Good question...wish I knew...but the 10K stated that the FDA IND for knee osteo was filed...I think this this means that the FDA has given them approval for the clinical trials and research...so, this is promising:) FYI, the FDA has approved other types and uses of stem cells...can't tell you what exactly, can't recall, just remember noting that they were approved by the FDA...so, there is should be no reason if the appropriate steps are taken, that the Intellicell tech will not be approved. The Dr. has to state all possibilities in the 10K as a disclaimer...as many other companies 10K's will commonly have similar disclaimers for liability reasons.