What constitutes a new drug? We all have stem cells that live inside of us, are they tissue or drugs? It makes a big difference in the availability of stem cell treatments for millions of Americans. If the adult stem cells that live inside us can be minimally culture expanded like fertility clinics do everyday, then safe stem cell therapy can be quickly available to the masses. The FDA’s position has been that this type of minimal culture work means a new drug is being created, yet does that make sense? While there are many things that can be done to the patent’s own stem cells to make them drugs (insert new genes, grow them for extended periods, make significant changes to their make-up), growing them for short periods like the Regenexx procedure doesn’t qualify. For more on the issue, see the SafeStemCells patient movement of the American Stem Cell Therapy Association. These outfits have stated that adult stem cells aren’t drugs, they are tissue that should be available to physicians as tools to safely treat patients under strict guidelines run by physician groups.
Tags: centeno, doctor, fda, regenerex, regenerxx, regenex, regenexx, stem cell, stem cells
