Someone Else’s Stem Cells-Prochymal in Flames

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Osiris announced the results of their phase III clinical trials yesterday for Prochymal, their stem cells in a vial approach to Graft vs. Host Disease (GVHD).  It was a spectacular failure.  This comes on the heels of Geron’s suspended trial due to safety fears (embryonic stem cells in a vial for spinal cord injury) and Osiris’ negative early results in Crohn’s disease (stem cells in a vial).  See the trend?  As I have blogged in past posts, stem cells in a vial spell trouble. My prediction is that Chondrogen will fail as well (Osiris’ stem cells in a vial for knee cartilage).  Why?  These cells are not invisible to the host’s immune system as previously thought, so they are likely  getting chewed up by that immune system before thay have a chance to act.  What are the implications?  Hundreds of millions wasted in clinical trails.  My prediction is that the big picture is that culture expanded, autologous stem cells will be the only game in town for years to come.  They will likely be superseded in the 7-10 year time frame by Induced Pluripotent Adult stem cells, but the risk profile for IPS cells will be much higher (but their healing potential is likely greater as well).

Stem cells in a vial are a great big pharma biz plan, if only it actually worked…

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Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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