Stem cell therapy is an up-and-coming field which has the potential to turn up cures for previously-incurable diseases. Amidst the loopholes in FDA regulations, which had previously failed to keep up, unethical clinics have sprung up, falsely claiming to offer revolutionary ‘stem cell treatments’ which are, in fact, not proven to work and may even be fatal for patients.

But all that is changing, as the FDA announced that it would be cracking down on such bogus clinics while facilitating the release of legitimate treatments in the market by providing clear guidance for vetting such treatments.

"There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products," said FDA Commissioner Scott Gottlieb in a statement on 26 August 2017.

"I've directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health," wrote Gottlieb. "We have examples where some of these unproven treatments have clearly harmed patients."

FDA head Scott Gottlieb pledges to tighten regulations on stem cell practices, in view of recent report of unregulated use of a small pox vaccine in a stem cell concoction for cancer patients. Photo credit: FiercePharma
FDA head Scott Gottlieb pledges to tighten regulations on stem cell practices, in view of recent report of unregulated use of a small pox vaccine in a stem cell concoction for cancer patients. Photo credit: FiercePharma

“Decisive action” taken by the FDA

The agency has sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for "marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements."

The clinic, which claims to use stem cells derived from a person's own fat to treat a variety of conditions, is the same one which administered the ‘stem cell treatment’ for macular degeneration to three women and caused at least one of them to be permanently blinded.

The warning letter noted that US Stem Cell had denied FDA inspection, claiming that its work was not subject to agency regulation. It also accused the company of failing to establish proper quality control and sanitary standards.

The FDA has also reportedly taken "decisive action" to "prevent the use of a potentially dangerous and unproven treatment" offered by StemImmune Inc. of San Diego, California, which was administered to patients at California Stem Cell Treatment Centres in Rancho Mirage and Beverly Hills, California.

US Marshalls confiscated five vials of live vaccinia virus vaccine, reserved for people at high risk for smallpox, which were being mixed with stem cells and injected directly into the tumours of cancer patients.

Stem cell researchers laud the FDA’s new policy as being “spectacular”

Such enterprises “put the entire field at risk,” said Gottlieb. “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.”

The FDA’s actions have garnered plenty of praise. "This is spectacular," says George Daley, leading stem-cell researcher and dean of the Harvard Medical School. "This is the right thing to do."

"I see this is a major, positive step by the FDA," said Paul Knoepfler, a professor of cell biology at the University of California, Davis, who documented the rapid growth of stem-cell clinics. "I'm hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell "treatments" that may not be real treatments."

But some view the FDA’s announcements with more cynicism.

"I wish it hadn't taken this long," said Leigh Turner, associate professor at the Center for Bioethics at the University of Minnesota. "This is a space where the FDA could have taken action four or five years ago as far as making this a policy priority."

Turner pointed out that Gottlieb's statements allowed for "a bit of slippage as far as what exactly the FDA is going to do and which businesses they are going to target." He also questions how far unscrupulous clinics are allowed to carry out their activities before the FDA will step in.

"… do we actually require people being blinded before the FDA does something?" he asked, noting that "there's a considerable amount of uncertainty in terms of what we should expect in the months ahead. The statement itself doesn't provide clear answers to all those questions."

To the consumers, "If you see a business that's making all sorts of dramatic marketing claims across disease categories, claiming to use fat as a treatment for all sorts of indications, these are all signs to be wary of,” advised Turner. MIMS

Read more:
China imposes extreme punishments to counter fake clinical trial data submissions
4 latest stem cell research and applications
Synthetic retina created for the visually impaired