FDA cracks down on clinics marketing unapproved stem cell therapies

The US Food and Drug Administration ...

Posted: May 10, 2018 5:12 PM
Updated: May 10, 2018 5:12 PM

The US Food and Drug Administration filed two federal complaints Wednesday seeking to permanently ban two clinics from marketing stem cell products without regulatory approval and accusing them of "significant deviations" from good manufacturing practice requirements.

Permanent injunctions are sought for US Stem Cell Clinic LLC of Sunrise, Florida, and California Stem Cell Treatment Center Inc., which includes the Cell Surgical Network Corp., in Rancho Mirage and Beverly Hills. The FDA also cited officers of both companies in its legal actions.

FDA seeks to permanently ban two stem cell clinics from marketing treatments

Manufacturing violations could impact the sterility of products, FDA says

Manufacturing violations could impact the sterility of products used at both companies, placing patients at risk, the FDA said.

"In the two cases filed today, the clinics and their leadership have continued to disregard the law and more importantly, patient safety," FDA Commissioner Dr. Scott Gottlieb said in a statement. "We cannot allow unproven products that exploit the hope of patients and their loved ones."

Stem cells are sometimes called the body's master cells, as they develop into blood, brain, bones and organs and have the potential to repair, restore, replace and regenerate cells. Scientists believe it is possible these cells can be used to treat many medical conditions and diseases. The FDA has not approved any stem cell-based products for use as treatments other than blood-forming stem cells derived from umbilical cord blood, according to the agency's website.

In August, the FDA posted a warning letter after an inspection of US Stem Cell Clinic. The agency said, that, though it had never reviewed or approved any of its biological products, the clinic was creating stem cells from body fat and administering them intravenously or directly into the spinal cords of patients to treat Parkinson's disease, amyotrophic lateral sclerosis, chronic obstructive pulmonary disease and other serious conditions.

FDA investigators also documented evidence that the clinic failed to establish and follow appropriate procedures to prevent microbiological contamination of products, which puts patients at risk for infections. US Stem Cell Clinic also refused to allow FDA investigators entry, except by appointment, and denied access to employees, the agency alleged. Refusing to permit entry or an FDA inspection is a violation of federal law.

US Stem Cell said in a statement Wednesday that it intended to "vigorously defend" itself with respect to the FDA's lawsuit. Chief Science Officer Kristin Comella said, "It is my life's work to pioneer regenerative medicine and educate the public about its healing potential. ... No government agency should deprive individuals of their right to harness the cells that exist in their body."

The company did not comment on FDA's assertion that it violated good manufacturing practice requirements.

Also in August, the FDA seized from California Stem Cell Treatment Centers five vials of vaccinia virus vaccine (live) belonging to Stemimmune Inc. of San Diego. Each of the vials originally contained 100 doses of the vaccine, which is usually reserved for people at high risk of smallpox (such as military personnel), yet one vial was partially used. ?

After being mixed with stem cells, the unapproved concoction was injected directly into the tumors of cancer patients at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the FDA said. Co-founder Dr. Elliot B. Lander said the centers were participating in studies that had been approved by international review boards.

At the time, the FDA said it had "serious concerns" about how StemImmune obtained the vaccine, which is not commercially available. Because its investigation is ongoing, the FDA is unable to comment on this aspect of the case, said FDA spokeswoman Lyndsay Meyer.

California Stem Cell Treatment Center Inc. and StemImmune did not immediately respond to a request for comment on the FDA's latest actions.

Gottlieb said, "Cell-based regenerative medicine holds significant medical opportunity, but we've also seen some bad actors ... peddle unapproved treatments that put patients' health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products."

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