical pathology runs on fast forward. The cell is literally consumed by the fire of oxidative stress. The only way to quench the fire is to remove the toxin that fuels the fire. That is pure physics and engineering.
The normal anti-oxidant cascade is described as follows; Vitamin E (tocopherol ), Vitamin C (ascorbate), the trace mineral selenium in glutathione peroxidase, the amino acid cysteine in reduced glutathione, vitamin B2 (riboflavin), and Vitamin B3 (niacin) are all interrelated in a stepwise, sequential, recycling process which provides ongoing neutralization of free radicals. If each one of these nutrients is present in adequate amounts, they can all be restored by cellular enzymes to their active antioxidant forms after reacting with free radicals. The enzymatic anti-oxidant cascade requires adequate supplies of the trace minerals and vitamins, but most importantly the anti-oxidant enzymes and their co-enzymes must be active.
The process proceeds as follows: Vitamin E neutralizes a free radical by absorbing an electron and being oxidized to tocopherol quinone. Tocopherol quinone is recycled to reduced Vitamin E (tocopherol) by Vitamin C, which in turn is oxidized to dehydroascorbate. Oxidized Vitamin C is then recycled to ascorbate by the enzyme glutathione peroxidase. Glutathione peroxidase is returned to its active form by oxidation of reduced glutathione. Oxidized glutathione is then reduced by the Vitamin B2 dependent enzyme, glutathione reductase. Glutathione reductase is reactivated by Vitamin B3 containing reduced NADH. Oxidized NAD is handed off to the Krebs cycle and participates in the production of ATP, the true fuel of the cells. There is balance and symmetry to the flow of protons and electrons. Hence free radical pathology, moderated by the enzymatic anti-oxidant cascade, leads to the production of fuel for the cells, ATP. However, uncontrolled free radical pathology is the fuel for the fire of cellular destruction.
From this stair step cycle of oxidation-reduction reactions, it is obvious that continued activity of each antioxidant step depends on an adequate supply of the next anti-oxidant in sequence. Otherwise certain antioxidants are consumed in the process. The stair step progression and interdependence between antioxidants and enzymes explains the often poor and at best equivocal results obtained from clinical trials utilizing only one antioxidant at a time. The concept that the health benefits of antioxidants can be ascertained by testing them under the gold standard of a double blind placebo controlled trial, one at a time, is pure scientific nonsense. Yet people try to test the heart and health benefits of Vitamin E, the selenium benefits for prostate cancer, the immune enhancement of zinc, the effects of B12 on chronic fatigue, can Vitamin C prevent a cold, Vitamin D against osteoporosis. The FDA must become better educated about how the body actually utilizes antioxidants before approving or disallowing health benefit claims.
For example, consider the effects of cadmium, a heavy metal that you can breathe in from second hand smoke. By attacking the enzymes glutathione and glutathione peroxidase, cadmium has two places where it can easily attack the antioxidant system. Essentially, cadmium can cripple the control of free radical activity of one entire array of antioxidants. An important biologic control mechanism is lost. Will taking a little extra Vitamin C or E be able to overcome the effects of cadmium? The answer is no and therefore just taking antioxidants will not prevent emphysema.
The answer to emphysema is to stop smoking, remove the accumulated heavy metals, neutralize the benzene compounds, restore a viable antioxidant cascade and generate healthy new lung tissue. This can all be accomplished by Nutritional Biotherapy, Cellular Detoxification and Adult Stem Cells. However, it requires all three and in the proper sequence and each protocol is patient specific. It is not scientifically possible to meet the standards of the double blind placebo control study mandated by the FDA when you are using multiple treatment modalities and each modality is custom compounded for each patient. That is the true secret of The Stowe Foundation; we have cornered the market on personalized medicine. We are waiting for the FDA to catch up.
Fortunately, with the maturation of CBER and with guidance from the National Institute of Health (NIH), the medical system is actively moving toward outcome based clinical studies. Outcome based clinical studies will pave the way for regulatory approval of human cell therapy and biological medicines. A method to achieve regulatory approval will also create the profit incentive to attract the vast capital resources it will take to move Applied BioLogics and Regenerative Medicine into the health care system. Investors in Stowe BioTherapy/Trinity BioLogics have a ground floor opportunity.
In 1978, 10 years before the True Health study on AIDS and 20 years before the US Congress mandated CBER, Dr. Gustavo Bounous in Canada, in conjunction with a colleague Dr. Patricia Konghavn from the McGill University Faculty of Medicine, initiated a novel research program to search for a dietary protein source that would boost the immune system. At the time, Dr. Konghavn’s main research was concerned with increasing basic knowledge of the immune system, with a focus on cellular immunology, host/parasite interactions and the genetics of natural resistance.
In the mid-1970’s she began a collaboration initiated by Dr Gustavo Bounous to research the influence of various dietary proteins on immune responsiveness. They published their first paper on this research in 1978 and continued their collaboration until 1989, during which period they co-authored 14 papers. This work led to the discovery of an undenatured whey protein concentrate that regulated glutathione levels and promoted immune enhancing activity. This ultimately led to the production of a high quality bioactive nutraceutical: IMMUNOCAL® in 1993.
In 1985, Dr. Stowe assisted True Health in acquiring a source of the undenatured whey protein concentrate and this was added to the protein powder that was supplied as a nutritional supplement to the AIDS patients of the True Health study. Its sole purpose was to raise intracellular glutathione levels. As highlighted above, it is critical to the human immune system to control free radical pathology and the intracellular stores of glutathione are critical to that goal. The work of Dr. Bounous and Dr. Konghavn had already demonstrated that the undenatured whey protein could regulate and restore glutathione levels. It was a simple blending process to use the special whey protein concentrate in a powdered nutritional supplement and have the AIDS patients consume it four times per day. Normal levels of glutathione are critical to an AIDS patient having a functional immune system.
The True Health powdered supplement also had the vitamins and trace minerals that it takes to support the action of the enzyme glutathione in the human body. Glutathione is critical to the liver and its ability to detoxify the body. It is common in Chinese medicine to do a liver cleanse to purify the body. It is just as important to rebuild the intracellular stores of the enzyme glutathione that have been contaminated and deactivated by the toxins. The vitamins and trace minerals are also active and critical co-factors in regulating the free radical pathology associated with cellular respiration. Uncontrolled free radical pathology leads to cellular destruction and inactivation.
A second key ingredient to the True Health formula was the addition of antigen infused colostrum extracts. By 1988, the technology of producing the Immune Milk used in Dr. Stowe’s recovery from osteosarcoma in 1959 had advanced to the point of being commercially available in the form of transfer factors, which are basically the peptides that are extracted from antigen infused colostrum. Transfer factors have been validated as molecules that can activate natural killer cells of the immune system. The story of the Immune Milk and Colostrum Extracts is posted on The Stowe Foundation website.
The bottom line is that the True Health formula of 1989 provided the AIDS patients with:
- Transfer factors based on antigen infused colostrum extracts, Immune Milk
- Elevated levels of intracellular glutathione from undenatured whey protein
- Vitamins and trace minerals to control free radical pathology
- Biological response modifiers in the form of polysaccharides from Aloe Vera
- Prostaglandins from the essential fatty acids contained in EPO and Fish Oil
- Hydration from consuming four 16 oz liquid protein shakes per day.
These six elements delivered very impressive results in 1989 with a cohort of 30 AIDS patients. They are still the foundation of Nutritional BioTherapy. The FDA’s response to the True Health study was to shut the company down on the technical premise that True Health was making unsubstantiated medical claims about AIDS. The reason given by the FDA was that the clinical study was not performed as a double blind placebo controlled study and that the safety and efficacy of each major ingredient would have to be tested and confirmed. The mainline media promptly dismissed True Health as a marketing scam. No one ever questioned or tried to challenge the scientific validity of the study. It has taken the US Government 18 years and substantial public pressure to provide a regulatory mechanism that can allow the technology to reach the market. The Stowe Foundation believes that the True Health study of 1989, repeated with the immune therapy technology of 2008, would deliver even better results.
The long saga of court battles between True Health and the FDA forced Dr. Stowe to establish a consulting business within the oil and gas industry to make a living from 1990 to 1995. During his time at Mobil Oil Research and Development, Dr. Stowe had become very knowledgeable about the effects of ultrasound and sonic vibrations on chemical reaction rates and conversions of hydrocarbon feed stocks. Dr Stowe turned this knowledge into a patented process for converting heavy oil into light oil. US Patent 5547563, which was first applied for in 1993, became the technology base for Probex Corp and was also the basis on which Dr. Stowe became a small business technology partner with Los Alamos National Laboratories. The patented technology held great promise in the creation of new environmental clean-up technology for oil spills and the recycling of used motor oil. Hence, Dr. Stowe became an invited speaker at several conferences on environmental technology and a consultant to the oil and gas industry.
However, during this time frame he also consulted with several medical device companies that wanted to use Dr. Stowe’s concepts of immune therapy as adjunctive therapy to their medical devices. The prominent client during this time frame was First Circle Medical, Inc., who specialized in whole body hyperthermia (WBH) and the potential of use of WBH in the treatment of AIDS and Hepatitis C. Dr. Stowe helped First Circle Medical, headquartered in Minneapolis, MN; recruit Dr. Gary Blick, a prominent AIDS specialist in Stamford, CT, to supervise a pilot study test of WBH for AIDS and Hepatitis C. These first tests were designed to isolate the specific effects of WBH; hence the first series of tests did not utilize Dr. Stowe’s immune therapy concepts. First Circle Medical would later test WBH in combination with the more powerful anti-viral drugs in an attempt to lure financial support from the pharmaceutical industry. That alliance effectively excluded immune therapy from the clinical studies.
As the science of WBH began to evolve, Dr. Stowe sold his interest in Probex Corp and formed the non-profit medical research foundation, Survive Until A Cure (SUAC). His co-founder was Scott Broder, a resident of Westport, CT and an independent oil trader from Wall Street who had consulted with Probex Corp on heavy oil supplies. Scott had many business associates and financial contacts that would prove invaluable to SUAC. The SUAC Foundation recruited Dr. Warren Levin, a prominent New York physician who practiced holistic medicine, to be the medical director of SUAC and the Foundation also established formal relations with Dr. Carlos Fink Serralde in Mexico City.
Dr. Carlos Fink had been part of the international development team of WBH for a competitor to First Circle Medical. As a condition to his contract, the competitor company, IDT, Inc a subsidiary of Biocontrol Technology in Pittsburgh, PA, left Dr. Fink his own whole body hyperthermia equipment for the application of the WBH therapy within Mexico’s healthcare system. This positioned SUAC to develop the WBH procedure and immune therapy, while First Circle Medical would continue to pursue WBH and pharmaceutical drug combinations.
SUAC also shifted its emphasis to WBH and cancer, a condition with more personal interest to Dr. Stowe and Dr. Levin. The medical advisory board to SUAC also included Dr. Ivan Danhof, an authority on biological response modifiers, Dr. Jeffrey Bland, an authority on functional medicine, and Dr. Hugh Fudenberg, a pioneer in transfer factors. The combination of professional expertise allowed Survive Until A Cure to lay the groundwork for understanding the cell mediated response of the immune system. The cell mediated response of the immune system is the heart and soul of comprehensive immune therapy or Applied BioLogics. The work carried out by Survive Until A Cure laid out the scientific rationale behind Applied BioLogics.
For example, the SUAC team discovered that WBH released heat shock proteins that turned out to be professional antigen presentation molecules to the dendritic cells of the immune system. Dendritic cells are the cells of the immune system that first activate and target the T-Cells to abnormal tissue such as cancer cells and invading pathogens. Dendritic cells sound the alarm of the immune response to cancer. It is also important the thymus gland be active or the T-Cell function will be impaired. Low thymus gland activity is also a hallmark condition of cancer patients. The team also discovered that a fever releases an elevated amount of immune activating cytokines. The cellular mechanics of the immune system began to unfold as we studied the body’s cellular reactions to an artificially induced fever.
It also became apparent that the aggressive form of WBH being used by First Circle Medical and IDT could be replaced with a low grade fever induced by a far infrared sauna with the immune response then being aggressively modulated with biologic response modifiers provided by Dr. Danhof and transfer factors recommended by Dr. Fudenberg. Dr. Bland provided many suggestions on the quality and type of products to be used in the Nutritional BioTherapy program for cancer patients. The entire T-Cell response was then targeted with cancer vaccines. Cancer vaccines, transfer factors and biological response modifiers are thoroughly analyzed on The Stowe Foundation website.
Dr. Stowe added the concept of cancer vaccines to the SUAC protocols after meeting Dr. Nikolaus Klehr of Germany through Ralph Moss, a medical journalist that covered alternative and complimentary medicine, and Jane Reeb, the director of Cancer Support and Solutions in Atlanta, GA. During his stay in Atlanta, Dr. Stowe became a featured speaker at Jane Reeb’s seminars on holistic cancer care. The combination of low grade hyperthermia, biologic response modifiers, transfer factors, cancer vaccines and Nutritional BioTherapy became the signature therapy of Survive Until A Cure. SUAC was operational from 1995 until the year 2000 when SUAC was disbanded under financial distress. However, a Google search on the names associated SUAC and the True Health study is the best method for understanding the technology background to The Stowe Foundation.
All of the therapies being advocated by Survive Until A Cure were experimental. They were also outside the boundaries of mainstream medical research. Many of the professionals associated with SUAC were being ostracized by the medical community and the regulatory agencies for their non-conventional approach to cancer. Hence it was difficult to raise money. Again, the arguments were not about the science. It was simply difficult to raise money for a project that flew in the face of conventional wisdom. The pharmaceutical companies had no vested interest in comprehensive immune therapy and venture capitalists only invest in products that might reach the market.
Since CBER was in its infancy, there was no method to gain regulatory approval. The concept of immune therapy had no major backing by the pharmaceutical companies and there were no powerful vested interest groups backing the technology or lobbying the NIH for money. During its five year existence, Survive Until A Cure got by on limited donations, consulting fees donated to SUAC by Dr. Stowe and his company Applied Biological Medicine and by charging for the therapy on a fee for service basis to those who where trying to find hope.
Most of the money spent by the clients on therapy went to the acquisition of the products and services needed to carry out comprehensive immune therapy. Hence the private companies of Dr. Danhof, Dr. Klehr, Dr. Fink and Dr. Fudenberg benefited far more then SUAC. The patients also had to be treated outside of the US by making trips to Germany to see Dr. Klehr, to the Bahamas to pick up a personal supply of the transfer factors and to Mexico for the biologic response modifiers and WBH. It was not an easy task and very few patients had the financial resources to cover the expenses.
Survive Until a Cure was simply ahead of its time. It was during this time that Dr Stowe authored a white paper on prostate cancer entitled: A Method To Strengthen The Immune System And Improve Survival Rates For Stage D Prostate Cancer. A copy of the original paper is posted on The Stowe Foundation website. It was never published in a peer reviewed journal, but it was highly circulated by Dr. Levin among practitioners of alternative and complimentary medicine. The fundamental concepts outlined in the paper are just as valid today as they were in 1996.
Edith Stowe developed her pancreatic cancer in late 1999 just has SUAC was being disbanded. While many individuals contributed to the success SUAC and contributed significant individual parts of comprehensive immune therapy, the integrated knowledge base was maintained by Dr. Stowe’s consulting firm Applied Biological Medicine. Dr. Stowe was therefore able to treat his mom’s pancreatic cancer by soliciting the support of her oncology team and the family physician to write the orders for the nursing home where the immune therapy would be administered and for the writing the prescriptions for the offshore medications. This was all done under the compassionate use regulations of the FDA.
It was an unusual set of circumstances that allowed SUAC’s immune therapy protocols to be applied in the US. Edith Stowe would become a single patient clinical study, under the care of her family physician, on the investigation of Dr. Klehr’s cancer vaccine for pancreatic cancer. Dr. Klehr’s cancer vaccine, based on antigen presentation and cytokine therapy is an approved medication in Germany and hence Edith Stowe could bring in a three month supply for her own personal use. The administration of the vaccine had to be under the supervision of a US licensed physician, the other parts of the protocol were considered adjunctive therapy.
Before starting the immune therapy program, the medical oncology team first applied the gold standard of care for inoperable pancreatic cancer which was radiation. The pancreatic tumor was also sensitized to the radiation by applying a low dose of 5FU, a chemotherapy drug. The treatment regimen was known as the Mayo Clinic protocol. Six weeks of radiation therapy and low dose chemotherapy reduced the tumor mass from a 9 cm tumor to a 6 cm tumor. Diagnostic imaging and the blood tumor marker CA19-9 confirmed the tumor was still active. Edith Stowe’s tumor markers were 2,500 with normal being less then 35. The prognosis was still terminal, but the oncology team was satisfied that they had provided her the best available treatment. Dr Stowe was pleased with the treatment because the radiation had clearly created cancer antigens by killing some of the cancer cells and had reduced the gross amount of active tumor by 1/3.
The comprehensive immune therapy program was applied after the radiation protocol. The immune therapy was centered on Dr. Klehr’s autologous cancer vaccine and cytokine therapy made from blood samples, Dr. Danhof’s biologic response modifiers from the aloe vera plant, Dr. Fudenberg’s transfer factors derived from antigen infused colostrum and avian sources plus Dr. Stowe’s Nutritional BioTherapy program. After 12 months of immune therapy, the CA 19-9 tumor marker had dropped to less then 30 and diagnostic imaging confirmed the tumor to be inactive and had shrunk to 2.5 cm of scar tissue.
During the one year program, the oncology team had installed four billiary stents to let bile flow freely through the bile duct. The tumor mass, although reduced in size was still obstructing the bile duct. The oncology surgeon had predicted after installing the first stent that Edith Stowe would not need a second because the tumor mass was still extremely large and it was only a matter of time before pancreatic function and liver function would fail. The billiary stents are usually replaced every 3 to 4 months in patients who had been treated with the Whipple procedure (operable pancreatic cancer) and had a favorable prognosis. Once the healing from the surgery is complete, the stents are no longer needed. The surgeon was very sure that Edith Stowe was terminal and would not need a replacement stent. After he installed the fourth he commented that no more would be needed. The third had been completely clean and free flowing and there was no obstruction to bile flow. The fourth stent would be the last required.
Edith Stowe’s pancreatic cancer had been put into a long term remission. She lived nearly three years beyond her 2 to 6 month terminal prognosis. Today that would cause the FDA to fast track any drug used to treat pancreatic cancer. However, comprehensive immune therapy is not a drug and does not fit the classic methods of testing drug efficacy.
Still, several hundreds of millions of dollars have been spent trying to create an effective pancreatic cancer vaccine. The results are always disappointing when the vaccines are forced to be tested in a stand alone fashion. The cancer vaccines only target the immune system onto the cancer cells. If the immune system has been suppressed by chemotherapy and radiation, the cancer vaccines are going to fail. Also the immune system can only handle so much cancer or tumor burden. If the cancer is highly metastatic, the immune system is going to need help. That is why The Stowe Foundation of 2008 turns to energy medicine and biological medicines that have direct cytotoxic properties. Cytotoxic properties mean the biological medicines directly attack and destroy cancer cells or disrupt the metabolism of cancer cells and they die. The energy devices are used to accelerate the effects of immune therapy and sometimes the energy fields also have direct cytotoxic properties.
As the years have progressed, it has become quite apparent that immune therapy combines quite nicely with surgery and radiation. In fact, with the creation of proton beam radiation and gamma knife technology, which are far more targeted and less destructive to the body then external beam radiation, immune therapy may yet gain a toe hold as an adjunctive cancer therapy and move up the ladder. With proper funding, The Stowe Foundation could approach Loma Linda University in California or MD Anderson in Texas about conducting a full analysis of Applied BioLogics combined with proton beam therapy. That would lead to a dramatic improvement in the standards of care for cancer.
At the conclusion of his mother’s therapy and remission of the pancreatic cancer, Dr Stowe moved his consulting firm, Applied Biological Medicine back to Fort Worth, TX. He established a relationship with several practitioners of holistic medicine in Dallas/Ft. Worth and helped open the BioTherapy Clinic of Texas in 2001. Dr. Stowe served as Science Advisor to the clinic while licensed healthcare providers took medical responsibility for patient care.
It was also during this time that Matol, a prominent network marketing company in Canada, hired Dr. Stowe through Applied Biological Medicine to develop structure and function claims for their line of nutritional products and to assist in product line development. Health benefits claims and structure and function claims all came into existence when the FDA was forced to create CBER in 1998. With the creation of CBER, the FDA had to come out with new labeling laws regarding nutritional supplements, herbs and functional food beverages and whole food supplements. Based on his work with SUAC and the True Health study, Matol considered Dr. Stowe to be the perfect spokesman for the holistic health industry. Matol arranged a North American speaking tour to promote the benefits of immune therapy. The speaking tour also became a lead generation system for patients to the BioTherapy Clinic of Texas and the international clinics associated with comprehensive immune therapy and human cell therapy.
The BioTherapy Clinic of Texas became an entry point for US and Canadian patients seeking advanced health care not otherwise available in North America. The BioTherapy Clinic of Texas evolved into the first link in a medical referral network to Dr. Klehr’s Institute for Immunology and Cell Biology in Germany (cancer vaccines and cytokine therapy), Dr. John Clements’s ITL Cancer Clinic in the Bahamas (biologic response modifiers for immune therapy), Dr. Frank Morales’ Rio Valley Medical Center in Matamoras, Mexico (human cell therapy and transfer factors) and Dr. Carlos Fink Serralde of Angeles Hospital in Mexico City (whole body hyperthermia and radiation). Dr. Ivan Danhof and the North Texas Research Laboratory supplied products and clinical support services in the field of biological medicines and Chisolm Biological Laboratory in Warrenville South Carolina continued to develop the technology behind transfer factors under the guidelines first established by Dr. Hugh Fudenberg. The BioTherapy Clinic of Texas orchestrated, coordinated and planned the strategy for the patients. The clinic was in operation from May of 2001 to August of 2005. The Stowe Foundation was incorporated in April of 2003 to support the technology development of comprehensive immune therapy and regenerative medicine.
In August of 2005, Dr. Stowe determined that The Stowe Foundation required his full time attention if the Stowe Foundation’s signature concepts of Applied BioLogics and Regenerative Medicine were going to make the transition into mainstream clinical practice. The science of comprehensive immune therapy does not require a new technology base; it requires a regulatory approval strategy. The goal of The Stowe Foundation, starting in the fall of 2005, became a focused effort to gain regulatory approval for Applied BioLogics and Regenerative Medicine.
By the summer of 2005, it had become abundantly clear that comprehensive immune therapy was most effective when the major biologic agents, such as cancer vaccines and transfer factors, where custom compounded for each patient and the biologic response modifiers were individually dosed and genetically matched for each individual patient. Applied BioLogics is the epitome of personalized medicine when;
- the cancer vaccines are tailored made for each individual patient from their own blood and tumor samples
- the patient specific transfer factors for modulating chronic inflammation are designed around the pathogens and living microorganisms actually harvested from the patient’s blood and tissue samples
- the environmental and metabolic toxins that have accumulated in the patient’s body over time are accurately identified and characterized through hair, urine and stool analysis
- the energy disturbances that are suppressing biological activity of the body’s organs, glands and tissue beds are properly catalogued and imaged
- the appropriate clathration, chelation, oxidation or neutralization agents are applied to the detoxification process
- the therapeutic levels of the biological response modifiers and biological medicines are individually dosed and adjusted to the patient’s genetic predispositions
- the enzymatic pathways that control anabolic metabolism and cellular respiration are properly nourished
- the energy meridians of the body and the energy fields of the vital organs, gland and tissue beds are restored to homeostasis
It was also clear that adult stem cells, which had been studied in Europe, Israel, South America, China, Russia and Mexico had the most clear and direct path to establishing a therapeutic benefit within the CBER guidelines for human cell therapy. The Stowe Foundation also believes that adult stem cells are the only ethical source of stem cell therapy. Hence the focused mission statement of the Stowe Foundation since August of 2005 has been to bring Applied BioLogics and Regenerative Medicine into regulatory compliance and to advance the science of adult stem cell therapy.
A Defining Month in The Stowe Foundation - Feb, 2005
Dr. Larry Stowe met with Dr. Carlos Fink Serralde in Phoenix, AZ in Feb 2005 to attend the XVIII International Congress of the International Society of Endovascular Specialists that was hosting a professional stem cell meeting and discussing the therapeutic benefits of human cell therapy to cardiac care. Dr. Stowe attended as part of The Stowe Foundation’s efforts to build a comprehensive immune therapy program for the heart. The meeting was a professional society meeting of cardiovascular surgeons, hosted by Ted Diethrich, and Dr Nabil Dib of the Arizona Heart Institute. The Congress was bringing together many of the international experts on stem cell therapy, which included experts on both adult stem cells and embryonic stem cells. The FDA was there to explain the regulatory procedures being utilized by CBER for getting human cell therapy into clinical trials.
Kevin Benoit of Harvest Technology was present at the meeting trying to attract interest in their medical centrifuge as a source of bone marrow concentrate. It is a point of care device that can deliver large numbers of the human bone marrow cells that research scientists had been using in their work. Dr. Aviles from Spain was at the meeting presenting a paper on their success in cardiac repair using purified progenitor cells captured from the bone marrow. Dr. Fink had been in communication with Dr. Aviles and Dr. Fink was gathering information on the stem cell protocol used in Europe. We all met at the meeting and I immediately recognized the value of the Harvest Technology device to the Stowe Foundation program. Most other organizations at the meeting had their own proprietary technology for the production of the adult stem cells. Hence, The Stowe Foundation became the one interested customer Harvest Technology was able to attract.
At the time, Dr. Fink and the Stowe Foundation were working on a protocol for cardiac care using adult stem cells to be recovered from peripheral blood or bone marrow. We were in fact at the conference to survey the various technologies for producing stem cells. The fit with Harvest Technology was immediate. Keep in mind that adult stem cells are only one part of a comprehensive immune therapy protocol to reverse heart disease. Tissue repair of the heart is only one step in reversing a myocardial infarction. The second step is to apply immune therapy to reverse the heart disease process. It is important to realize that each organ of the body will require its own protocol to achieve safe and effective cell therapy.
The method used to repair the heart will not be the same method used to repair the liver or lungs. The delivery mechanism of the cells, the mixture and number of cells required for repair, the presence of important co-factors and the bio-terrain to induce differentiation must be created for each organ of the body. Human cell therapy is a fertile field for patented technology. The Stowe Foundation was intrigued about the potential of using the Harvest Tech bone marrow concentrate because the concentrate would deliver a physiologic balance of immune competent cells and it is the only point of care source of stem cells. Point of care service is a key concept for the military field hospitals and hospital emergency rooms. No one is currently pursuing this avenue for human cell therapy. The question remained; does this produce a safe and effective result? Hence the Stowe Foundation sponsored the large animal studies at Charles River Labs on canine hearts and the equine studies on cartilage repair at Cornell.
It is important to note that actually using adult stem cells in a therapeutic manner is more then just locating a source of the adult stem cells. The adult stem cells do not work in isolation from the rest of the immune system to heal and repair the body. There is a complex set of molecular interactions that must occur in order to initiate tissue repair. The stem cells do not work in isolation from other immune competent cells found in the body. The co –factors are classically known as cytokines, growth factors, platelets, lymphocytes, mononuclear cells, etc. There is a large need to fully identify and characterize these cells to unravel the mystery of how the immune system can repair tissue in the human body. The Stowe Foundation and our signature concept of Applied BioLogics is the world leader in understanding comprehensive immune therapy.
The mechanism behind tissue repair is not fully understood. Many factors influence the tissue repair mechanism. There are many variables that will go into the equation. This complicates the development of human cell therapy that can be certified as safe and effective by the FDA. The regulatory environment of the USA requires that any therapeutic procedure must be demonstrated to be safe and effective before it can be marketed to the US public. This requires an understanding of the mechanism of the immune system. It is the entire protocol that constitutes the intellectual property of the Stowe Foundation and hence human cell therapy is an area for patent protection. The Stowe Foundation is creating human cell therapy; the source of the adult stem cells is just one component.
We will eventually have to apply to the FDA for an IND status (Investigative New Drug) on the bone marrow concentrate. That will be the role of the CBR Institute for Biomedical Research in Boston, a consultant to Harvest Technology and the medical school at the University of California San Diego (UCSD). The Stowe Foundation will fund sponsored research at UCSD and the CBR Institute to guide the FDA process and the development of the basic science behind human cell therapy. This will be done through the Stowe Foundation’s New Horizons Research and Development division and the BioTherapy Research Institute.
To exemplify the need for detailed work on the bone marrow concentrate, Dr. Vacanti of Harvard has published an interesting article in the Scientist in a 2004 issue about the potential existence of a true pluripotent adult stem cell that might be found in all human tissue. No information was given about the character of the cell (except for an interesting comment about size), how to identify the cell, how to harvest the cell or how to therapeutically use the cell. The paper was simply an intriguing hint that a pluripotent adult stem cell might exist.
After reading the article, Dr. Stowe contacted Dr. Vacanti about a mutual research and development program for the pluripotent adult stem cell. The Foundation has its own concepts that this cell had to exist, but Dr. Vacanti is associated with an elite research group in tissue engineering and it seemed combining forces could accelerate the results. That is part of the Stowe Foundation’s philosophy, to locate the proper strategic partners to accelerate technology development. It is why we have the New Horizons R&D arm of the Foundation. Our public charity status mandates that we seek out those partners as long as they qualify for doing 501c3 work.
The Foundation’s experience on wound healing of race horses had partially demonstrated that fat tissue found in horses contained a pluripotent adult stem cell. The work we had done with peripheral blood also contributed to our belief that the pluripotent adult stem cell did indeed exist. It was slowly becoming apparent that the source of the Universal Pluripotent Adult Stem Cell (UPS cell) had to be the bone marrow. Dr. Vacanti and his group elected to pursue their own development work on tissue engineering, which is to grow new organs or tissue in the lab and then transplant the final lab grown organ into the body. They feel they can control the entire process in the lab better then you can grow new tissue in the body where there are a lot of variables. The Stowe Foundation holds an entirely different opinion
The Stowe Foundation and in particular Dr. Larry Stowe, Dr. Carrier and Dr. Dib believe the source of the adult stem cell found in the other tissues of the body must come from the bone marrow. The bone marrow is the source of all immune competent cells found in the blood and bone marrow is the source of the progenitor cells used in the German and Spanish work on cardiac repair. Bone marrow is the tissue bed where all progenitor cells are created. In the biological progression of events, it is highly unlikely that progenitor cells are simply the first blood product produced by the bone marrow. Progenitor cells are likely produced as a step in the natural differentiation process of the pluripotent adult stem cell found in the bone marrow. A certain fraction of the bone marrow pluripotent adult stem cells make it into the peripheral blood for distribution to the rest of the body. The different organs then end up with a reservoir of progenitor cells and the pluripotent adult stem cell to affect daily tissue repair or growth.
The human body is originally produced at birth from embryonic stem cells. Embryonic stem cells generate embryonic progenitor cells. Embryonic progenitor cells produce embryonic tissues. In the adult, it is my belief that both the progenitor cells and the adult stem cells found in the other tissues of the body originate in the bone marrow. The blood is the transport medium. The different tissue beds all have the correct surface cell receptors to tell the blood what progenitor cells they will accept and the pluripotent adult stem cells are universal. This is how tissues regenerate. It is the adult version of the original birth and growth process. The secrets of human cell therapy lie in the bone marrow.
A catastrophic event such as a myocardial infarction or stroke simply overwhelms the number of stem cells and the progenitor cells available for tissue repair. Scar tissue results to seal the wound. We can intervene in the process by delivering a therapeutic dose of the adult stem cells, the progenitor cells and the co-factors to the damaged tissue to grow new tissue, essentially repeating how the body was created. What we do not know is how the body tells the stem cells what to become. Cell to cell communication is a very open area of research. Based on my experience with bioactive energy fields involving far infrared light, laser light, microwave energy, ultrasound, sound, magnets, electricity and mechanical vibrations, I know the answer will reside as much in energy medicine as it does in the biochemical model. We will unlock the energy code and be able to direct the tissue repair by mimicking the cells signaling mechanisms. The energy field is likely to be in the quantum physics range of intensity.
Recent stem cell research has also revealed the tremendous power of umbilical cord stem cells to generate new tissue. Umbilical cord stem cells are essentially the same as the adult stem cells found in the bone marrow only they are younger and more vibrant in their activity. A recent article published by National Geographic stated it best:
Umbilical Cord Blood: The Future of Stem Cell Research?
For National Geographic News
April 6, 2006
Researchers at the University of Minnesota recently announced that they were able to largely reverse the effects of stroke in lab rats using stem cells found in human umbilical cord blood. In the experiment, conducted by neurologist Walter Low and his colleagues, the transplanted stem cells took on properties of brain cells and seemed to spur the rats' brains to "rewire" themselves.
The researchers almost fully healed the rats 48 hours after the animal’s sustained brain damage. Typically doctors need to act within three hours to treat a human stroke patient successfully.
Cord-blood cell transplants are already becoming common as a therapy for diseases of the blood. Now scientists like Low are finding that stem cells from umbilical cord blood—once thought capable only of turning into blood cells—may be able to grow into other kinds of cells as well. Such advances are casting cord blood, previously regarded as medical waste left after childbirth, in a new light. But while experts are optimistic about the future of cord blood as a source for new stem cell therapies, they disagree about how this potentially life-saving resource should be handled.
An Appealing Source of Stem Cells
It's not clear yet whether the therapy Low's team used on rats will ever be safe or effective in humans. But many people with other life-threatening conditions have been healed with this easily collected source of stem cells. Today doctors use cord blood cells to treat about 70 diseases, mostly anemias or cancers of the blood, such as leukemias and lymphomas.
Patients with immune-system diseases—like Severe Combined Immunodeficiency, commonly called the Boy in the Bubble Disease—have also responded to cord blood treatment. "[Cord blood stem cells] can be used to replace failed blood cells," explained Kristine Gebbie, a professor of nursing at Columbia University in New York. Six thousand patients worldwide have been treated with cord blood stem cell transplants to date, though the U.S. Food and Drug Administration still considers the procedure experimental.
For the therapies, doctors typically obtain cord blood from the placentas of volunteer donors after they give birth. The blood is then banked with one of several public registries. If the donor and patient aren't genetically similar enough, the patient's body will reject the transfusion. The result can be fatal. "A war goes on [between donor and recipient cells], and you want the donor [cells] to win," said Mary Laughlin, an expert in cord blood transplantation on the faculty at Case Western Reserve University in Cleveland, Ohio.
But cord blood transplants are more forgiving than other procedures, like bone marrow transplants, if the donor isn't a perfect genetic match. And as volunteer donor banks grow, patients are often able to find suitable cord blood donor matches months before they might identify an appropriate bone marrow donor.
The Center for Cord Blood in Minneapolis, Minnesota, the largest public donor bank in the United States, reports that the likelihood of finding a perfect match in its bank has doubled in the last four years. The center's Web site states that more than 95 percent of patients searching its registry are able to find suitable matches today. Some companies, however, are encouraging families to save their own cord blood rather than donate it.
Keep It in the Family?
Each year thousands of new parents arrange for their newborns' cord blood to be saved and cryogenically frozen by private cord-blood banking services. Families pay cord-blood banks up to U.S. $1,700 to freeze the blood, plus an annual storage fee of around $125. The child and his or her family will then have exclusive use of the cells if the need for a transplant should arise.
A child's own cord blood is guaranteed to be a perfect match for that child. This means there's theoretically no chance that the cells will be rejected after transplantation. But in the case of some diseases, doctors consider it unwise to use a child's own cord blood cells for treatment, says Columbia University's Gebbie.
Gebbie chaired a panel that advised the U.S. federal government regarding cord-blood banking. "The cells may already carry in them the seeds of the cancer that you are trying to treat [in the child]," she said. In other words, in cases of some genetic diseases, including many leukemias, doctors fear they would end up transplanting cells that would later become cancerous if they used a patient's own cord blood for the procedure.
For this reason, most transplants using privately stored blood are performed on the donors' siblings, explains Morey Kraus. Kraus is chief technology officer for ViaCell, a Cambridge, Massachusetts-based company that offers a private cord-blood banking service called ViaCord. "There's a higher probability of finding a match in the family than in a registry," Kraus said.
Experts agree that the odds are better that a patient will have a successful transplant from a donor who's a sibling rather than someone who isn't related. But neither the American Academy of Pediatrics nor the Leukemia and Lymphoma Society recommend that parents of healthy children should store their child's cord blood with private banks.
Gebbie agrees. "Were I still in a child-bearing mode, or if my daughter during her two recent pregnancies had asked me [if she should bank her baby's cord blood], I would have said, No," she said. "It's an ongoing cost that has very little promise of being useful or successful for your child."
Some medical studies, like a 1997 report from the Journal of Pediatric Hematology/Oncology, estimate that there's a 1-in-2,700 chance that a child will get a disease that's advisable to treat with the child's own blood. The chance that a child will get a disease that's treatable with a sibling's cord blood is much more likely. ViaCord's Kraus says that chance is about 1 in 328.
But Laughlin, of Case Western Reserve University, says those numbers don't tell her much. She estimates that a child has roughly a 1-in-100,000 chance of getting acute leukemia. "Then 85 percent of those 1 in 100,000 are cured with chemotherapy," she said. "They don't need a transplant. Childhood leukemia is very curable now just with chemotherapy. So that reduces 1 in 100,000 to 1 in 800,000."
Laughlin says the incidence of those diseases for which cord blood is typically used is too low to warrant private banking. But preliminary research on more common disorders, like Low's stroke studies in rats, has her looking toward the future. Laughlin is betting, for example, that diabetes will be treated one day by cord-blood transplants. ViaCord's Kraus said, "There's a huge uncertainty out there about where stem cell technology will come from and what kinds of stem cells will be used to treat what were formerly considered incurable diseases."
Building the Public Infrastructure
Minnesota's Low says he would prefer parents donate cord blood to a central reserve that's available to everyone, strengthening existing public banks. "To me, that makes more sense," he said. "You make sort of a national cord-blood bank that everyone can deposit into and everyone can draw from." He's not the only one thinking this way.
In 2004 the U.S. federal government set aside money to establish a central system for cord blood banking, to be facilitated by the Department of Health and Human Services. Last year President George W. Bush signed into law the Stem Cell Therapeutic and Research Act, which supports building a reserve of 150,000 cord blood units from ethnically diverse donors.
Gebbie is optimistic that an effective national system will be in place soon. The biggest challenge, she says, is getting more units from minority groups. Because of limited donor pools, minorities have had difficulty finding suitable matches. Fixing that will require outreach and advertising to those communities. But, she said, "it's not a ten-year project."
The Stowe Foundation and Regenerative Medicine
The Stowe Foundation is creating human cell therapy that can be certified as safe and effective by the FDA. The human cell therapy will be based on our proprietary understandings of how to safely and effectively deliver stem cell transplants to repair or regenerate new tissue and organs with point of care service and to simultaneously eliminate the chronic inflammation responsible for the progressive degeneration of the vital organ or injured tissue. The Stowe Foundation will also support stem cell therapy for the veterinarian business. Each tissue or organ of the body will require a separate procedure. The protocols are novel combinations of different medical devices, biological medicines and surgical procedures. The Stowe Foundation represents the first time these devices, procedures and biological products have been combined in the attempt to deliver a safe and effective human cell therapy. The IP is worthy of patent protection.
The protocols will be optimized as our knowledge and experience grows with each individual protocol. For example one protocol will be required for acute myocardial infarctions and one for chronic heart failure patients. For chronic heart failure patients there will probably need to be distinct protocols for treating patients who had by-pass surgery and one protocol for those who had stents to treat the myocardial infarction. The FDA recognizes the novel nature of the procedures by requiring first laboratory studies to identify and characterize the biological blood product, followed by large animal studies to demonstrate the safety and efficacy prior to human clinical studies and then a round of phase I clinical trials on humans to proof safety, progressing to phase II studies for efficacy and then multi center phase III studies for proof that the results can be duplicated.
Treating knees and joints will require distinctly separate procedures from the cardiac care protocols. Treating cirrhosis of the liver induced by alcohol will be different then treating cirrhosis induced by Hepatitis C. Treating emphysema of the lungs from tobacco smoke will be a distinct protocol. The FDA will require the entire round of laboratory studies on the biological agents, the animal studies and the human clinical studies. The Stowe Foundation technology platform will guide those studies. The FDA certifications obtained by The Stowe Foundation have been licensed to Stowe BioTherapy for commercial application. The commercial applications provide royalties to the Stowe Foundation to expand the mission of the Public Charity. It is a true public/private partnership to change healthcare in the US and throughout the world.
The technology platform now under investigation by the Stowe Foundation includes adult stem cells from the patient’s bone marrow, treated umbilical cord stem cells to remove the immune rejection, biological medicines, autologous vaccines, patient specific transfer factors and advanced energy medical devices. It is all supported and built around Applied BioLogics. The human immune system must be properly nourished or it will not work. Conversely, getting a chronic illness into permanent remission is more then just changing to a healthy diet.
The original paperwork filed in 2003 with the IRS was to register The Stowe Foundation as a private 501c3 non-profit medical research foundation. This would permit the Stowe Foundation to seek out financial donations and to work with other philanthropic organizations. During the registration process, the IRS determined that work of the Foundation was being done in the public’s interest and the work enjoyed broad public support. Hence in January of 2005, the IRS registered the Stowe Foundation as a 501c3 Public Charity.
In August of 2005, Dr Stowe closed his immune therapy clinic, the BioTherapy Clinic of Texas, to dedicate full time to the Stowe Foundation and the development of adult stem cell therapy. By 2005 many of the immune therapy protocols had matured to a very high level. Adult stem cells produced by the bone marrow are the heart and soul of the human immune system. Adult stem cells are the focus of Regenerative Medicine and Applied BioLogics is the central theme of Comprehensive Immune Therapy, a very advanced form of Personalized Medicine. The Stowe Foundation is a unique facility where the science and technology of Applied BioLogics and Regenerative Medicine can be supplied to the benefit of the patient. The Stowe Foundation opened it first Center for Regenerative Medicine, Stowe BioTherapy on June 30, 2007 in San Diego, CA.
Stowe BioTherapy – Medical Oasis
Stowe BioTherapy is the legacy that honors Edith Stowe. The medical oasis in San Diego, CA is available to all who wish to utilize the biological techniques that put her encounter with pancreatic cancer into remission and put her son’s osteosarcoma into remission. It is the entry point for access to the healing powers of adult stem cells. It is a beacon of hope for those who face a chronic illness and it is a place where all can come to repair a traumatic injury. Stowe BioTherapy is in fact the future of Surgery and Medicine.
The Stowe Foundation
Registered as a Public Charity, The Stowe Foundation has the same legal standing as the American Cancer Society, The American Diabetes Association, The American Heart Association The United Way, The Red Cross, and Habitat for Humanity plus other caused based national charities. Our belief is that patient specific and personalized immune therapy; coupled with Regenerative Medicine using adult stem cells, holds the key to finding a cure for chronic illness in all of its forms. The protocols that evolve from The Stowe Foundation technology platform will be certified to the new standards of CBER and the FDA. The clinical studies will be conducted at Stowe BioTherapy and The Stowe Foundation will help fund those studies.
Regenerative Medicine holds the key to reversing diabetes, heart disease, arthritis, cancer, MS, ALS, Lupus, stroke and spinal cord injuries. Each condition has the potential to be reversed with the aggressive application of comprehensive immune therapy to restore the body’s natural ability to heal itself coupled with adult stem cells to regenerate the organs, glands and tissues that have been damaged by the disease process. The Stowe Foundation refers to comprehensive immune therapy as Applied BioLogics and the use of adult stem cells recovered from the patient’s bone marrow and donor’s umbilical cord blood as Regenerative Medicine.