FDA Cracks Down on Regenerative and Stem Cell Therapies


New therapies hold great promise-and great danger.

The FDA is looking a lot more closely at the fields of regenerative and stem cell therapies-therapies that are showing a lot of promise, but have still shown few proven benefits. The lack of proven results is not stopping many companies from misleading patients with claims of cures for many conditions.

Regenerative medicine, which includes stem cell therapies, uses human cells or tissues that have been engineered or are from a donor. Some types of stem cell transplants are approved for use in treating some forms of cancer and for growing skin grafts, but they have clinical trials that back up their efficacy.  

The field is still wide open, with many prospective therapies in the earliest stages of research. “These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies,” said FDA Commissioner Scott Gottlieb, MD, in a statement.

“To make sure the agency is separating the promise from the unscrupulous hype, we are stepping up our enforcement activity in this area,” Gottlieb said. The FDA will advance a comprehensive policy framework that will give clear description of the rules for the new field, he added.  

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The guidelines will be used to fight companies and individuals-the FDA calls them “unscrupulous actors”-that have seized on the promise of regenerative medicine to make “deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” Gottlieb said.

In one recent instance, authorities in California seized vials of a smallpox vaccine that was being used to create an unapproved stem cell product, which was then administered to patients with cancer. The treatment could have caused myocarditis and pericarditis. The product was being injected intravenously and directly into tumors by California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills.

The FDA has also sent a warning letter to a clinic in Sunrise, FL, that is marketing unapproved stem cell products.

Gottlieb said that these unscrupulous companies are putting the field of regenerative medicine and stem cell therapies at risk. “Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science,” he said. “[A] select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients.” 

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