Lost amidst the Adult stem cell company Osiris’ latest press release announcing their 1rst quarter results for 2009, was a revelation that revealed that their “off the shelf” stem cell product, Prochymal, was given approval by the FDA to be used as a stem cell treatment and therapy for Graft Vs Host Disease (GVHD) in children.
Adult Stem Cells for GVHD
In May 2008, Osiris announced that Prochymal could be used under the FDA’s expanded access treatment program (EATP) which would make the Adult Stem Cell treatment available to children between the ages of 2 months and 17 years old to receive the stem cell therapy for severe cases of GVHD. This expanded access treatment program enables Osiris to sell their Prochymal ‘at cost” to children with life threatening GVHD.
From the stem cell article:
Most of the patients have failed two to three prior treatment options and are using Prochymal as a last resort. But so far the results are extremely encouraging, with 100 day survival at approximately 60%. In early December 2008, Osiris received approval from Health Canada to allow the expanded access for Prochymal use in children in Canada.
Osiris is currently expanding its resources to be able to offer Prochymal through the EATP to adults in the U.S.
Expanding its resources to offer Prochymal? Why do you have to “expand resources” for a product that is already made? Is that code for “begging the FDA”? But I digress. This is really good news for children who may very well need stem cell treatment now and can’t afford to wait for the clinical data to come in. Of course that begs the question, why not make it available to adults too? To not be able to offer an 18 year old suffering from Graft Vs Host Disease an Adult Stem Cell therapy (with no side effects) that may save his life seems ludicrous to me.
original post by Don Margolis