Backers of Maryland’s stem cell ecosystem hope a federal judge’s ruling last week in a Florida case that the Food and Drug Administration can regulate stem cell treatments is the first step toward protecting their legitimacy.
The case in Florida involved a clinic that made claims without evidence that its treatments would help treat a variety of diseases. Many Maryland companies that work with startups hope to draw a distinction between those clinics and their work, which is more evidence-based.
“It’s important to know, as far as I know, up until now, there is not a single FDA-approved product here on the market in the U.S.,” said Dan Gincel, executive director of the Maryland Stem Cell Research Fund. “We will have in the future stem cell products on the market, and right now we don’t. It is unsafe and in some cases irresponsible for those clinics to publicize stem cell treatments for patients.”
Stem cell treatments have been popularized by some athletes, like Kobe Bryant, Dirk Nowitzki and Tiger Woods, who received stem cell treatments in Europe to help recover from injuries and prolong their careers.
Those procedures have not been approved in the United States, but they captured the public imagination about what stem cells can do. The clinic in Florida at the center of the federal case advertised that its stem cell treatments could treat diseases, including Parkinson’s disease.
“First of all it’s good for patients, because these clinics don’t have a scientific basis for the work that they are doing and they are demonstrably harming patients,” said Debra Mathews, vice chair of the Maryland Stem Cell Research Commission and a bioethicist at Johns Hopkins School of Medicine. “It’s good not only for them and it’s good for legitimate companies not only because they can say they are doing it the right way, but because there is enforcement against the charlatans.”
Maryland stem cell proponents want there to be a dividing line between bad actors and what they do so there is no confusion in the public about what stem cells can provide.
The stem cell research fund provides funding for companies that are developing stem cells as part of a treatment. It has several layers for companies to get funding, including bioethical and Institutional Review Board approval.
“This is to ensure, again, the safety of what we do and the safety of the product that our companies are working (on),” Gincel said.
At the same time, the Florida ruling applies to just one clinic right now out of hundreds in operation across the country.
Mathews sees the ruling as the first step down a long road because it requires the FDA to exert jurisdiction.
“It will take a lot more to address the hundreds of similar clinics around the clinic doing this kind of work,” she said. “This is a hopeful sign, but it’s a small victory.”