LOS ANGELES (CN) – The Food and Drug Administration is seeking a permanent injunction to stop two stem cell clinics from treating patients with stem cell products for serious health conditions and diseases, claiming that the treatments were marketed without proof of safety from the FDA, according to complaints filed Wednesday in federal court.
California Stem Cell Treatment Center, which has clinics in Rancho Mirage and Beverly Hills, told patients its stem cell products could treat cancer, pulmonary disease, arthritis, stroke and other conditions without first seeking FDA approval that such treatments were safe and efficacious.
The company and its owners Elliot Lander and Mark Berman, along with Cell Surgical Network were named as defendants in a complaint filed in the Central District of California by the U.S. Department of Justice on behalf of the FDA.
Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center.
A separate complaint said Florida-based U.S. Stem Cell Clinic also marketed stem cell products to patients without FDA approval and manufactured its products in ways that affected product sterility, putting patients at risk.
Kristin Comella, the company’s chief scientific officer and Theodore Gradel, co-owner and managing officer, were named as defendants in the case filed Wednesday in the Southern District of Florida.
In a prepared statement on its website, U.S Stem Cell said it would “vigorously defend” the federal lawsuit.
Comella, said it was her “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,” Comella said.
California Stem Cell Treatment Center did not immediately respond to a request for comment by press time Wednesday.
“Marketing unproven and potentially unsafe treatments puts consumers at risk,” said Chad Readler of the Justice Department’s Civil Division.
Readler said manufacturers can innovate drug treatments but should use experimental stem cell therapies “within the safe and legal bounds.”
California Stem Cell Treatment Center manufactured an experimental stem cell product called “stromal vascular fraction” from patients’ fat tissue, then marketed it as a stem cell-based treatment for a host of serious conditions and diseases including cancer, multiple sclerosis, Parkinson’s disease and diabetes.
FDA Commissioner Scott Gottlieb said the agency has not approved any products manufactured by California Stem Cell Treatment Center “for any use.”
“Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk,” Gottlieb said in a written statement. “We cannot allow unproven products that exploit the hope of patients and their loved ones.”
Gottlieb said in some instances, patients have “suffered serious and permanent harm” after receiving treatment by stem cell products not approved by the FDA.
During inspections of California Stem Cell Treatment Center’s Beverly Hills and Rancho Mirage facilities in July 2017, FDA investigators documented evidence of significant violations of current manufacturing practice requirements, according to the FDA.
The clinics were cited for failing to establish and follow appropriate procedures designed to prevent microbiological contamination of products purporting to be sterile, which put patients at risk for infections, the statement said.
In Aug. 2017, the U.S. Marshals Service seized five vials of a vaccine California Stem Cell Treatment Center used to create an unapproved stem cell product which it then administered to cancer patients with “potentially compromised immune systems,” the FDA statement said.
The vaccine, which was inserted directly into patient’s tumors, “posed a potential for harm, including the possibility of inflammation and swelling of the heart and surrounding tissues.”
The FDA said it supports “sound, scientific research and regulation of cell-based regenerative medicine” and issued four guiding documents in Nov. 2017 to advance a framework for seeking approval of stem cell products.
“But at the same time, the FDA will continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health,” Gottlieb said.
The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center and Cell Surgical Network to cease the treatments and to allow the FDA to inspect the clinics.