The day one of our stem cell sector companies gains FDA approval for a directly applied therapy the result may well be the same for stem cells as that famous day in 1906 was for football. Saint Louis University's Bradbury Robinson tossed the first forward pass to teammate Jack Schneider and created the modern game. For stem cells that day may not be far away. Our money is on Osiris Therapeutics to be the first to gain FDA approval. Osiris's Prochymal has a good chance to be the stem cell arena's first forward pass.
Prochymal is a patented formulation of human mesenchymal stem cells found in bone marrow. it modulates the inflammatory response by decreasing the production of pro-inflammatory cytokines and increasing levels of anti-inflammatory cytokines. Prochymal stem cells have demonstrated an ability to migrate to sites of inflammation and tissue damage and to facilitate the repair process when they get there.
In cardiology alone, the global market for stem cells is projected to reach about $3.5 billion by 2012 according to a recent industry report by RI Technologies. And this is just one potential therapeutic use. Some companies in this sector have a very bright future. Achieving that future is not easy, however. Prochymal is in phase I trials for acute myocardial infarction.
Osiris has taken an interesting approach to gaining FDA approval, a difficult benchmark to achieve in an entirely new and controversial field of medicine. The company has developed a product with broad possible application and then chosen diseases for clinical testing that the FDA will approve because the patients entering trials either will die or be subjected to repeated operations if no solution is found. Two diseases that fit one or both of these criteria are Crohn's disease and Graft versus Host disease. Prochymal is entering Phase III trials in each of these.
Osiris's concentration on bone marrow derived stem cells versus embryonic or adipose derived stem cell research will also boost the blood derived stem cell arena as a choice for further research, assuming the company is the first to gain approval. Bets on other stem cell sources have been made by some in the sector. FDA approval for a product based on bone marrow derived cells would reinforce the regenerative value of such cells. 'Reinforce' because Bone marrow derived stem cells have been used successfully as part of a cure for various blood cancers for several decades.
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