Federal Courts Reaffirm FDA Authority Over Fat-Derived Stem Cell Treatments: SVF Classified as a Drug, Delivering Legal Setback to Stem Cell Clinics
?? Lance Liberti, MBA
I Help ??Physicians & ?? Healthcare Clinics ?? Increase Patient Outcomes & ?? Add More Revenue, Without ?? Drugs By Adding Office-Based ?? Injection Procedures to Their Practice [email protected]
A federal court has once again ruled in favor of the FDA, affirming that fat-derived stem cell treatments, specifically stromal vascular fraction (SVF), are classified as a "drug" and must be regulated accordingly. This decision by the 9th Circuit Court of Appeals confirms that SVF, a mixture of stem cells and other cellular material derived from patients' fat cells, is not exempt from FDA oversight under the "same surgical procedure" exception.
Key Court Rulings on SVF Classification
The 9th Circuit ruling strengthens the FDA's position, allowing it to regulate SVF-based therapies across the U.S. Paul Knoepfler, PhD, a stem cell expert at the University of California Davis, highlighted the importance of this ruling in his blog. He noted that in states like Florida, some patients who underwent SVF treatments experienced severe side effects, including vision loss, underscoring the need for regulatory oversight.
This legal decision is the result of an FDA lawsuit against the California Stem Cell Treatment Center and its affiliated Cell Surgical Network over their use of SVF. Initially, a federal judge ruled in favor of the clinic in 2022, determining that the treatments were not subject to FDA regulation.?However, following an FDA appeal, the court reversed the decision in favor of the FDA.
Legal Precedent and Broader Implications
This ruling mirrors the outcome of another significant FDA lawsuit against U.S. Stem Cell Clinic in Florida. In that case, the court ruled that SVF was a drug in 2019, and the clinic's appeal was also denied. These back-to-back rulings establish a clear legal precedent: SVF constitutes a drug under federal law and is subject to FDA regulation.
Knoepfler has referred to these rulings as some of the most critical FDA stem cell decisions in recent years. He further pointed out that in a related case, U.S. v. Regenerative Sciences, a different type of stem cell therapy called Regenexx-C involving mesenchymal stem cells from bone marrow was similarly classified as a drug due to additional processing before reinjection.5
Future of Stem Cell Clinics and FDA Actions
Despite this legal setback for clinics offering SVF treatments, some in the industry may focus on other forms of cell-based therapies, such as those derived from birth tissue, or FDA-cleared autologous therapies such as Platelet-Rich-Plasma (PRP).
Looking ahead, one of the key uncertainties is whether the case involving the California Stem Cell Treatment Center will be appealed to the Supreme Court. Meanwhile, the FDA may take more decisive actions against clinics offering unproven and unapproved cell-based therapies.
The California Stem Cell Treatment Center Case
The California Stem Cell Treatment Center, founded by Mark Berman, MD, and Elliot Lander, MD, operates two clinics in Beverly Hills and Rancho Mirage. The center offers investigational research treatments funded by patients, who pay out of pocket as insurance coverage is not accepted. Prices for these treatments range from $8,900 for a single session to $41,500 for a 12-treatment plan.
According to court documents, the clinic treats a wide range of conditions, including Alzheimer's, arthritis, cancer, multiple sclerosis, and erectile dysfunction, among others. The Cell Surgical Network, created by the center, includes other doctors who adopt its treatment protocols and purchase equipment for cell isolation.
This ruling marks a significant moment in the FDA's ongoing efforts to regulate stem cell clinics offering unapproved therapies. While the court's decision strengthens the FDA's authority over SVF treatments, the future landscape of the stem cell clinic industry may shift, with potential changes in the types of therapies offered. However, the FDA's regulatory framework will likely continue to evolve in response to these developments, ensuring patient safety remains a priority.
What About Alternative Therapies, such as Platelet Rich Plasma?
With all of the regulatory focus on stem cell therapies, the high cost associated with those procedures, as well as known and unknown risk factors, one has to ask if there is a better alternative therapy for the patient's present consideration. Contrary to unapproved stem cell therapies, there are many FDA-cleared devices for regenerative medical procedures such as Platelet-Rich-Plasma (PRP).
The FDA current position can be found at FDA 21CFR127115b. This document states the regulatory role and position stance of the FDA on blood products such as platelet-rich plasma. These products fall under the FDA Center for Biologic Evaluation and Research. This body is responsible for regulating human cells, tissues, and cellular and tissue-based products. Under their regulations, certain products such as PRP are exempt and therefore do not follow traditional regulatory pathways that include animal studies and clinical trials.6
The PRP preparation systems on the market today with FDA clearance are 510K cleared. This means that the kit is substantially equivalent to a currently marketed device. PRP was initially approved to mix with bone graft material to enhance healing in orthopedic procedures. The use of PRP outside of this application is considered “off-label use”. Clinicians are free to use a product off-label if certain responsibilities are met. In the practice of medicine, clinicians have the responsibility to be well-informed about the product and base its use on firm scientific rationale and sound medical evidence, and to maintain proper records of the use. This is the exempted use for the many varied procedures and protocols of platelet-rich plasma today.
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It should be noted there is some concern about the method of activation of PRP but to date, the FDA has not attempted to regulate activated PRP.
Juventix Regenerative Medical is an industry leader in the regenerative medical field. Our Platelet Rich Plasma Kits are FDA-cleared and designed for safety, sterility, and effectiveness. Our kits are scientifically manufactured to provide a platelet concentrate, devoid of red blood cells with a minimum number of leukocytes that are critical to the regenerative process.
Our kits are 510K cleared by the FDA. Juventix Regenerative Medical has never received any warning letters from the FDA in the history of the company. Finally, any claims that are made for the use or applications of our PRP or PRF products are based on current published scientific studies, of which there are presently more than 22,686 available on PubMed and other scientific sites readily available on the web.
Juventix Regenerative Medical is a company trusted by professionals in the regenerative community. To further introduce professionals to the quality of Juventix’s products, the company is offering a sample PRP kit at a special price of $24.99. This limited-time offer allows practitioners to experience firsthand the effectiveness of Juventix state-of-the-art PRP kits. Interested parties can request a sample by emailing [email protected] with the subject line "SAMPLE" or by visiting https://juventix.com/sample-page/.
For more information about Juventix Regenerative Medical and its offerings, visit www.Juventix.com or call (866) 693-4PRP.
About Juventix Regenerative Medical LLC:
Juventix Regenerative Medical LLC is dedicated to innovation in non-surgical alternatives for combating the problems of aging. Founded by Lance Liberti over a decade ago, the company has been at the forefront of developing simple, clinically effective, and cost-effective PRP processing kits. Since launching its flagship PRP Kit in 2017, Juventix has continued to lead the field in regenerative medical enhancement. The company also hosts advanced clinical training symposiums in collaboration with renowned organizations such as the USF Health Center for Advanced Medical Learning and Simulation (CAMLS). To learn more about Juventix Regenerative Medical, please visit www.Juventix.com.
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