What are the top cosmetic procedures utilizing stem cells today?
Dr. Allan Wu: Cell assisted lipotransfer (CAL) for various forms of tissue augmentation has taken off like wild-fire in Japan and the rest of the regulatory world that does not forbid the procedure. The procedure itself is almost a decade old, and who would have thought adding the stromal vascular fraction (which contains ADSC) would have such a tremendous impact on free fat grafting? Dr. Kotaro Yoshimura, the inventor of the procedure, and other colleagues outside of Japan, has had tremendous results with breast, hand and facial augmentation. Though breast augmentation seems like a frivolous application of science, the cross-translational knowledge and skill is reaping rewards for our colleagues in wound care and cancer reconstructive surgery, thus creating unanticipated novel “spinoff” therapies. To date the world medical literature has not reported a single teratoma or cancer as a result of appropriate CAL use.
It is important to note that as other countries continue to innovate and develop CAL and related techniques, the United States could find themselves in a predicament in which novel stem cell therapies could belong to foreign countries with a different regulatory philosophy. Ironic too since the U.S. has significantly funded basic sciences research in regenerative medicine, and a horrible shame in that (even if the regulatory climate were to change over night) we may find ourselves eventually “locked out” due to a growing international patent thicket. In short, our government needs a coherent, consistent and pro-active policy for regenerative medicine especially if we plan on using regenerative solutions to combat the rising cost of domestic health care and also support a promising new industry that will have direct material impact upon the American economy.
So hypothetically speaking (and to address your “course correction” in question #1), if I were POTUS or the FDA, I would find a way to at least allow SVF use in the form of CAL, but require regulatory oversight. In this way clinicians lacking a major research budget would be able to operate without a costly IND. In exchange all clinicians would mandatorily submit close follow up data to an independent national registry to monitor the safety of the procedure in much the same way our colleagues in infertility and transplant medicine do already. Should a negative pattern develop, the procedure can immediately be placed on hold until further study is done to determine necessary corrections in cooperation with the FDA.