As you may know, Personalized Stem Cells (PSC) has begun providing autologous adipose-derived stem cell therapy services to a select few physicians in the United States for the treatment of osteoarthritis in the knee through a clinical trial. This initial clinical trial is the first FDA-approved clinical trial offered by PSC. But why is FDA approval so important?
Simply put: the FDA has the responsibility to the public to determine if the benefits of a new “drug” outweigh the risks. As such, the FDA has the authority to regulate stem cell therapy (products) in the United States through the Investigational New Drug (IND) process. This means that in order to be used legally, stem cell products must comply with processing and quality testing procedures defined by the FDA. The FDA approval process also includes analysis of supporting data/literature to determine potential risks and/or benefits associated with treatment.
Stem cell therapy is still being performed by physicians without the approval of the FDA, however it is consumer beware. Not only are physicians providing unauthorized stem cell treatments, some of the treatments are completely lacking safety data and have caused injury, including blindness, to patients.
Fortunately, the FDA has recently increased their enforcement and oversight of stem cell products to protect unsuspecting patients from potentially harmful products and procedures. The FDA has filed permanent injunctions for stem cell clinics that are not compliant. The FDA is also increasing enforcement of clinics offering unapproved products claiming to be stem cells. It’s not an easy job, however. The FDA walks a fine line between regulating stem cell products and continuing to encourage innovation in the field of regenerative medicine.
For these reasons, it is a good idea to ask if the FDA has reviewed the planned treatment before considering any stem cell procedure. In July of 2019, PSC announced the FDA approval of their IND to treat osteoarthritis with autologous adipose-derived stem cell therapy through clinical trials.
Once approval was received, the first clinical trial for the treatment of osteoarthritis in the knee launched soon after. Please contact us if you are interested in getting more information about this clinical trial or future clinical trials.