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Florida Company Barred from Using Experimental Stem Cell Drugs on Patients

Department of Justice

Office of Public Affairs


FOR IMMEDIATE RELEASE

Tuesday, June 25, 2019

A federal court ordered a Florida company claiming to offer stem cell treatments to stop selling or providing such products to patients, the Justice Department announced today.

In a complaint filed May 9, 2018, the United States alleged that defendants Kristin Comella, US Stem Cell Clinic Inc., and US Stem Cell LLC, of Sunrise, Florida, marketed “stromal vascular fraction” (SVF) products as stem-cell-based treatments for a host of serious conditions and diseases, including Parkinson’s disease, spinal cord injuries, stroke, and traumatic brain injury. According to the complaint, the defendants made such claims without approval by the Food and Drug Administration (FDA) and without proof of safety and efficacy. On June 3, District Judge Ursula Ungaro of the Southern District of Florida granted the government’s motion for summary judgment and denied a similar motion by the defendants, finding that the SVF products must comply with the Food, Drug, and Cosmetic Act (FDCA). On June 25, the Court entered a permanent injunction barring the defendants from selling or providing SVF products absent FDA approval.

“Clinics that purport to treat patients with unproven, experimental products must follow the law,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “The Department of Justice will continue to work with the FDA to ensure that manufacturers of experimental therapies conduct their research within the safe and legal bounds for drug innovation.”

“The Food, Drug, and Cosmetic Act is designed to protect the public health, and we are pleased that the Court found that the defendants in this instance are not exempted from FDA regulation,” said U.S. Attorney for the Southern District of Florida Ariana Fajardo Orshan. “This Office will continue our efforts to safeguard the public and individuals and corporations should be guided by this ruling and ensure that they comply with FDA standards.”

In ruling on summary judgment, the Court found that the defendants’ SVF product, which they manufactured from patients’ adipose (fat) tissue, was a drug subject to the FDCA. The Court further found that the defendants’ drug was misbranded because it did not bear adequate directions for use, and adulterated because the defendants did not comply with current good manufacturing practice (CGMP) in manufacturing the drug. The complaint alleged that the defendants and their affiliates used their unapproved and unlicensed products on thousands of patients and that, in some cases, adverse events that harmed patients followed treatment with the SVF products. According to the complaint, no credible scientific evidence supported the claims the defendants made that their products cure, mitigate, or prevent the conditions they purportedly treated.

“In the case against US Stem Cell Clinic, the clinic and its leadership put patients at serious risk through their disregard of the law and prior FDA warnings. This injunction is an important step in protecting patients from bad actors,” said Acting FDA Commissioner Ned Sharpless, M.D. “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 matter is being handled by Trial Attorney Roger J. Gural of the Civil Division’s Consumer Protection Branch, with the assistance of Assistant U.S. Attorney James A. Weinkle of the U.S. Attorney’s Office for the Southern District of Florida and Associate Chief Counsel for Enforcement Michael Helbing of the U.S. Department of Health and Human Services’ Office of General Counsel.

For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at https://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Southern District of Florida, visit its website at https://www.justice.gov/usao-sdfl.

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