FDA Issues Regenerative Medicine Policy Framework

Patients’ Rights to Use Autologous Cells Largely Ignored

Sunrise, FL – Nov. 20, 2017 – As Americans are becoming more aware of scientific advancements empowering them with options to utilize regenerative medicine by harvesting their own stem cells for therapeutic treatment, the Food and Drug Administration is simultaneously issuing guidelines that could limit the availability of this more holistic, cost-effective approach in favor of more expensive, off-the- shelf therapies which are marketed by pharmaceutical companies using manipulated stem cells from other donors, according to the network of physicians and scientists at The Academy of Regenerative Practices (ARP).

Instead of laying a practical and sensible foundation that encompasses all regenerative therapies, the FDA chose to implement a policy that favors stem cell therapies developed by drug companies, sidestepping medical in-clinic procedures using stem cells harvested from a patient’s own tissue (autologous cells).

“The track record of regenerative therapy using autologus stem cell procedures speaks for itself, and patients have a right to informed consent which will help them decide to use these therapies,” said Mark Berman, MD, cosmetic surgeon, faculty and board member of ARP. “ARP supports the rights of physicians to offer these lower-risk therapies, harnessing a more holistic approach with very few reports of complications.”

The autologous techniques often include the collection of stromal vascular fraction from adipose tissue for use in degenerative conditions such as cardiac, osteopathic and autoimmune conditions. These in-clinic procedures are performed by physicians and practitioners that are trained in autologous stem cell therapies, many of which have been documented in the scientific literature with a strong safety profile.

Because these procedures are simply redistributing an individual’s own stem cells to diseased or damaged tissues in the body, it is the opinion of ARP and other patient rights’ advocates that these procedures should not be regulated the same way as drugs, which generally require hundreds of millions of dollars to complete clinical trials. Instead of regulating these more holistic procedures accordingly in order to make the treatments more widely accepted and practiced, the FDA continues to stall its regulatory progress on the issue and is instead focusing on regulating costly, more complex procedures.

“By ignoring the sophistication of the autologous stem cell therapies, the FDA is avoiding the important advancement autologous stem cell treatments have brought to regenerative medicine,” said Barbara Hanson, patient advocate for Stem Cell Pioneers, a patient advocacy group, and a board member of ARP. “Regulations should reflect lower risk when a patient uses his or her own cells and tissues for treatment. The FDA — if it regulates our own stem cells and tissues as drugs, which would require clinical trials before autologous stem cells can be reintroduced into the patient’s body — will do more harm than good for patients who should not have to suffer for a regulatory policy that makes no sense.”

This would limit regenerative medicine to drug companies who are bringing forward expensive, off-the- shelf cell and gene therapies for $475k, versus $5k-$12k for in-clinic, autologous stem cell treatments.

“Since doctors, clinics and physicians currently administering autologous stem cell treatments already are seeing the benefit of these regenerative therapies, they know first hand the importance of access to these treatments, which is why market demand is increasing so rapidly,” said Dr. Kristin Comella, President of ARP and Chief Scientific Officer of U.S. Stem Cell, Inc. “Market demand will drive this industry, and patients will seek autologous regenerative therapy in or outside the United States. In light of our explosive, opioid/pain management crisis, it seems now is the time to expand access to effective, regenerative therapy, not the other way around.”

The ARP is dedicated to education of medical practitioners in the latest cellular medicine techniques and therapies, as well as the rights of medical practitioners to practice regenerative medicine and provide life altering autologous cell therapies to their patients. Because we provide a forum for multiple disciplines to integrate and learn the most advance regenerative clinical applications, we are dedicated to monitoring regulations that impact the rights of physicians to offer therapies to their patients and, as such, might limit the rights of patients to access natural healing using their own cells. Our members are currently using stem cell techniques in the clinic in a safe and responsible way which is in line with the FDA’s risk based approach with safety as the highest concern.