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

NCT07254806 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-04-21

No results posted yet for this study

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)

Conditions

  • Degenerative Disc Disease

Interventions

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.

Sponsors & Collaborators

  • DiscGenics, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa Flood · DiscGenics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-23
Primary Completion
2027-11-24
Completion
2028-11-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07254806 on ClinicalTrials.gov