The Stowe Foundation

Immune therapy and autologous adult stem cells are the backbone of the Stowe Foundation’s approach to natural healing. The Foundation’s primary objective is to be the vehicle that carries natural healing (Regenerative Medicine plus Applied BioLogics) through the FDA approval process. In a major advance for adult stem cell technology, the Stowe Foundation and its technology partners have gained approval from the FDA for adult stem cell therapy in orthopedic surgery; knees, hips, backs and joints. This will lay the groundwork for expansion of the technology to additional therapeutic benefits.

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.

The BioTherapy Research Institute, a division of the Stowe Foundation, will supervise the human investigational studies required to obtain FDA certification to use adult stem cells to repair the heart, lungs, liver and pancreas. The BioTherapy Research Institute will also operate the molecular biology lab where the Foundation will produce the adult stem cells for human cell therapy, the autologous vaccines for targeting the immune system on infections and cancer cells, the biological response modifiers to control inflammation, the transfer factors to modulate the immune system response and the novel plant extracts to custom compound biological medicines. These technologies form the basis of the Foundations signature concept, Applied BioLogics. A comprehensive description of Applied BioLogics is available under a separate cover.

Registered with the IRS 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.

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 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.

Since my first presentation of the adult stem cell technology in San Diego at the 2004 National Medical Association, the Stowe Foundation has made significant progress toward our goal of making adult stem cell transplants a reality. The effect of transplanted adult stem cells in the human body is to generate new tissue in organs such as the heart, liver, lung and pancreas. The stem cells can also repair damaged nerves, muscles, joints, spine and bones. Hence we are on the verge of creating new methods to treat heart disease, stroke, diabetes, hepatitis C, lymes and other biological infections, pulmonary disease, cancer, burns, arthritis, spinal cord injuries and torn cartilage and ruptured tendons in the knees, ankles and other joints.

The implications for sports medicine are phenomenal. It is now possible to envision the day when there can be a complete recovery from a traumatic knee injury in 90 days as opposed to an entire year or more. The wear and tear on bone, cartilage, tendon and muscle can be repaired during the athletic season to prolong careers. The biological age of the athlete can be reversed. All applications of adult stem cells are administered through our treatment center, The BioTherapy Research Institute, in coordination with Dr. Carlos Fink Serralde of Angles Hospital-Pedregal in Mexico City and the other Principal Investigators recruited to supervise the clinical trials. Adult stem cells are the tissue regeneration portion of a complete immune therapy program to eradicate chronic illness.

Chronic illness can be treated with immune therapy through the Stowe Foundation’s signature concept of Applied BioLogics, the rational application of biological medicine to reverse the PITTS Syndrome. The PITTS Syndrome describes the five major physiologic conditions that can suppress the immune system; Poor Nutrition, Infections, Toxins, Trauma and Stress. By reversing the PITTS Syndrome with Applied BioLogics, the human immune system can be restored to full health and vitality and the body can heal itself. The adult stem cells are the final building block to permit new tissue and organs to be grown.
The Foundation is sponsoring a study of transplanted adult stem cells to the heart. This investigation will meet all of the standards required by the FDA to be classified as a phase II clinical trial. Dr. Carlos Fink Serralde, a prominent cardiovascular surgeon at Angeles Hospital – Pedregal in Mexico City, will supervise the study. The Stowe Foundation has retained two US based consultants, Dr. Sherwin Kevy, MD and Dr. May Jacobson, PhD to provide expert guidance regarding FDA standards. Angeles Hospital is part of Grupo Angeles; Mexico’s premier network of private hospitals that meet US standards of care. The goal of the study is to prove adult stem cells can regenerate a functional heart without the need of a heart transplant. The patient base will be drawn from chronic heart failure patients. The information gathered in Mexico will be supplied to the FDA to gain approval for human clinical studies in the United States.

Following the completion of the cardiac repair study, the Foundation intends to demonstrate the adult stem cells can be used to repair the pancreas of a diabetic, the lungs of an emphysema patient and the liver of a hepatitis C victim. These patients will first be treated with immune therapy to prepare the organ for adult stem cell transplants.

Each injured or diseased area of the body requires a unique transplant procedure and a unique set of targeted immune therapy protocols. The organs were selected to make advances against smoking induced emphysema, alcohol and virus induced cirrhosis of the liver and adult onset diabetes. Each is a major worldwide epidemic and there are not enough organ donors to service the demand for organ transplants. 85% of the patients waiting for liver transplants die before a donor is located. Success in this endeavor will allow medicine to take a quantum leap forward. The stem cell transplant procedures for organ regeneration will be developed by the Grupo Angeles surgeons and the data collected will be submitted to the FDA to gain approval in the United States for adult stem cell transplants. Organ regeneration can also be used to reset biological time clocks as part of an age regression program.

It is important for the public to recognize that the Stowe Foundation does not use embryonic stem cells. Our research objective is to recover or harvest pluripotent adult stem cells from each individual patient we treat. The identification and recovery of pluripotent adult stem cells is a major scientific breakthrough.

Pluripotent means the adult stem cells can differentiate into (become) any other cell of the body. The harvested adult stem cells are then expanded (grown to a large number) in a microbiology lab to generate a sufficient quantity of the adult stem cells to repair the damaged organ or tissue. The expanded stem cells are then surgically transplanted into the patient. There is no immune rejection of the transplanted stem cells because they came from the patient. In fact, the BioTherapy Research Institute has created a system of immune therapy protocols to speed the healing process. The immune therapy protocols are a second source of proprietary technology held by the Stowe Foundation. The end result is new healthy tissue is generated and the organ repairs itself.

In that vein, the Stowe Foundations most compelling research program is the potential to discover and characterize a truly pluripotent adult stem cell. The term pulripotent is used to describe the ability of the stem cells to change or differentiate into any other cell of the body. It has been assumed by most stem cell scientists that only embryonic stem cells, those stem cells recovered from a human embryo, could be pluripotent. Embryonic stem cells are typically harvested from an aborted fetus or from a human embryo grown in the test tube. Right to life advocates and most religious organizations and faiths oppose embryonic stem cells. All the controversy in the United States about stem cell research centers on the source of the embryonic stem cells. The work of the Stowe Foundation and the discovery of a pluripotent adult stem cell will end all objections to stem cell research. The Vatican has written a position paper supporting adult stem cell research. The Stowe Foundation is a strong faith based public charity that wishes to supply the financial resources to move adult stem cell technology into the mainstream.

Our proprietary transplant procedures will incorporate the technology of harvesting pluripotent adult stem cells from each patient, growing the stem cells in a microbiology lab to create an unlimited number of the pluripotent cells and then transplanting the adult stem cells into the damaged tissue or organ. Once the stem cells are transplanted, immune therapy protocols are applied to accelerate the healing process. In patients dealing with a disease, such as cancer or a viral infection, the BioTherapy Research Institute applies very advanced immune therapy protocols to stabilize the patient before the stem cells are transplanted. The Stowe Foundation is finishing the study of two very powerful biologic response modifiers that can have a major effect against cancer cells and infectious organisms. The combination of immune therapy and stem cells transplants is going to bring hope to every victim of a chronic illness or traumatic injury.

The adult stem cells transform into new tissue and heal the body. It is this technology that Dr. Fink and the Grupo Angeles surgeons are going to investigate. The human clinical studies will start with the simple infusion of bone marrow concentrate into the heart. The bone marrow concentrate contains a broad spectrum of immune competent cells including adult stem cells. Dr Fink and his staff have been supported by two of the top European investigators of cardiac stem cells; Dr. Francisco Aviles, the vice president of the European Society of Cardiology and director of the Instituto de Ciencias de Corazon at the Hospital Clinico Universitario de Valladolid, Spain and Dr. Andreas Zeiher Chairman of the Department of Medicine, University of Frankfurt, Germany. Dr. Aviles and Dr. Zeiher are two of the more prominent international leaders in the field of adult stem cell transplants to the heart. Both cardiologists use advanced infusion techniques to deliver the adult stem cells to the heart and both have reviewed their surgical procedures with Dr. Fink and his medical team.

In addition, Angeles Hospital and Dr. Carlos Fink have a longstanding professional relationship with the Arizona Heart Institute, one of America’s leading institutions for cardiac and endovascular care. The Arizona Heart Institute, headed by Dr. Ted Diethrich, has its own investigations into the repair of the heart using the injection of muscle progenitor cells known as myoblasts, www.myoblast.org. Their experience in dealing with the FDA on the creation of the myoblasts and the complex surgical procedures required to inject the cells will be a valuable resource for Dr. Fink. The Stowe Foundation provides Dr. Fink the financial resources to fully utilize his professional network.

The Foundation has been working with Harvest Technologies (www.harvesttech.com) to demonstrate the therapeutic benefit of bone marrow concentrate that is rich with adult stem cells. The Foundation has paid for the large animal studies on dogs to prove the safety and efficacy of infusing bone marrow concentrate collected by the Harvest Tech device directly into the heart. The animal studies were conducted by Charles River Labs (www.criver.com), one of the premier research centers for animal studies in the United States. This data will be submitted to the FDA in support of the human clinical studies in Mexico and to assist Harvest Tech in their medical device applications.

The phase II clinical study in Mexico will be conducted on chronic heart failure patients. It will start with the straight infusion of bone marrow concentrates from the Harvest Tech device into former myocardial infarct patients who have current heart stress. We will follow the functional improvement of the heart at three months, six months and one year. During this time frame, the Foundation will investigate getting a stem cell expansion program developed that can gain approval from the FDA for creating a new blood product. The new blood product will involve its own round of animal tests. The Foundation would incorporate the expanded stem cell protocol into a second round of clinical tests in Mexico as soon as feasible.

The ultimate goal of the Stowe Foundation is to have US citizens be able to receive stem cell transplants. In the near term, the transplants would be done at Angeles Hospital in Mexico, once the formal clinical study is finished in Mexico City and the Minister of Health has approved the procedure for release to Mexico’s health care system.

The BioTherapy Research Institute, the clinical arm of the Stowe Foundation, will help open an outpatient clinic in San Diego, CA to supervise the immune therapy aspects of the treatment and to harvest the adult stem cells for expansion. The actual production of the expanded stem cells will occur at a nearby private microbiology lab leased by the Stowe Foundation. When the stem cells are ready, the patient will transfer to Angeles Hospital to receive the transplant. The patient will spend two to three days at Angeles Hospital and then return to San Diego for additional immune therapy. The Stowe Foundation will test four applications of the stem cell technology to repair vital organs on 120 patients at Angeles Hospital. Transplants will be performed on 30 patients in each of the following categories: heart, liver, lung and pancreas. The heart patients will be selected from those who are recovering from a myocardial infarction (heart attack). The liver patients will come from those with cirrhosis of the liver. The lung patients will be emphysema victims, the pancreas patients from adult onset diabetes.

Lisa Fortier, DVM, PhD of Cornell University and Assistant Professor of Large Animal Surgery will be conducting a study on the ability of adult stem cells to regenerate damaged cartilage in horses. The FDA accepts the cartilage damage model used at Cornell for the study of osteoarthritis. The Stowe Foundation sponsors Dr. Fortier’s work in cartilage repair. Upon the completion of Dr. Fortier’s studies, showing safety and efficacy of the procedure, the Stowe Foundation will apply to the Minister of Health in Mexico to conduct human studies.