Study of VIA Disc NP Injection for Treating Lumbar Discogenic Pain in Adults with Degenerative Disc Disease

What this Trial Is About

This research investigates the safety and effectiveness of VIA Disc NP, a non-surgical treatment designed to supplement nucleus pulposus tissue in people experiencing lumbar discogenic pain due to degenerative disc disease DDD. The study is a randomized, sham-controlled, double-blind trial conducted across multiple centers, including an initial open-label roll-in phase for one participant per site. It focuses on adults aged 22 to 85 years with moderate to severe disc degeneration confirmed by MRI and persistent low-back pain unresponsive to conservative care. Participants receive a single intradiscal injection of VIA Disc NP, which is made from processed cadaveric disc tissue, at up to two affected lumbar levels L1-S1. Participants who enroll after the roll-in phase are randomly assigned in a 21 ratio to receive either the VIA Disc NP injection or a sham procedure where a needle is inserted but no injection is given. Those initially assigned to the sham group who continue to have symptoms after 12 months may cross over to receive VIA Disc NP and undergo an additional 12 months of follow-up. During the study, participants will be monitored through assessments including pain severity using the Visual Analog Scale VAS and safety evaluations for any treatment-related adverse events over a 12-month period. The primary outcomes measure the proportion of participants achieving meaningful improvement in pain scores and the incidence of treatment-related side effects. The study duration includes screening, treatment, and follow-up visits, with careful tracking of participants symptoms and safety throughout the trial.

Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease