Prochymal, the adult stem cell product derived from bone marrow and developed by Osiris Therapeutics, is currently in clinical trials for the treatment of type I diabetes. The double-blind, placebo-controlled, multi-site Phase II clinical trials have a target enrollment of 60 patients, each one of whom will receive 3 infusions over a period of 2 months.
Prochymal has been shown to protect the pancreas from the type of autoimmune attack that characterizes type I diabetes, thereby allowing the natural production of insulin. Patients in the trial have been able to reduce the amount of externally administered and prescribed insulin as their pancreas begin producing its own insulin.
According to Dr. Aaron Vinik of the U.S., "This is a very exciting discovery. When people get told they have diabetes, it comes as a tremendous shock. They have to live with having to take insulin injections for the rest of their lives. In the future, we will have a cure that will stop the disease in its tracks."
Prochymal is a proprietary adult stem cell product, the active ingredient in which is mesenchymal stem cells (MSCs) that are derived from healthy adult volunteer donors and formulated for intravenous infusion. Embryonic, fetal, and animal tissue are not involved. Prochymal has already been tested in over 1,000 patients in previous clinical trials with no adverse side effects.
In addition to these Phase II clinical trials for type I diabetes, Prochymal is also currently in Phase III clinical trials for graft-versus-host disease (GvHD), Crohn’s disease, and it is being developed for the repair of cardiac tissue following a heart attack as well as for the repair of lung tissue in patients with chronic obstructive pulmonary disease (COPD). Prochymal is the only stem cell therapeutic product currently designated both by the FDA and by the European Medicines Agency as both an Orphan Drug and as a Fast Track product. Osiris is also developing another adult stem cell product, Chondrogen, which is currently in clinical trials for the treatment of osteoarthritis of the knee.
A leader in adult stem cell therapies, Osiris Therapeutics is focused on the development of products for the treatment of inflammatory, orthopedic and cardiovascular diseases. In November of last year, Osiris formed a strategic alliance with the biotech company Genzyme that was valued at over $1.3 billion. In 2007, the two companies were awarded a $224.7 million contract from the U.S. Department of Defense for the development of Prochymal in the treatment of radiation sickness. (Please see the related news article on this website, entitled, "Genzyme and Osiris Form Adult Stem Cell Mega-Partnership", dated November 5, 2008).