FDA, New York Attorney General Go After Stem Cell Clinics

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.

See “Texas Stem Cell Law Opens Door for Controversial Treatments” 

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.”