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13 Jul 2016 10 Comments

Personalized Stem Cell Clinical Trials On Diabetes, May Bid Adieu To The Killer Epidemic Forever!

Several Boston area Hospitals have liaised with Harvard Stem Cell Institute & Biotech Semma Therapeutics to organize personalized Stem Cell-based therapy and clinical trials on patients suffering from Diabetes, to bid goodbye to the killer disease forever.

Diabetes is a metabolic disease that is usually associated with high levels of blood sugar over a prolonged period of time. The most common symptoms associated with diabetes include frequent urination, increased thirst and increased hunger. If left untreated diabetes may cause grave complications such as cardiovascular diseases, stroke, chronic kidney failure, foot ulcers, eye damage, coma etc.

Diabetes generally occurs due to failure or damage of the cells that produce insulin in the pancreas called Beta cells. Diabetes can be classified into 2 types: Type 1&2.

 Type I Diabetes is usually called the “Insulin dependent type of diabetes”, where the immune system of the patient attacks the pancreatic beta cells that produce insulin and the patient is dependent on an external source of insulin for a lifetime or on dead donor’s beta cells that are sourced and transplanted.

In the current scenario, the demand for cell transplant is surplus relative to the supply, so the patient suffers or if a donor is sourced the patient’s body may reject the donor’s beta cells.

In the case of Type 2 Diabetes, the condition usually begins with insulin resistance and the beta cells eventually fail to respond to insulin properly. The common causes of this type of diabetes are excess body weight, lack of exercise, genetic predisposition and off course intake of huge portions of simple sugars.

The incidence of diabetes in the world has risen from 108 million in 1980 to 422 million in 2014. With this colossal incidence of diabetes prevalent in the world, this stem cell therapy of hope has been welcomed with a titanic demand across the globe.

Several initiatives are aimed at manufacturing cell-derived therapies for Diabetes and this has escalated the demand for production of beta cells to a significant high, in the current years.

To outsmart the demand and conduct a safe clinical trial on volunteers a new program officially named “Boston Autologous Islet Replacement Program” has been initiated. This program not just offers sufficient high-quality beta cells to treat patients in the upcoming clinical trials; it can also prove the safety of the volunteers during the clinical trials.

This program intends to derive beta cells from the Volunteer’s own blood cells, thereby downsizing the risk of rejection. For the initial years, the researchers have intended to use the transplanted cells extracted from the pancreas of patients who got their pancreas removed due to pancreatitis or other conditions, to be used on volunteers. If this study proves effective and safe, doctors have decided to run the study afresh on diabetic patients.

In collaboration with this program, the clinicians at Brigham Women’s Hospital & Joslin Diabetes centre have recruited patients for this study. The experts at the Cancer Institute of Dana Farber have been assigned with the technique of extracting stem cells from the patient’s own blood cells and subjecting them as viable pluripotent stem cells that will evolve themselves as beta cells.

The transplant initiative will be performed by the doctors at Brigham in union with experts at Joslin, who will also monitor the progress of the patients. The entire program relies on the idea of Dr. Douglas Melton, Co-director of the Harvard stem cell Institute, who pioneered this concept of converting stem cells into beta cells.

Other researchers like Dr. Richard Lee, a Brigham cardiologist and a stem cell researcher also acclaimed that, this study will be a real breakthrough in science, forcing us to the point in technology where we can think about stem cell replacement, legitimately in the future.

This will be the most awaited advancement by both patients and medical faculty, as it represents a single cell production effort, which can succour them effortlessly in various treatments by application of induced pluripotent stem cell (iPSCs) into any clinical trial.

Additionally, this patient-specific treatment using iPSCs does not tangle them with any ethical issues that generally associate research & therapies with stem cells of an embryonic source.

This new proposal has won its consensus from “National Cell Manufacturing Consortium” announcing its own initiative of manufacturing a variety of cells, including iPS cells for treatment.

The entire study has been committed to be funded by the Stem Cell Institute; on the success of this initiative, more secure funding source will be needed for the organizers at Boston.

The challenge will lie in catering such therapies with iPSCs for trials in patients; this is contended with the question of feasibility due to funding constraints by many researchers. Though iPS cell treatments and its therapeutic efficacy were outlined a decade ago bringing it into patient based clinical trial was never a smooth road, due to the costs involved, explained a few scientists.

With the threat of Diabetes superseding all these barriers, the scientists and researchers, look forward to an ideal signal to take these trials to patients in need on a personalized note.

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