Phase II Study of Autologous Bone Marrow Mesenchymal Stem Cell Injection for Chronic Low Back Pain from Multilevel Lumbar Disc Degeneration

What this Trial Is About

Researchers are evaluating the effectiveness and safety of injecting autologous adult bone marrow mesenchymal stem cells BM-MSC into the discs of patients with chronic low back pain caused by lumbar multilevel intervertebral disc degeneration IDD that has not improved with standard treatments. This phase II B, randomized, controlled, double-blind trial aims to assess pain relief, functionality, and quality of life over a 24-month period. The study is motivated by the need for restorative treatments beyond current pain-relieving therapies, as IDD is a major cause of low back pain affecting a large portion of the global population. Participants will undergo either the experimental treatment involving bone marrow harvesting followed by a single injection of 15 million BM-MSC cells per affected disc up to three discs or a sham procedure simulating these steps without actual cell injection. The study includes detailed imaging control to guide the injections. The trial will compare the effects of the active stem cell therapy to the sham treatment, with evaluations at multiple time points including MRI scans at 6 months, 1 year, and 2 years to assess disc regeneration. During the study, participants will have regular assessments including pain measurement using VAS, functional disability evaluations, quality of life questionnaires, drug use monitoring, spine examinations, blood tests, and safety monitoring at baseline and at intervals up to 24 months. Researchers will also assess structural changes in the discs, employment status, and costs related to treatment. The total participation time is 24 months, allowing long-term observation of efficacy and safety outcomes.

Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD