FDA Obtains Permanent Injunction Against US Stem Cell

Janis C Kelly

June 04, 2019

A US District Court granted a permanent injunction requiring US Stem Cell Clinic to stop marketing adipose-derived stem cell treatments, which have been associated with severe complications in patients, including loss of sight.

US District Judge Ursula Ungaro from the Southern District of Florida has granted the government's motion for summary judgment against US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc, of Sunrise, Florida, and their Chief Science Officer Kristin Comella, PhD.

The summary judgment addressed one of two complaints against stem cell clinics filed by the Department of Justice on behalf of the US Food and Drug Administration (FDA) on May 9. The US Stem Cell Clinic case was decided fairly quickly because both sides had requested summary judgments.

The FDA argued that US Stem cell was marketing unapproved products that required FDA approval, that the company had multiple significant deviations from current good manufacturing practice and current good tissue practice requirements, and that the company had interfered with FDA inspection "by refusing to allow entry except by appointment only and denied the investigators access to your employees," which is a violation of the Federal Food, Drug, and Cosmetic Act.

Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, commented in a press statement, "In the case against US Stem Cell Clinic, the clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings. This decision today is a victory for the FDA's work to stop these bad actors and to protect patients. We are committed to continuing to pursue actions against those who put patients in harm's way by marketing unapproved stem cell products that skirt FDA's regulations and federal law."

The specifics of the FDA complaint were laid out in an August 24, 2017, warning letter and had been raised earlier with the company. The FDA notes in the warning letter that, in a May 16, 2017, written response to a previous letter from the agency, the company did not address any of the listed deficiencies but argued that the stem cell product was not a drug and that the company qualified for the "same surgical procedure" exception because adipose tissue from the patient was the source of stem cells injected or infused back into the same patient.

The FDA responded that components from adipose tissue were being processed into stromal vascular fraction (SVF) to be administered intravenously or intrathecally for a variety of disease or conditions, that this processing "alters the original relevant characteristics of the adipose tissue," and that the SVF product was not meant to perform the same functions as adipose tissue (eg, cushioning the body) but to be used in nonhomologous ways, making it a drug subject to the requirements for a biological product license requiring safety and efficacy testing.

The FDA initially raised concerns about US Stem Cell following an inspection of the facility that found that the company was administering its product intravenously or through other methods of administration to treat a variety of serious diseases or conditions, including Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, and pulmonary fibrosis. The FDA has not approved any biological products manufactured by US Stem Cell Clinic for any use.

The clinic was also cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.

Following these steps, a US court previously entered a consent decree of permanent injunction agreed to by the FDA and defendant Theodore Gradel, a former manager of US Stem Cell LLC, that requires Gradel to notify the FDA if he intends to re-enter the biologics industry and to comply with any corrective actions ordered by the FDA.

"Cell-based regenerative medicine holds significant medical opportunity, but those in this field who do not operate in compliance with the law can potentially cause serious harm to patients," said Acting FDA Commissioner Ned Sharpless, MD.

"We support sound, scientific research and regulation of cell-based regenerative medicine," Sharpless continued in the agency press release. "The FDA has advanced a comprehensive policy framework to promote the development and approval of regenerative medicine products. But at the same time, the FDA will continue to take action — such as issuing warning letters or initiating court cases — against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by manufacturing and promoting products in ways that make them drugs under the law, but which have not been proven to be safe or effective for any use. It is our responsibility to promote and protect public health, and we take this responsibility seriously."

Medscape Medical News reached out to US Stem Cell and its Chief Science Officer Comella for comment but did not hear back before press time.

In a separate action, the FDA is seeking a permanent injunction to stop California Stem Cell Treatment Center Inc, with locations in Rancho Mirage and Beverly Hills; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, MD, and Mark Berman, MD, from marketing cellular products without FDA approval.

This company and its associated network also market adipose-derived stem cells. The company and network include the Ageless Center of Regenerative & Wellness Medicine, Peachtree City, Georgia, and are currently being sued by Doris Tyler, a patient at that clinic who became completely blind following injections of "adipose-derived stem cells" into her eyes in an unapproved procedure, which the defendants claimed would treat her macular degeneration. Both Tyler's suit and the FDA litigation are ongoing.

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