Phase 3 Study to Test Safety and Effectiveness of IDCT Cell Therapy for Adults With Mild to Moderate Single-Level Lumbar Disc Degeneration

What this Trial Is About

This trial investigates the safety and effectiveness of Intradiscal Cell Therapy IDCT compared to a Sham procedure for adults aged 18 to 75 with mild to moderate symptomatic degenerative disc disease at a single lumbar level L3-S1. The study is a Phase III, randomized, double-blinded, sham-controlled, multicenter trial involving 162 participants. The target disc is identified by imaging and must meet specific grading criteria, with participants experiencing chronic low back pain unresponsive to conservative treatments. Participants will be randomly assigned in a 21 ratio to receive either a single intradiscal injection of 9 million cells in 1 mL IDCT or a Sham needle insertion up to the annulus of the target disc. The target disc is one of L3L4, L4L5, or L5S1. Randomization occurs 7 to 14 days before treatment. The study includes a 52-week primary evaluation period followed by an additional 52-week follow-up, totaling 104 weeks for monitoring. Throughout the study, participants will undergo baseline and follow-up assessments including MRI and X-ray imaging, Visual Analogue Scale VAS for low back pain, Oswestry Disability Index ODI, and other health and disability questionnaires. Adverse events and treatment safety will be tracked from Day 1 through Week 104. Researchers will also measure disc volume, pain medication use, and treatment failure rates while participants adhere to study protocols and visit schedules over two years.

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease