FDA seeks injunctions against clinics over unapproved stem cell products: 8 things to know

The FDA is suing two stem cell clinics to stop them from marketing treatments the agency hasn't approved.

In addition, the FDA said it is seeking permanent injunctions against the clinics "for significant deviations from current good manufacturing practice requirements."

Here are eight things to know about the injunctions.

1. The FDA filed two complaints in federal court May 9.

2. One complaint seeks an injunction against US Stem Cell Clinic of Sunrise, Fla., its chief scientific officer Kristin Comella and its co-owner and managing officer Theodore Gradel. The FDA alleges these parties were involved in marketing stem cell products without the agency's approval and violated good manufacturing practice requirements. Some of the alleged violations, the agency said, could affect the sterility of products and in turn patient care.

3. The FDA sent a warning letter to the clinic in August 2017 regarding alleged violations identified at the facility during an agency inspection. The FDA asked the company to respond to the letter with a plan of corrective action. In the complaint, the agency contends the clinic did not address the violations and remained noncompliant.

4. Now, the FDA said it wants US Stem Cell and its representatives to stop marketing their stem cell products, receive approvals from the agency and comply with good manufacturing practice requirements.

5. The FDA's second complaint is against California Stem Cell Treatment Center, which has locations in Rancho Mirage and Beverly Hills; Cell Surgical Network Corporation of Rancho Mirage; and individual physicians Elliot B. Lander, MD, and Mark Berman, MD. The agency said it also seeks to stop these parties from marketing unapproved stem cell products.

6. As with the first complaint, the FDA said it wants these parties to stop marketing their stem cell products, receive approvals from the agency and come into compliance with good manufacturing practice requirements.

7. In a statement to The New York Times, Ms. Comella said of the injunction filings: "It is my life's work to pioneer regenerative medicine and educate the public about its healing potential. I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body."

8. Dr. Berman told The Times his clinic had helped many patients and that he unsuccessfully tried to reach a compromise with the FDA. Additionally, according to the publication, he said he believed stem cells should not be regulated as a drug.

Read more about the FDA's complaints here.


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