The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the Agency and understand the regulatory framework. Will it work this time around? This blog article recaps how we got to this point.
Stem cell treatments have been gaining popularity globally. Research is progressing in this field, but it is not fast enough for some. There is a rise in stem cell treatments being offered for debilitating conditions such as Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and chronic obstructive pulmonary disease. However, there are many cases of unsubstantiated claims being made that are causing irreparable harm. For example, there is the notorious case of U.S. Stem Cell, who conducted a fee-for-service treatment in which stem cells derived from fat were injected into patients suffering from macular degeneration. All 3 patients lost all or most of their vision. Subsequent investigations showed that the clinic failed to establish and follow procedures to prevent microbial contamination and refused to permit entry for FDA to conduct an inspection. Despite a warning letter to U.S. Stem Cell in 2017, the company continued operations and stem cell treatments. Instead of correcting noted problems, the clinic stated that FDA did not have authority to regulate the treatment.
On June 3, 2019, a federal judge ruled that FDA is entitled to a permanent injunction against US Stem Cell, to force the company to halt procedures that isolate stem cells from fat and reinject them into the patient. Another lawsuit against the Cell Surgical Network is pending. It’s likely that this will impact businesses that use fat-based stem cell treatments and yet may also drive businesses to use other sources of stem cells in an individual, such as bone marrow or umbilical cord blood.
FDA has stipulated that the manner in which cells are collected, processed, and delivered place them under the regulatory category of a drug. FDA has been trying to encourage stem cell businesses to work with the Agency rather than become litigious. In 2017, FDA gave stem cell businesses a 3-year grace period to engage with FDA to understand how they might come into compliance, whether for investigational trials or premarket approval requirements. However, the rate for those offering human cells, tissues, and cellular- and tissue-based products, to come into compliance has been slower than expected. So, FDA is offering a temporary program for manufacturers to get quick, informal, non-binding assessment from FDA. “Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP)” intends to respond to inquiries that contain sufficient detail within 3 days of receipts. The program will be available until December 31, 2019.
The TRIP provides a preliminary, informal, non-binding assessment based on evaluation of the following information, where provided:
- The manufacturer of the product, if other than requester.
- The source of the product, including whether it is autologous or allogeneic.
- A clear, step by step description of how the product is processed from the time of recovery to the point of use.
- The specific way(s) the product is to be used and route of administration.
- Description of any device or apparatus (e.g., syringe) required to deliver the HCT/P to the recipient.
The opportunity to get feedback from FDA, and in such an expedited manner, is advantageous, but it is unclear how successful the program will be. There is indication that some stem cell clinics would rather move overseas to avoid regulation. That may accelerate when the grace period ends in November 2020.
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