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# New FDA Crack Down on ‘Unscrupulous’ Cell Therapy Clinics
- URL: https://www.fdaweb.com/new-fda-crack-down-on-unscrupulous-cell-therapy-clinics/
- Published: 2017-08-28T12:00:00.000Z
- Updated: 2026-09-14T22:44:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139482

FDA has put in place new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine. While stem cell research and regenerative medicine hold much promise, some clinics and “unscrupulous actors” are “exploiting the uncertainty” by making “deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” FDA commissioner **Scott Gottlieb** says in a [statement ](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm?ref=fdaweb.com)announcing a crackdown on such practices.  

“These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses,” Gottlieb says. “This puts the entire field at risk. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science. In such an environment a select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients. These so-called treatments run afoul of the FDA’s legal and regulatory framework governing this new field.”

The agency is planning to release this fall a “comprehensive policy framework” to describe the “rules of the road for this new field,” Gottlieb says. There will be a clear delineation “with bright lines separating new treatments that are medical products subject to the FDA’s regulation from those therapies that are individualized by surgeons in such a way that they are not subject to FDA regulation,” he says. “For example, sometimes when cells or tissues are taken from and given back to the same individual or when the cells or tissues do not undergo significant manufacturing, are intended to perform the same basic functions, and are not combined with another drug or device, among other factors; their benefits and risks are well understood. In these circumstances, the products may not require premarket review under current law. However, when significant manufacturing is performed on the cells or tissues, or when the cells or tissues are not intended to perform the same basic functions, far greater uncertainty exists as to the benefits and risks involved. In these cases, it’s necessary to understand the benefits and risks in clinical trials prior to widespread use of the products. Therefore, premarket review is required.”

As part of this new policy articulation, FDA will step up its enforcement activity in this area. “In the last few days alone, the FDA has taken steps in [Florida](https://mandrillapp.com/track/click/30964126/www.fda.gov?p=eyJzIjoiX1BkeFdnTjBlR2dad1JtTm8xdnRibFkybVFzIiwidiI6MSwicCI6IntcInVcIjozMDk2NDEyNixcInZcIjoxLFwidXJsXCI6XCJodHRwczpcXFwvXFxcL3d3dy5mZGEuZ292XFxcL05ld3NFdmVudHNcXFwvTmV3c3Jvb21cXFwvUHJlc3NBbm5vdW5jZW1lbnRzXFxcL3VjbTU3MzQzMS5odG1cIixcImlkXCI6XCJlOTI0ZTFlNDcxYTE0YzU3YTg5OTc1YzEzNWJiNThkOVwiLFwidXJsX2lkc1wiOltcImY1NzU1MTQxYjAyYTk3MTg1ZDY1ODhlNGU1NmNiYjViNmM3YmM0ZDlcIl19In0&ref=fdaweb.com) and [California](https://mandrillapp.com/track/click/30964126/www.fda.gov?p=eyJzIjoiY1R4Qzk1eVFxUzNnVnNibUc2bkFfWkFydVRBIiwidiI6MSwicCI6IntcInVcIjozMDk2NDEyNixcInZcIjoxLFwidXJsXCI6XCJodHRwczpcXFwvXFxcL3d3dy5mZGEuZ292XFxcL05ld3NFdmVudHNcXFwvTmV3c3Jvb21cXFwvUHJlc3NBbm5vdW5jZW1lbnRzXFxcL3VjbTU3MzQyNy5odG1cIixcImlkXCI6XCJlOTI0ZTFlNDcxYTE0YzU3YTg5OTc1YzEzNWJiNThkOVwiLFwidXJsX2lkc1wiOltcIjI3NTQ0ZmUyOTJlMjBmZTg2MWI5NTgwZDhkYjNjNTQ2ZTM4MTQ0MWJcIl19In0&ref=fdaweb.com) to address a number of especially troubling products being marketed,” Gottlieb notes. “But unfortunately, these are examples of a larger pool of actors who claim that their unproven and unsafe products will address a serious disease, but instead put patients at significant risk. We will seek to take additional actions in the coming months as we address this field, and target those who are clearly stepping over the line, at the same time that they create a potential danger to patients. We have examples where some of these unproven treatments have clearly harmed patients.”

To illustrate its concern, FDA has released a new [Warning Letter](https://mandrillapp.com/track/click/30964126/www.fda.gov?p=eyJzIjoiMm9JNFU1VjNwdm5haWx0LTYwV1BJcGk0Qk9vIiwidiI6MSwicCI6IntcInVcIjozMDk2NDEyNixcInZcIjoxLFwidXJsXCI6XCJodHRwczpcXFwvXFxcL3d3dy5mZGEuZ292XFxcL0lDRUNJXFxcL0VuZm9yY2VtZW50QWN0aW9uc1xcXC9XYXJuaW5nTGV0dGVyc1xcXC8yMDE3XFxcL3VjbTU3MzE4Ny5odG1cIixcImlkXCI6XCJhNTQwNTQyZjlhODE0NDg2OGE2OWIyYmQ5ZjRkZTQyM1wiLFwidXJsX2lkc1wiOltcIjUxNzk1OTIxNzM3MWMyNDU3NmUzNWUxMThjMmNkYTYzOTYzODYwZDFcIl19In0&ref=fdaweb.com) to U.S. Stem Cell Clinic (Sunrise, FL) for marketing stem cell products without FDA approval and for significant deviations from GMP requirements, including some that could impact the sterility of their products, putting patients at risk. A recent inspection at the clinic found that it was processing adipose tissue (body fat) into stromal vascular fraction (stem cells derived from body fat) and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis, chronic obstructive pulmonary disease, heart disease and pulmonary fibrosis. The agency says it has not approved any biological products manufactured by the clinic for any use.

During the inspection, FDA investigators cited the clinic for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile. The clinic also tried to impede the agency’s investigation by refusing to allow entry except by appointment and by denying FDA investigators access to employees, the agency says.