Stem cells can differentiate into multiple tissue types such as bone, cartilage, muscle, and even cardiac and nerve tissues. They are sometimes called the “master cells” of the body. Literature demonstrates that stem cells have the ability to repair, regenerate, and replace cells that have been damaged or affected by injury or disease.
Stem cell therapies have the potential to treat diseases and conditions for which few treatment options currently exist. However, there are some dishonest and unethical providers that claim to offer stem cell products which are not FDA approved or part of an FDA approved clinical trial. These treatments, when unapproved and unproven, are possibly dangerous.
The Food and Drug Administration (FDA) has increased their enforcement of rules regulating stem cell therapy products in order to protect people from potentially dangerous treatments. They are also continuing to encourage research so the full potential of stem cell products can be safely developed.
FDA Approved Clinical Trials
The FDA performs in-depth and comprehensive reviews of developmental stem cell products to ensure their 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 use of the product.
The FDA does not directly perform clinical trials. The clinical trials are performed by the Investigators and are designed to determine the safety and effectiveness of developmental therapies. You can read more about clinical trials here.
For People Considering Participation in Clinical Trials
Before receiving any stem cell therapy, ask your provider for the FDA Investigational New Drug (IND) application number. This is proof that there has been review by the FDA regarding the experimental treatment. Potential clinical trial participants must receive specific and detailed information regarding the trial. It is advisable to ask questions if you do not understand the procedure in its entirety. After reviewing the information, the patient is required to give written informed consent. Learn more about informed consent here.
It is important to note that the FDA only oversees trials and treatments that take place in the United States.
PSC’s Current Clinical Trial
Personalized Stem Cells (PSC) processes stem cells in an FDA-inspected facility and provides these cells to physicians using FDA approved protocols. Every precaution is taken to ensure the patients’ cells are tested for quality and safety.
PSC is currently conducting an FDA approved clinical trial to study the effects of autologous, adipose-derived stem cell therapy for the treatment of single knee osteoarthritis. Though the trial is underway, PSC is not currently soliciting patients for inclusion in the trial. For information regarding future clinical trials, please contact us.