U.S. Food and Drug Administration main campus building. Photo: ALM U.S. Food and Drug Administration main campus building. Photo: ALM

A federal judge in the Southern District of Florida has ordered a South Florida stem cell clinic to discontinue one of its treatments and convene with prosecutors to agree on the parameters of a permanent injunction issued against it.

On Tuesday, U.S. District Judge Ursula Ungaro approved U.S. Stem Cell Inc.’s motion to arrange for a meeting with the United States Food and Drug Administration on the scope of the injunction imposed against the experimental health care company. Ungaro had ordered the injunction on the previous day when she granted the federal agency’s motion for summary judgment against the stem cell care provider and defendants Theodore Gradel and Dr. Kristin Comella.

Although Ungaro concurred with the defendants that “a mutually agreed upon injunction would be desirable,” she stressed that the conditions of the injunction against them still stand through the June 14 deadline for an agreement.

“The court will not permit defendants to use this time as a grace period to continue to violate the [Federal Food, Drug, and Cosmetic Act],” she said. “Accordingly, until an injunction is entered by this court, defendants are prohibited from selling and/or engaging in any [stromal vascular fraction] therapy or other activities to be regulated by the FDA.”

The stromal vascular fraction therapy is at the center of the dispute between U.S. Stem Cell and the FDA. The department filed a complaint against the company in May 2018 alleging the company was improperly using SVF therapy — wherein a liposuction is performed to produce adipose that can be processed to purportedly heal damaged tissue elsewhere in the body —without proper FDA approval or oversight.

“Defendants are well aware that the SVF product is subject to regulation as a drug and biological product … and that their conduct violates the law and could lead to regulatory action,” the suit said. The complaint also noted patients who’d undergone the procedure were left blind.

Read the court’s order issuing an injunction: 

Ungaro’s order granting the prosecutors’ motion for summary judgment held SVF therapy is subject to FDA regulation despite the defendants’ objections. She also agreed with the FDA that “there is a reasonable likelihood that Defendants will continue to violate the FDCA” as U.S. Stem Cell “continuously performed the SVF therapy in noncompliance” with warning letters from the federal agency.

In a press release issued by the department, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, called the ruling “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 [the] FDA’s regulations and federal law,” he said.

U.S. Stem Cell provided the Daily Business Review with a statement expressing disappointment with the court’s order.

“While we believe there is substantial evidence to prove the efficacy of this protocol, we must immediately comply with the court as we review the decision,” the statement said. “U.S. Stem Cell Inc. and U.S. Stem Cell Clinic will continue to operate business as usual, but no longer offers the adipose/SVF procedure. We’re hopeful the FDA will keep striving to work with the industry to establish clarity around life-saving innovations in regenerative medicine.”

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