Prochymal is a stem cell therapy made by Osiris Therapeutics. It is the first stem cell therapy approved by Canada. It is also the first therapy approved by Canada for acute graft-vs-host disease (GvHD).
It is an allogenic stem therapy based on mesenchymal stem cells (MSCs) derived from the bone marrow of adult donors. MSCs are purified from the marrow, cultured and packaged, with up to 10,000 doses derived from a single donor. The doses are stored frozen until needed.
Approvals and indications
In May 2012 Health Canada approved the use of Prochymal for the management of acute GvHD in children who are unresponsive to steroids, with the approval conditional upon further trials being conducted.
Preliminary results of a phase III trial for GvHD were released in Sept 2009.
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