POST Online Media Lite Edition



 

NEWLY REPORTED COVID-19 CASES IN LAST 24 HOURS (7.30.2021, 6:30pm CEST, WHO):   U.S. 90,660    India 44,230    Brazil 48,013    Russia 23,564    France 25,080    The United Kingdom 30,633    Turkey 22,161    Argentina 15,883    Columbia 9,364    Spain 13,696    Italy 6,167    Iran 34,433    Germany 2,454    Indonesia 41,168    Mexico 19,028    South Africa 13,626    Peru 1,502    The Netherlands 4,506    Chile 1,371    Iraq 13,259    Philippines 5,734    Bangladesh 13,862    Malaysia 17,170    Pakistan 4,497    Portugal 3,009    Japan 10,425    Israel 1,013    Nepal 2,467    United Arab Emirates 1,550    Tunisia 3,676    Thailand 17,345    Saudi Arabia 1,289    Greece 2,694    Belarus 1,033    Georgia 2,712    Costa Rica 1,467    Cuba 8,607    Venezuela 1,009    Ireland 1,361    Myanmar 5,127    Honduras 1,282    Libya 2,730    Kenya 1,068    South Korea 1,710    Algeria 1,537    Mongolia 2,525    Vietnam 9,765    Mozambique 1,774    Botswana 4,566    Zimbabwe 2,089    Fiji 1,301    China 84    Singapore 133    New Zealand 3    Australia 261   

FDA seeks permanent injunctions against two stem cell clinics

Staff Writer |
The U.S. Food and Drug Administration (FDA), in two complaints filed today in federal court, is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.

Article continues below




l-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.

"In some instances, patients have suffered serious and permanent harm after receiving these unapproved products. In the two cases filed today, the clinics and their leadership have continued to disregard the law and more importantly, patient safety.

"We cannot allow unproven products that exploit the hope of patients and their loved ones," said FDA Commissioner Scott Gottlieb, M.D.

"We support sound, scientific research and regulation of cell-based regenerative medicine, and the FDA has advanced a comprehensive policy framework to promote the approval of regenerative medicine 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 with inadequate manufacturing conditions or by purporting to have treatments that are being manufactured and used in ways that make them drugs under the existing law but have not been proven safe or effective for any use."

A permanent injunction is being sought against U.S. Stem Cell Clinic of Sunrise, Florida, its chief scientific officer Kristin Comella and its co-owner and managing officer Theodore Gradel for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.

The FDA is taking this action because US Stem Cell Clinic did not address the violations outlined in a warning letter to the clinic and failed to come into compliance with the law.

The FDA is seeking an order of permanent injunction requiring U.S. Stem Cell and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval.

Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center.

The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

The FDA issued a warning letter to U.S. Stem Cell Clinic in August 2017 for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products.

The warning letter also cited an FDA inspection of the clinic which found that it was processing adipose tissue (body fat) into stromal vascular fraction (a cellular product derived from body fat) and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis.

The FDA has not approved any biological products manufactured by U.S. Stem Cell Clinic for any use.

During the inspection of US Stem Cell Clinic in April and May 2017, FDA investigators also documented evidence of significant deviations from current good manufacturing practices in the manufacture of at least 256 lots of stem cell products by the clinic.

For example, the clinic was cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.

The complaint for permanent injunction against US Stem Cell Clinic was filed by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the Southern District of Florida.

In August 2017, the FDA took action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills.

On behalf of the FDA, the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the U.S. military.

The seizure came after FDA inspections at StemImmune and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction – a cellular product derived from body fat).

The product was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including the possibility of inflammation and swelling of the heart and surrounding tissues.

The unproven and potentially dangerous treatment was being injected intravenously and directly into patients' tumors.

California Stem Cell Treatment Center products are also being used for the experimental treatment of patients who suffer from a variety of serious diseases or conditions, including cancer, arthritis, stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), macular degeneration, Parkinson's disease, chronic obstructive pulmonary disease (COPD) and diabetes.

The FDA has not approved any biological products manufactured by California Stem Cell Treatment Center for any use.

During inspections of California Stem Cell Treatment Center's Beverly Hills and Rancho Mirage facilities in July 2017, FDA investigators documented, among other violations, evidence of significant deviations from current good manufacturing practice requirements.

For example, the clinics were cited for failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.

The complaint for permanent injunction was filed by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the Central District of California.