World Patient Safety Day is recognized annually on September 17th. According to the World Health Organization, “World Patient Safety Day calls for global solidarity and concerted action by all countries and international partners to improve patient safety.” Patient safety is of the utmost importance, and we at Personalized Stem Cells take patient safety very seriously.
Safety of Stem Cell Therapies
The US Food and Drug Administration (FDA) has authority to regulate regenerative medicine products, including stem cell products. Currently, the only stem cell treatments that are FDA approved involve blood-forming stem cells derived from umbilical cord blood for use in patients with disorders that affect the production of blood. Unfortunately, there are numerous organizations that offer unapproved stem cell therapies, some of which may lead to adverse events.
Of course, all medical procedures may come with risks, but according to the FDA, unapproved treatments coming from dishonest and unscrupulous stem cell clinics may be particularly unsafe. Though stem cell therapy is still being performed by physicians without the approval of the FDA, it is consumer beware. Unfortunately, some of the treatments are lacking safety data and have caused injury, including blindness, to patients.
The Importance of FDA Regulation
In recent years, the FDA has increased their enforcement and oversight of stem cell products to protect unsuspecting patients from potentially harmful products and procedures. 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. Fortunately, there are many stem cell products being studied under Investigational New Drug Applications (INDs) that are approved by the FDA. This is where stem cell clinical trials come in.
Before approving an IND, the FDA performs in-depth and comprehensive reviews of the developmental stem cell product to ensure safety and effectiveness. As part of the process, the FDA reviews how each product is manufactured. This helps the FDA assess the safety, potency, and purity of the product. The FDA also requires any relevant data from animal studies to assess any potential risks associated with the use of the product. All of this is done prior to approving a stem cell clinical trial.
Personalized Stem Cells and Clinical Trial Safety
As most of you may know, PSC only offers FDA approved clinical trials and operates strictly within FDA guidelines. All of our stem cells are processed within FDA inspected facilities and are provided to physicians using FDA approved protocols. In addition, every precaution is taken to ensure patient cells are tested for quality and safety.
Our first FDA approved clinical trial for knee osteoarthritis was completed earlier this year. Safety was the primary objective of this study, and we are happy to report that there were no serious adverse events in any of the patients. You can read about more of the results here.