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

This is a Phase III, randomized, double-blinded, Sham-controlled, multi-center study in subjects with single-level, symptomatic lumbar (L3- S1) intervertebral disc degeneration. The study will have a 52-week primary period followed by 52 week Follow-up Period (total of 104 weeks). The study protocol will be approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), and the study will be conducted in accordance with Good Clinical Practice (GCP). All subjects will provide written informed consent prior to Screening. Approximately 162 subjects will be enrolled in the study. Up to 45 days prior to treatment, subjects will be screened for study inclusion, which includes obtaining baseline MRI and X-ray imaging. Imaging results for subjects initially eligible for study participation will be sent to a central imaging vendor for review and confirmation of eligibility, including the number of levels with degeneration. Subjects meeting all inclusion/exclusion criteria will be assigned to the corresponding treatment arm group and subsequently randomized to IDCT…

• Visual Analogue Scale (VAS) for low back pain
• Oswestry Disability Index (ODI)
• Adverse Events
• Adverse events of special interest

1. Study completion expected

   24 Nov 2028

2. Primary completion expected

   24 Nov 2027

3. Last registry update

   23 Sept 2026

4. Started

   23 Dec 2025

5. Registered

   28 Nov 2025