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

Conditions

• Degenerative Disc Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date

Dec 23, 2025

Status verified

Apr 2026

Primary completion

Nov 24, 2027

Completion

Nov 24, 2028

Study Design

Enrollment

162 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: IDCT (n=108); Intradiscal injection of IDCT in a single target disc
  1 mL intradiscal injection of 9,000,000 cells/mL
• Sham Comparator: Sham (n=54);
  Needle insertion up to the annulus of a single target disc.

Primary Outcome Measure

Visual Analogue Scale (VAS) for low back pain [ Time Frame: Week 52 ]

Locations (14)

Find similar trials in Birmingham, AL

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