Osiris Therapeutics Inc. has announced that Canadian regulators have approved its stem cell application called Prochymal, a treatment for the deadly side effect of bone marrow transplants.
The company said Health Canada approved Prochymal to be used to treat graft vs. host disease, a condition where transplanted bone marrow cells attack patient’s body. Prochymal is approved to be used in children who do not respond to steroid therapy.
Osiris is still conducting clinical trials of Prochymal to gain full marketing approval, but the drug has been granted conditional approval due to the lack of effective therapies for graft vs. host disease. Osiris needs to run morel studies to confirm the treatment works.
The marketing of Prochymal is yet to be approved in the U.S., but patients can receive the treatment under certain conditions. The Food and Drug Administration authorizes the use of Prochymal to treat adults and children with graft vs. host disease when steroids have been ineffective.
Osiris, in Columbia, Md., had been developing Prochymal and a second stem cell application, Chondrogen, in partnership with Genzyme, a part of French drug maker Sanofi. But in February 2012 Sanofi said it had stopped late-stage testing of Prochymal. Osiris believes Sanofi has ended the collaboration and that it should regain all rights to Prochymal. Osiris said Sanofi disagrees and that the companies are now discussing their status.
Prochymal is also being researched as a treatment for Crohn’s disease and other medical conditions.
At Angeles Health in Mexico patient-funded clinical trials of stem cell application for COPD (Chronic Obstructive Pulmonary Disease) and heart conditions such as congestive heart failure are being carried out. Please contact us if you are interested in taking part. We also offer trials for other medical conditions.