Osiris Therapeutics is developing Prochymal in partnership with the Juvenile Diabetes Research Foundation (JDRF) as a treatment for patients with newly diagnosed type 1 diabetes mellitus.
Prochymal, a formulation of adult mesenchymal stem cells (MSC) designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation, is currently being evaluated in a double-blind, placebo-controlled Phase II clinical trial for type 1 diabetes.
Reportedly, a Phase II trial is evaluating the safety and efficacy of Prochymal in preserving insulin production in patients 12 to 35 years old recently diagnosed with type 1 diabetes. The 62 patient, double-blind, placebo-controlled trial is being conducted at 20 medical centers across the US.
Prochymal has been granted Fast Track status by the FDA for GvHD and Crohn’s disease, and is the first stem cell product to receive FDA expanded access approval, making the product available now to patients with GvHD. Prochymal also obtained orphan drug status for GvHD and type 1 diabetes from the FDA as well as orphan drug status for GvHD from the European Medicines Agency.