Legislative Updates on Stem Cell Therapies
Earlier in the year, the FDA scheduled a hearing at their center in Silver Spring, MD, just outside of Washington, D.C., with regards to the ongoing use of Stem Cell Therapies in the United States. This hearing was scheduled for today, April 13, 2016. Because of multiple warnings and innuendos by the FDA prior to this, the scheduled hearing elicited concerns by all physicians currently involved with Stem Cell Therapies. Myself, including Dr. Mark Berman of Beverly Hills, CA and Dr. Elliot Lander of Rancho Mirage, CA, Cofounders of Cell Surgical Network, had planned to attend this meeting as we have always maintained that our close compliance with the Cell Surgical Network Institutional Review Board adequately addressed the FDA’s concerns. About one month ago, the FDA postponed this hearing until after the presidential elections.
In addition, members of the U.S. Senate have proposed legislation which would rein in overzealous FDA proposals. The congressional rebuttals to the FDA was spearheaded by U.S. Senators Mark Kirk and Susan Collins with the introduction of the REGROW Act. U.S. Senator Mark Kirk said:
The REGROW Act contains legislation to establish a unique regulatory pathway tailored specifically for stem cell therapies which can reduce both the time and cost of developing and delivering safe and effective stem cell therapies to patients. “Regenerative medicine holds incredible potential for the future of health care in our country and around the world. Through the development of innovative therapies and products, regenerative medicine could one day fully heal damaged tissues and organs, providing needed cures for diseases and conditions that are untreatable today,” said U.S. Senator Susan Collins. Board Certified Physicians provide safe and effective adult adipose-derived stem cell therapy, a noninvasive procedure using an individual’s own stem cells to treat diseases such as Multiple Sclerosis, Parkinson’s, Alzheimer’s, Rheumatoid and Osteo Arthritis as well as a tremendous host of other diseases.”
For more detailed perusal of the REGROW Act, click here
The beginning of this turmoil began during the time of our first Cell Surgical Network symposium in October 2015. Since then, I have lectured at major conferences and symposiums in New Orleans, San Diego, Ft. Lauderdale, and Panama City, Panama. I was also one of the keynote speakers at the SelectBio Biofabrication and Bioprinting symposium in Boston, MA last month.
With the cooperation of major international researchers from some of the top institutions in the world, Dr. Paul Gaetenholm of Chalmers University, Sweden and I have already began preparing for our second annual Stem Cell Symposium. Our focus and research will be on, “3D Bioprinting for Healing on the Battlefield”. We will seek funding and participation by the United States Department of Defense, The Wounded Warriors, and other major military organizations. The date of our second annual symposium will be announced in the coming months.