Unlicensed stem cell treatments proliferates as market booms

Nearly 2,800 clinics operated by almost 1,500 companies are marketing unapproved stem cell treatments that lack clinical evidence of efficacy and safety, according to a study published in the journal Cell Stem Cell Thursday.

Business in unlicensed stem cell therapies is growing. As of March, there were more than four times as many companies and clinics offering these treatments as there were in 2016, said Leigh Turner, a professor at the University of California, Irvine, and the study’s author. The research determined there were 1,480 businesses owning 2,754 clinics selling these stem cell therapies.

Despite efforts by the Food and Drug Administration to enforce stem cell regulations and get providers into compliance, the non-FDA-approved stem cell therapy market has increased dramatically, Turner said.

“We’ve created an economic environment where there are a lot of reasons not to go the compliant route, because it’s really challenging to develop safe and efficacious products,” Turner said. “This is a marketplace where businesses can jump in right away, not do any clinical research or comply with federal regulations, but they can make money right away.

The FDA has approved 22 cellular and gene therapies, mostly for treating cancer, alongside other rare and life threatening disorders.

The agency also has attempted to rein in unlicensed stem cell treatments through enforcement actions such as warning letters and other communications to providers. The FDA and the Justice Department also have obtained permanent injunctions against some companies.

Growth in this market has only made the regulatory challenge harder for the FDA, states and medical boards, which means a tougher approach is needed, Turner said. “It’s encouraging to see the regulatory response, but I think that the marketplace itself is outstripping that response,” he said.

The companies offering unapproved therapies market them as treatments for a wide range of diseases and injuries without first undertaking proper clinical trials, the study found.

California has the largest concentration of clinics marketing unlicensed treatments, with 347 clinics, Florida is next with 333, followed by Texas with 310. More than one-third of the clinics performing these stem cell therapies are located in those three states.

Some clinics are units of publicly traded companies, and many others are operated by academic institutions and university-based health systems, Turner said.

While 22.9% of these businesses represent themselves as stem cell clinics or stem cell and regenerative medicine providers, others focus on areas like pain relief, orthopedic care, integrative medicine, chiropractic care, sports medicine, wellness and cosmetic surgery, the study found. And 85.3% tout their therapies for pain, orthopedic diseases or injuries.

Forms of autologous stem cell-based products are the most commonly advertised interventions, with 671 businesses selling bone-marrow-derived stem cell therapies and 437 marketing adipose-derived stem cell treatments. Forty percent of these providers market mesenchymal stem cell treatments, and many offer allogeneic birth-tissue-derived stem cell products from umbilical cord blood or tissue, amniotic stem cells or placental stem cells. A subset of stem cell clinics, 14.9%, do not specify the cell source or type of cells they use.

In addition to questions about the safety and efficacy of these therapies, their growing availability hampers the medical research that could provide clinical evidence because they reduce the potential pool of study subjects, Turner said.

“Rather than going to a facility that’s offering a well-designed clinical trial, people instead spend $5,000 or $10,000 to go to a clinic where they can get whatever is advertised right away,” Turner said. “And they don’t have to worry about being in a clinical trial, being randomized or being given a placebo.”

Although it could be beneficial, partaking in stem cell therapies that aren’t FDA-approved or backed by significant scientific evidence is risky, said Paul Keckley, a health policy consultant who is managing editor of the Keckley Report.

Many patients looking for alternative treatment are not able to get accurate, reliable information online about their condition, as commercial sources have their own biases and even medical societies can sometimes disagree among themselves, Keckley said.

“It’s almost an embarrassment in the U.S. that we’ve not invested as heavily in making the evidence known to individuals, more widely accessible,” Keckley said.