FDA Fast-Track clearance expedites stem cell therapy
Osiris Therapeutics, Inc. currently has two product candidates in clinical trials for a number of indications. Prochymal, an intravenously administered formulation of mesenchymal stem cells, is being evaluated in Phase III clinical trials for three indications, including acute and steroid refractory graft versus host disease (GvHD) and also Crohn's disease. It is the only stem cell therapeutic currently designated by FDA as both an Orphan Drug and Fast Track product.
Prochymal is also being evaluated in Phase II clinical trials for the repair of heart tissue following a heart attack, the protection of pancreatic islet cells in patients with type 1 diabetes, and the repair of lung tissue in patients with chronic obstructive pulmonary disease.
Osiris is also evaluating Chondrogen, an injectable formulation of mesenchymal stem cells, for arthritis in the knee.
- GvHD
- Phase III Steroid-Refractory Acute GvHD - ENROLLMENT COMPLETE
- Phase III Newly Diagnosed Acute GvHD - ENROLLMENT COMPLETE
- Pediatric Expanded Access Program - ACCEPTING PATIENTS
- Crohn’s Disease
- Phase III Trial - PREPARING TO RESUME ENROLLMENT
- Type 1 Diabetes
- Phase II Trial - ENROLLMENT COMPLETE
- Cardiac