Phase III Study of Autologous Nucleus Pulposus Cell Injection for Treating Degenerative Disc Disease with Disc Herniation

What this Trial Is About

Degenerative disc disease DDD is a common condition in adults that causes low-back pain due to the loss of water retention and structural changes in the spinal discs. This trial evaluates the safety and effects of injecting autologous nucleus pulposus cells aNPC into degenerated discs in patients with disc herniation requiring discectomy. The study aims to improve pain, quality of life, and disc structure using this regenerative cell therapy. Participants will receive a single injection of their own cultured nucleus pulposus cells into the damaged disc, guided by X-ray for precise placement. The total injection volume will not exceed 3 mL, with about one million viable cells per milliliter. After treatment, subjects will be followed for 12 months to monitor safety and effectiveness. The trial includes imaging studies and patient questionnaires to assess outcomes. During the study, participants will undergo safety tests including blood markers of inflammation, liver and kidney function tests, and monitoring for adverse events. Pain levels will be tracked using the Visual Analogue Scale VAS along with assessments of daily activities and disability. Imaging with lumbar X-rays and MRI will be reviewed independently to evaluate disc regeneration and water retention. Follow-ups will occur regularly over the year-long observation period to gather comprehensive data on treatment impact and safety.

EvaluatIon of Autologous Nucleus Pulposus Cells (aNPC) in Degenerative Disc Disease