Last week marked a flurry of activity to rein in activities by stem cell clinics that give customers unproven interventions. On Wednesday (April 3), the Food and Drug Administration sent letters to 20 companies providing stem cell treatments, reports The New York Times, reminding them that they may require FDA approval and should take action to comply. The agency also issued a warning to a stem cell company for violating good manufacturing practices. Then a day later, New York Attorney General Letitia James filed a lawsuit against a stem clinic based in Manhattan.
“Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful, and immoral,” James says in a press release. “We will continue to investigate these types of clinics that shamelessly add to the suffering of these consumers by charging them thousands of dollars for treatments that they know are unproven.”
The letters and lawsuit are the latest moves by various government agencies to crack down on those who sell unproven stem cell treatments. Last year, the Food and Drug Administration (FDA) sued U.S. Stem Cell, a clinic that provides treatments using a patient’s own stem cells, in federal court in Florida for providing stem cell treatments without FDA approval, reports The Washington Post. The agency also filed suit in 2018 against California Stem Cell Treatment Center for marketing stem cell products without FDA approval.
Stem cell treatments may fall under FDA regulation and be treated like a drug if the cells are more than “minimally manipulated,” according to thePost. The current FDA actions are targeting stem cell treatments that extract so-called mesenchymal stem cells from fat, reports the Post.
There have been several cases of patients suffering from permanent eye damage from stem cell injections in their eyes that they received from U.S. Stem Cell. Another patient who received a treatment for arthritis pain from a clinic associated with U.S. Stem Cell experienced a serious reaction in the spring of 2018 and was in a coma for more than a month, reportsthe Post.
Kristin Comella, the chief scientific officer of U.S. Stem Cell, says the company no longer provides eye treatments but continues to treat five to 20 patients per week, reports the Times. U.S. Stem Cell received $6.7 million in revenue in 2018, operates three clinics, and claims to have provided relief to 10,000 patients, according to the Post.
Comella issued a statement to the Times saying, “It is my life’s work to pioneer regenerative medicine and educate the public about its healing potential. I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body.”