“We have been very disappointed in the number of clinics that have come in,” the FDA’s Dr. The FDA hasn’t disclosed how many clinics sought approval since 2017, but public comments suggest it was troublingly low. But the FDA has concluded that processing stem cells and giving them to patients with serious diseases amounts to creating a new drug, which the agency regulates. Many stem cell doctors continue to argue that their in-office procedures are outside the FDA’s purview. He pointed to a multiyear effort by the FDA to help clinics through the review process. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at an industry conference in June. “It’s time to actually get the data we need,” to assess clinics’ stem cell procedures, Dr. Another case against a similar prominent company is pending in California. Regulators also prevailed in a Florida court case to shut down a major clinic offering unproven treatments. During the FDA’s three-plus years of “enforcement discretion,” the agency sent formal warning letters to more than a dozen businesses performing the riskiest procedures. The FDA has repeatedly warned Americans to steer clear of unapproved and unproven stem cell therapies, which have occasionally caused blindness, bacterial infections and tumors. He’s working on an update but says the number has consistently grown. But Turner counted more than 1,200 of them in 2019, up from the 570 clinics he and a co-author identified in 2016. There is no government tally of how many clinics operate in the United States. Others use bone marrow or blood taken from umbilical cords after birth. Some clinics use stem cells derived from fat, harvested via liposuction and then reinjected into patients, aiming to repair joints or fight disease. No clinic has yet won FDA approval for any stem cell offering and regulators now confront an enormous, uncooperative industry that contends it shouldn’t be subject to regulation.īusiness Column: Don’t be taken in by stem cell firms offering unsubstantiated therapies for COVID-19Ĭlinics with unproven stem cell treatments are already targeting COVID-19 fears. The continuing spread of for-profit clinics promoting stem cells and other so-called “regenerative” therapies - including concentrated blood products - illustrates how quickly experimental medicine can outpace government oversight. “The scale of the problem is vastly larger for FDA today than it was at the start.” “It backfired,” said Leigh Turner, a bioethicist at UC Irvine. government in 2017: They would have three years to show that their questionable treatments were safe and effective before regulators started cracking down.īut when the Food and Drug Administration’s grace period expired in late May - extended six months due to the pandemic - the consequences became clear: Hundreds more clinics were selling the unapproved treatments for arthritis, Alzheimer’s, COVID-19 and many other conditions. Hundreds of clinics pushing unproven stem cell procedures caught a big break from the U.S.
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