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Focus on Regulation

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell Treatment Center, alleging the treatments seriously harmed patients. Both lawsuits follow up on prior actions that FDA initiated against these clinics in the past year – a Warning Letter against US Stem Cell Clinic (as we reported here) and a court-ordered seizure of product in the possession of California Stem Cell Treatment Center (as we reported here). FDA Commissioner, Scott Gottlieb, M.D., said that while cell-based regenerative medicine holds significant medical opportunity, “[FDA] cannot allow unproven products that exploit the hope of patients and their loved ones.”  In line with the agency’s commitment to enhanced enforcement, Dr. Gottlieb suggested that further enforcement may be on the horizon, stating, “FDA will continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health…”.

FDA has focused on products that pose potential significant safety concerns, including stromal vascular fraction (SVF) therapies (stem cells derived from body fat and other regenerative cells) which are administered by injection. In these new complaints, FDA seeks an injunction against US Stem Cell Clinic, also naming its Chief Scientific Officer and its co-owner and managing officer, for marketing unapproved stem cell therapies, thereby creating infection risks.  Specifically, the agency alleges that the clinic’s therapies are manufactured through a process that FDA asserts deviate significantly from current Good Manufacturing Practices (cGMP), especially with respect to sterility, and that the clinic delayed an FDA inspection.  This complaint comes after the clinic failed to adequately address FDA’s concerns of an August 2017 warning letter.  The complaint alleges that FDA investigators reviewed numerous adverse events records during the 2017 site inspection, specifically referring to patients who received intravitreal (eye) injections of the unapproved product and suffered detached retinas and total blindness.  The agency alleges that the clinic’s “persistent refusal” to promise any corrections (on the basis that FDA lacks authority to regulate the SVF therapies) constitutes continued non-compliance which the court should restrain.

FDA also seeks an injunction against California Stem Cell Treatment Center, after finding the company lacked necessary FDA approvals and failed to correct cGMP deviations that created sterility risks observed during a 2017 inspection.  The complaint also names the Cell Surgical Network as well as two physicians who control the California Stem Cell Treatment Center and approximately 100 other for-profit affiliates through the network company.  FDA noted that the company was administering an unapproved stem cell product created using a combination of SVF and Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox.  FDA had seized five vials of the vaccine that the company intended to use in August 2017, as we summarized here following FDA’s announcement.  The product is marketed on the company’s website and brochures, and in YouTube promotional videos with claims referring to the product as “magical cells in your fat,” “liquid magic,” and for cancer therapies including “brain conditions…[by] injecting cells directly into the brain.” Furthermore, the agency alleges that patients were treated at other affiliates using the same protocols and equipment with SVF products, which may suggest further enforcement on the horizon.

FDA’s latest action further evidences the agency’s commitment to increasing oversight and enforcement in the regenerative medicine space, as first announced in November 2017 (previously discussed here).  Last week, Dr. Gottlieb announced that “additional enforcement actions that target some of the bad actors” should be expected.  After the current actions, Dr. Gottlieb reiterated the agency’s intent to take action in order to send a stronger deterrent message to those who are placing patients at risk and harming them. FDA has also recently highlighted a novel and efficient clinical development model as part of the framework for the development and approval of regenerative medicine products, including novel cellular therapies.

We will continue to monitor and report on FDA’s enforcement against US Stem Cell Clinic, California Stem Cell Treatment Center, and any other stem cell clinics as the agency continues to implement its revised risk-based framework.