Plano-based Texas Back Institute researchers are assessing the effectiveness of stem cells for revitalizing spinal tissue in a clinical trial.
Scott Blumenthal, MD, spine surgeon at Texas Back Institute and Center for Disc Replacement, shared insight on the trial and the stem cell field in an article posted on Texas Back Institute's website.
Here are five things to know.
1. Dr. Blumenthal, lead researcher on the trial, commented, "We are excited to be a part of the process of evaluating the efficacy of stem cells for tissue rejuvenation on behalf of the FDA. It's a work-in-progress. All of those clinics that are offering some form of 'stem cell therapy' are using questionable and potentially dangerous medical practices."
2. The team will specifically hone in on the potential for stem cells to regrow spine or disc tissue by injecting stem cells from an outside source into a patient's disc.
3. Dr. Blumenthal said the trial is FDA-sanctioned, but not yet approved.
4. The FDA has been cracking down on stem cell clinics offering unproven and potentially harmful treatments. On Nov. 16, the agency released its regenerative medicine policy guidelines outlining a clearer picture of regulated biologic products. Two of the documents recommend a science-based process to guarantee the safety and efficacy of the therapies while not hindering development. Dr. Blumenthal said more than 500 stem cell clinics exist in the U.S., and patients should be cautious.
5. He concluded, "If we can intervene biologically with an injection of cells to help reduce or eliminate patient pain, we could avoid tens of thousands of surgeries."