NCT07254806

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

A Prospective, Randomized, Double-Blinded, Sham-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of IDCT in Subjects With Single-Level, Symptomatic Mild to Moderate Lumbar Intervertebral Disc Degeneration

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: DiscGenics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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 or Sham. Randomization will occur approximately 7 to 14 days prior to the scheduled treatment administration date. Overall, 162 subjects will be enrolled and randomized to IDCT or Sham in a 2:1 ratio. * IDCT (n=108) * Sham (n=54)

Detailed description

Adult subjects with a diagnosis of single-level, mild to moderate, symptomatic lumbar (L3-S1) intervertebral disc degeneration that give consent and meet all the inclusion criteria and none of the exclusion criteria will be enrolled in this study. The disease, single-level disc will be known as the 'target disc' and will be either L3/L4, L4/L5, or L5/S1.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
BIOLOGICAL	IDCT (rebonuputemcel)	Single intradiscal injection of 1 mL of 9,000,000 cells/mL IDCT in a single target disc.
OTHER	Sham (No Treatment)	Single Sham needle insertion up to the annulus of a single target disc.

Timeline

• Start date: 2025-12-23
• Primary completion: 2027-11-24
• Completion: 2028-11-24
• First posted: 2025-11-28
• Last updated: 2026-04-07

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study