Unapproved Clinical Uses

There is a startling rise of clinics across the U.S. offering unproven and unapproved regenerative medicine therapies for various conditions like aging, arthritis, COVID 19 complications and even autism. These clinics make claims that lack solid scientific evidence. The safety and effectiveness of many regenerative medicine products outside a few approved uses are still not proven.

These clinics use products from people’s own bone marrow or fat, as well as tissues like placenta or cord blood from donors. Although some may believe these products are safe, they can actually be dangerous, especially if they aren’t made following proper guidelines. In fact, there have been serious cases where people got infections or other complications, such as blindness, after receiving unapproved stem cell treatments. Because of the growing number of harmful events linked to these therapies, the FDA has been taking steps to stop clinics from using them.

The vast majority of these unapproved therapies are being used without FDA approval, which is concerning because they haven’t been fully tested for safety or effectiveness. Some companies wrongly claim that their products don’t need FDA approval, but they do. Without proper oversight, it’s hard to know how many people have been harmed by these treatments.

The FDA has acted by warning companies and even seizing dangerous products, but they need help from doctors and patients to find and stop these unsafe practices. Patients should ask their doctors if a treatment is FDA-approved or if it’s part of an official clinical trial before considering it. They should also be informed that they shouldn’t have to pay for experimental treatments unless the FDA allows cost recovery for research purposes.