WVU Hospitals East Launches First Phase 3 Trial Targeting Chronic Low Back Pain

MARTINSBURG, W.Va. — The WVU Rockefeller Neuroscience Institute (RNI) in the Eastern Panhandle has launched its first clinical trial, marking a significant milestone and expanding advanced research opportunities for patients with chronic lower back pain.The Phase 3 study, MSB-DR004, titled “A Prospective, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Combined With Hyaluronic Acid in Subjects With Moderate to Severe Chronic Low Back Pain,” is an industry-sponsored trial evaluating innovative therapies for chronic low back pain.

Shoji Ishigami, MD PhD, medical director of Interventional Spine and Pain at the RNI in the Eastern Panhandle, serves as the study’s principal investigator. Dan Nguyen, MD is the sub-investigator.

“We want to be at the forefront of physical medicine and rehabilitation. Not only helping patients recover and maintain function after surgery, illness or aging, but also working toward reversing disease processes through regenerative therapies such as mesenchymal precursor cell therapy,” Dr. Ishigami said.

This milestone is not only the first clinical trial at WVU Hospitals East but also the first clinical trial using mesenchymal precursor therapy for back pain within the WVU academic health system.

“Flexion-biased axial low back pain is one of the most difficult conditions to treat,” Ishigami said. “By participating in the frontier of regenerative medicine, we hope to offer West Virginians a treatment option that may reduce the need for chronic opioid therapy, decrease the risk of dependency and help people return to work faster. Launching this clinical trial is a major first step in bringing more advanced regenerative technologies to our state.”

If you suffer from lower back pain and are interested in participating in this study, contact Demi Reddinger, clinical trial supervisor at [email protected].