Global Cell Med (GCM) is not a household name, but someday that could change. The organization, based out of the Bahamas, under the direction of Dr. Alejandro Mesples has been working on a procedure to treat Diabetes Type One, a global epidemic currently affecting more than 30 million adults and children in the US alone.
We are pleased to be sharing their important work and look forward to helping them reach their goals once we launch our Einsteinium Accelerator later this summer.
To learn more about the organization and their cutting edge procedure, please visit their website (http://stemcellnorthamerica.com/) and you can read their project summary here:
EXHIBIT A PROJECT SUMMARY GLOBAL CELL MED USA
Global Cell Med USA is a medical biotechnology company that is involved in the treatment of type 1 diabetes in humans. Specifically focused on the diabetes treatment protocol created by Alejandro Mesples, M.D., an internationally recognized researcher in regenerative medicine who specializes in the treatment of diabetes and vascular diseases.
Diabetes is a growing epidemic and it is global. In the United States alone, 30.6 million children and adults (10-13% of the population) have diabetes. Currently, one in three newborns in the U.S. are projected to be diagnosed with diabetes during their lifetime. The World Health Organization claims diabetes is an epidemic without control. It is one of the leading causes of mortality in the world, causing over 6 million deaths annually. Diabetes is the 7th leading cause of death in the US.
Current treatment for type 1 diabetes does not have any healing outcomes and is very disruptive to quality of life. Diabetes can cause vascular disease that causes cerebral infarcts, heart disease, blindness, kidney failure that can lead to dialysis, and neropathy of the lower limbs that can lead to amputation.
It also creates massive costs and expenditures for individuals and healthcare systems. In the U.S., the total annual economic cost of diabetes in 2015 was an estimated $245 billion.
In the time it takes to read this summary, 161 diabetics have died and 1200 have lost a limb.
Type 1 Diabetes
The human body has a complex system to convert digested food into energy, which is necessary for survival. The body’s digestive system converts digested food into glucose, often referred to as blood sugar, and it is deposited into the blood stream. The glucose in the blood stream is taken into cells where it is converted to glucagon, the body’s energy source. Insulin is the key enzyme in this process and it is made primarily in the islet cells within the pancreas. Type 1 diabetics have none or very small amounts of naturally produced insulin in their bodies. They cannot convert blood sugar into glucagon so they have no way to produce life supporting energy.
Unfortunately, type 1 diabetics are predisposed to diabetes. It is a generic disease so one cannot be naturally infected with the disease. Generally some kind of trigger, either internal and/or external, signals the diabetic’s autoimmune system to treat their islet cells in their pancreas as an antigen or foreign invader to the body. The autoimmune system then destroys the insulin producing islet cells and the process for creating energy for the body.
The only current effective strategy for treating type 1 diabetics and preventing death is to inject diabetics with insulin throughout the day on a predetermined schedule. Insulin treatment is invasive, complicated to use, and very expensive.
Dr. Alejandro Mesples’ Type 1 Diabetes Treatment Protocol
The therapy strategy invented by Dr. Alejandro Mesples is patent pending. It is based on the utilization of a diabetic’s own stem cells within their bone marrow. A patient’s bone marrow is stimulated using a drug called Filgrastim and then the stem cells are aspirated from the iliac crest bone. Those bone marrow stem cells undergo another regime of preparation before they are reintroduced back into the patient. The aspirated and prepared bone marrow stem cells are then transplanted into the patient via intravenous injection – an ambulatory procedure. Dr. Mesples’ treatment does not use autoimmune suppressant drugs or cell culture.
Three governments, Argentina, Chile, and Bahamas, have approved this therapy. The University of Miami Medical Stem Cell Division completed an Independent Review Board Opinion on the efficacy of the treatment protocol, approving the treatment as a consultant for the Bahamian National Stem Cell Committee. Dr. Mesples’ treatment protocol has been peer reviewed by international medical journals and sponsored by one of the largest stem cell researchers in the world, Beike Biotechnology.
Dr. Mesples’ treatment protocol of transplanting autologous bone marrow stem cells, without immuno suppression, into chronic type 1 diabetic patients, is a treatment that drastically improves the health and quality of life of the diabetic patient. This treatment manages to recover the function of the injured pancreatic islet cells and increase the production of insulin in 75% of patients within 4 months after treatment. Allowing treated patients to achieve metabolic stabilization, requiring lower doses of insulin or becoming insulin free for 3 to 5 years. The treatment does not cause lesions in the bone marrow, which recovers quickly after transplantation, so the treatment can be repeated as many times as necessary to continue or improve metabolic stabilization.
Currently, there is no approved diabetes treatment like this available in the US. Through his company Stem Cell Bahamas, Dr. Mesples is conducting a clinical trial at Doctors Hospital - Bahamas Medical Center in Nassau, The Bahamas. This trial is open to any type 1 diabetic and chronic type 2 diabetic worldwide.
The Science of Stem Cell Therapy
When a diabetic’s adult stem cells that have been treated using the Mesples’ process are injected into the diabetic, the treated stem cells are directed to the damaged pancreas using chemokines. The stem cells that migrate through the action of chemokines biologically reach the designated pancreas and secrete mediators. This action causes local stem cell activation, differentiation, and the damaged cells in the pancreas are transformed by the human body into healthy islet cells.
Stem cells are special cells in our body that can replicate and differentiate – meaning they can transform into a myriad of healthy functioning cells found in your body. Dr. Mesples’ treatment protocol uses a diabetic’s adult stem cells that already exist in their bone marrow are small protein molecules that act as chemattractants, leading the migration of treated stem cells to the damaged pancreas.
Through his research Dr. Mesples has confirmed that adult stem cells can provide a replacement source of cells to treat serious diseases. This ultimately means that virtually any disease that results in cellular and tissue destruction can potentially be replaced by adult stem cells.
History of Dr. Mesples Diabetes Treatment Protocol
Dr. Mesples research into diabetes treatment began in Argentina. There he created a diabetes treatment that involved infusing a diabetic’s own stem cells, collected from the diabetic’s bone marrow, into the pancreatic system to stimulate the regrowth of islet cells in the pancreas. The treatment was non invasive and did not utilize autoimmune suppressant drugs. In 2005 the Argentinian Government authorized Dr. Mesples to conduct clinical trials, using his new treatment protocol. The results were very promising. There were no adverse side effects or health events. The treatment was shown to improve blood glucose control, insulin secretion, reduce insulin injection requirements, and not require autoimmune suppressant drugs. The new treatment protocol showed a strong potential to become a primary or supplemental treatment for type 1 diabetes sufferers, improving their quality of life, avoiding complications of diabetes such as kidney failure, blindness, and lower limb neurological damage.
The results of the Argentinian clinical trials for Dr. Mesples new diabetes treatment protocol attracted the attention of the largest biotechnical company in China, Beike Biotechnology. Beike is a world leader in stem cell research and medical applications. Over the next decade Dr. Mesples conducted research and clinical trials in China, substantiating his original results and improving on the treatment process.
Dr. Mesples and his team at Stem Cell Bahamas have begun a clinical trial at the Bahamas Medial Clinic. The current trial was approved by the government’s National Stem Cell Committee and confirmed for efficacy via an Independent Review Board Opinion by the University of Miami Medical Stem Cell Division. (The Bahamas clinical trial is similar to a Phase 3 FDA trial in the US ) The trial is being conducted at the Bahamas Medical Center, owned by Doctor’s Hospital Health Systems of The Bahamas. Doctors Hospital is accredited by the Joint Commission International (JCI).
JCI is the international arm of the U.S.-based Joint Commission on the Accreditation of Healthcare Organizations (JCAHO); the same body that certifies more than 21,000 hospitals in the United States. Fewer than 850 hospitals outside of the United States have earned the accreditation and Doctors Hospital remains one of only two acute care hospitals in the Caribbean region to be recognized for its consistent adherence to international quality standards.
The new trial in the Bahamas will utilize a larger patient base and develop a standard protocol for the stem cell re-transplantation process. At the conclusion of the Bahamas’ clinical trial, Dr. Mesples will apply for a marketing permit from the Bahamian Government to begin selling his treatment to medical practitioners that treat diabetic patients from around the world.
Historical Clinical Trial Results for Dr. Mesples’ Treatment Protocol
Within the last three years, 3 meta-analyzes were published in medical journals concerning the transplantation of different types of cells and techniques to treat type 1 diabetics. This analysis included over 1500 patients from around the world (outside the US).
The meta-analyzes showed that adult hematopoietic stem cells are the ones that show the best results in terms of the peptide c elevation and the decrease in daily insulin use. Dr. Mesples came to these same conclusions in his research 10 years ago.
The complete clinical results of Dr. Mesples’ clinical trials are not provided here because they are lengthy and very technical. The complete research documentation (clinical results) provided to the Argentinian Government about Dr. Mesples’ initial clinical trials, research and clinical trial results with Beike Biotechnology, and similar information provided to the National Stem Cell Committee of the Bahamian Government is available to qualified recipients after signing a Non Disclosure Non Circumvention Agreement.
WHY IS DR. MESPLES’ DIABETES TREATMENT SO IMPORTANT IN THE UNITED STATES?
Medical research and treatment protocols of diseases in the United States are a multi billion dollar industry. By law all new drugs and medical treatments must be approved by the Food and Drug Administration (FDA). This process is arduous, can take 10 years or more, and is very expensive. The FDA approval process has become a typical government bureaucracy that is controlled by the largest drug companies, medical research facilities, and political philanthropic organizations through political persuasion. Although factions of the medical industrial complex have noble objectives to cure diseases, it rarely happens. Diabetes is a classic example.
A diabetic can live a long life with diabetes if they take insulin correctly and do a reasonable job of controlling their blood sugar levels. However, the longer a person has diabetes the probability of kidney failure, eye problems, and nerve damage to lower extremities increase significantly. This is the perfect disease for the medical industrial complex. Drug companies make billions selling insulin and blood sugar testing equipment. Philanthropic entities like the Juvenile Diabetes Research Foundation (JDRF) raise tens of millions of dollars a year from well meaning donors for diabetes research and then provide grants to medical research facilities to find a cure. JDRF has been doing that for over 30 years and are no closer to a cure than when they started. Medical research about diabetes is fragmented and old concepts are rarely challenged. When Global Cell Med USA contacted JDRF about discussing Dr. Mesples treatment protocol, they declined. There are no FDA approved medical treatments for diabetes using stem cells and no immuno suppression drugs available in the US market.
Dr.Mesples’ research in Argentina was not hampered by the bureaucracy and financial agendas inherent in the US. Thus he was able to create a treatment for diabetes using stem cells that does not require autoimmune suppressant drugs. Do to the successful results of Dr. Mesples’ previous clinical trials, Global Cell Med USA should be able to enter the FDA approval process as a mature Phase 3 stem cell treatment clinical trial, eliminating years of clinical trials and millions of dollars in expenses. As soon as the minimum number of patients are treated and the results approved by the FDA, Global Cell Med USA could have a treatment for diabetes on the market in the US in less than 2 years that is non invasive, economical, and effective.
Global Cell Med USA is an affiliated company of Stem Cell Bahamas, which desires to expand into the United States, the largest market for type 1 diabetes in North America with over 3 million diagnosed sufferers.
The objectives of Global Cell Med USA are:
To help heal type 1 diabetics, utilizing Dr. Mesples’ diabetes treatment protocol in the United States.
The first step is to obtain a New Investigative Drug Number (IND) from the US Food & Drug Administration and enter their approval process at Phase 3. This is the last clinical phase before the stem cell treatment is approved for mass marketing as a medical practice.
The next step is to obtain an Independent Review Board Opinion (IBR) on the efficacy of Dr. Mesples’ treatment protocol for treating type 1 diabetics.
Then Global Cell Med USA will be in a position to contract with hospitals and other diabetic treatment facilities to use Dr. Mesples’ treatment protocol, expanding its Phase 3 clinical trials for new stem cell treatments.
Once the Phase 3 clinical trials results have been examined and approved by the FDA, Global Cell Med USA will obtain a permit to market Dr. Mesples’ treatment protocol to qualified medical practitioners that treat diabetes in the US.
Global Cell Med USA intents to present to the FDA the clinical trial data from Argentina, China, and Bahamas and use that data to get credit for completing Phases 1 and 2 in the FDA’s new stem cell treatment approval process. If approved the US clinical trial will begin as a final Phase 3 trial.
Once Global Cell Med USA has obtained an IND from the FDA, it will partner with medical providers in the US that qualify to conduct clinical trials for type 1 diabetes treatment. These initial partnerships will be located in population centers so they can service as many type 1 diabetics as possible.
Global Cell Med USA will use the clinical trial results from the Bahamas in combination with the results from Phase 3 clinical trials in the US and partition the FDA to shorten the number of patient requirements for a Phase 3 clinical trial. If successful Global Cell Med USA will substantially shorten the timeline for applying for a marketing permit to sell Dr. Mesples stem cell treatment to a large number medical practitioners that treat diabetics. This would be the first a non evasive, economical, and effective treatment for type 1 diabetes that can help heal millions of type 1 diabetics within the United States.