Regulatory Issues in Regenerative Medicine

Regenerative aesthetic medicine (RAM) is becoming an increasing popular addition to dermatologists’ practices. Its evolving menu of procedures and applicability in addressing such key concerns as hair restoration, wound healing, scar reduction and anti-aging/rejuvenation address patient demand for natural-looking and longer lasting results.

Mastering the range of modalities is just part of the learning curve in maximizing RAM’s potential. Understanding and complying with relevant regulatory issues is also essential, William P. Weschler, MD, pointed out in his presentation on the topic at Maui Derm Live. The in-person dermatology continuing medical education (CME) conference in Hawaii was held concurrently with Maui Derm Connect, a virtual CME conference, in January.¹ Dermatology Times® features his remarks and comments from an interview in an overview on regenerative medicine to be featured in its April 2021 edition.

Werschler, an assistant clinical professor at the University of Washington in Spokane, a founding member of Spokane Dermatology Clinic and Werschler Aesthetics, and a Dermatology Times® editorial advisory board member, cautioned that the premise that, as an autologous procedure, RAM is not subject to FDA oversight is false.

The 21st Century Cures Act signed into law in 2016 addressed RAM. It was designed to accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently, and it gave the FDA statutory authority over aspects of RAM by establishing the Regenerative Medicine Advance Therapy program.

But that is just one of the regulatory issues to consider. “RAM procedures and materials do not undergo the traditional process of FDA review and approval as do the drugs, biologics, and devices that we use,” said Werschler. “However, there are FDA guidelines that create guardrails around the conduct of regenerative medicine. Anyone who is using platelet rich plasma (PRP) or stem cells should be fully aware of these rules so that they do not run afoul of the FDA.”

The equipment used in the preparation and administration of the materials—such as the centrifuges used to prepare PRP or the needles, tubing, and syringes used for injection, etc—are FDA-cleared devices, usually class 1 or 2. To date, the FDA has not officially “approved” the autologous use of ADSC or PRP as a medical procedure.

Additionally, under the Public Health Service Act (PHSA) section 361, the FDA has the authority to regulate procedures that may spread communicable diseases. This is intended to minimize infectious disease risks associated with the use of human cells, tissues, and cell- and tissue-based products (HCT/P). Section 361 applies to regenerative aesthetics when the HCT/P is “minimally manipulated and for homologous use only and does not involve the combination of the cells or tissues with another article except for water.”

Section 351of the PHSA is of particular interest to dermatologists who want to offer RAM because it gives the FDA oversight on the use of any HCT/P that are more than minimally manipulated. Essentially, if the regenerative technique does not meet the criteria of section 361, it falls under section 351, which requires a biologics license application.

“When these autologous products are manipulated beyond their original structure and function, they move from just beyond FDA purview to essentially a clinical investigation with institutional review board [IRB] oversight,” Werschler explained. “Physicians are not prohibited from using these techniques, but those who wish to do so must first describe their intent by submitting a study protocol and obtaining IRB approval for the study before they proceed.

“That’s how we learn, through the scientific method,” Werschler said.