Osiris Therapeutics announced that it has been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for Prochymal as a treatment for type 1 diabetes mellitus. The FDA instituted the Orphan Drug Act to promote the development of treatments for underserved patient populations. To be eligible for Orphan Drug designation, the treatment must target a disease that affects fewer than 200,000 new patients per year in the United States.
NEW YORK, April 27, 2010 - The Juvenile Diabetes Research Foundation announced today that it is partnering with Living Cell Technologies (LCT), a New Zealand-based biotechnology company focused on developing cell based therapeutics, in a Phase II clinical trial to study the safety and effectiveness of transplanting encapsulated insulin-producing cells from pigs as a treatment for type 1 diabetes with significant hypoglycemia unawareness.
A hormone responsible for the body's stress response is also linked to the growth of insulin-producing cells in the pancreas, according to JDRF- funded researchers at the Salk Institute for Biological Studies in California. The findings are the latest advances to underscore the potential for regeneration as a key component of a possible cure for type 1 diabetes.
How careful should healthcare workers and patients be in describing a total remission of diabetes as a "cure?" That's a question that has taken on increasing urgency in the wake of reports about dramatic reversals of type 2 symptoms after gastric bypass surgery and the cessation of symptoms in people with type 1 diabetes after pancreatic islet replacement. To answer it, a group of endocrinologists met earlier this year to come up with descriptions and definitions that accurately describe what happens when people with diabetes experience a reversal of symptoms.
"Medical miracles do not happen simply by accident," said President Obama, as he signed an executive order lifting the ban on federally funded embryonic stem cell research. The Juvenile Diabetes Research Foundation (JDRF) is celebrating President Obama's new policy. They recently released this statement by Mary Tyler Moore, the International Chairman of the JDRF:
Nearly every time that I mention islet transplantation in a conversation about diabetes, the person I'm with responds with a sniff that it's never going to work because of the immune suppression problem.
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