(CNN) — The US Food and Drug Administration won a major legal victory in its ongoing effort to crack down on clinics marketing bogus and potentially hazardous stem cell products.
On Monday, a federal judge in Miami granted the FDA an injunction to prevent the Florida-based US Stem Cell Clinic from offering treatments designed to create 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.
Over the last four years, FDA investigators documented evidence that the clinic failed to establish and follow appropriate procedures to prevent microbiological contamination of products which it said put 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 for an FDA inspection is a violation of federal law.
US Stem Cell Clinic maintained it was not required to comply with FDA regulations, claiming the procedure did not fall under the agency’s Food, Drug, and Cosmetic Act.
In the ruling, US District Judge Ursula Ungaro dismissed the clinic’s argument, writing that the FDA acted within its powers and there was “a reasonable likelihood” that the clinic would continue to violate the law.
“This case is an important victory in the FDA’s work to protect the public health,” the FDA said in a statement following the ruling. “We’ve been taking action, like this case, against clinics that abuse the trust of patients and endanger their health. We will continue to promote the sound and scientific development of regenerative medicine products, but we will not tolerate those in this field who try to skirt the law and put patients in harm’s way.”
Former FDA commissioner Scott Gottlieb called the decision “a critical precedent” and a step toward “efficient, effective, safe oversight of cell based regenerative medicine”
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 recent years, the agency has been waging an offensive against clinics offering unapproved stem cell therapies. Last week, the agency sent a warning letter to an Arizona-based clinic and its affiliates for suspicious marketing.
“We continue to see companies and individuals use questionable marketing campaigns to take advantage of vulnerable patients and their families with unproven claims about their unapproved stem cell products,” Acting FDA Commissioner Dr. Ned Sharpless said in a statement about the action. “The reality is that at this time, there isn’t enough evidence to support the use of stem cells for purposes other than reconstitution of blood formation and the immune system.”
A 2017 paper published in the New England Journal of Medicine recounted how three women with macular degeneration, ages 72 to 88, were left blind after a stem cell treatment at an unnamed clinic in Florida in 2015.
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