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NCT07254806 · ClinicalTrials.gov registry record · Phase 3

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 Phase 3 study of Degenerative Disc Disease, sponsored by DiscGenics.

Recruiting
Registry status
Phase 3
Development phase
162
Enrollment target
12
Study locations

NCT07254806 is a Phase 3 study of Degenerative Disc Disease that is actively recruiting participants, run by DiscGenics. The registered enrollment target is 162 participants, roughly in line with the 165-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target. The trial reports 12 study locations across 10 states.

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The verdict

NCT07254806, a Phase 3 study of Degenerative Disc Disease, is actively recruiting participants, sponsored by DiscGenics.

RECRUITING
Registry status
Phase 3
Development phase
162 participants
Enrollment target
12
Study locations

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 Studied

Degenerative Disc Disease

Interventions

  • BIOLOGICAL IDCT (rebonuputemcel)
  • OTHER Sham (No Treatment)

Study Locations (12)

Idaho

  • Injury Care Family Care Research - Boise
  • Axis Spine Center - Post Falls

North Carolina

  • Wake Research - Wilmington
  • Carolinas Pain Institute/ Center For Clinical Research - Winston-Salem

Alabama

  • Alabama Clinical Therapeutics - Birmingham

California

  • Source Healthcare - Santa Monica

Indiana

  • Indiana Spine Group - Carmel

Missouri

  • The Orthopedic Center of St. Louis - St Louis

Oregon

  • Pacific Sports and Spine - Eugene

Tennessee

  • Semmes Murphey Neurological Clinic - Memphis

Trial Details

FieldValue
Enrollment Target 162 participants
Start Date 2025-12-23
Est. Completion 2028-11-24
Phase Phase 3

Sponsor

DiscGenics

2 total trials

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What the Registry Record Tells You About NCT07254806

The ClinicalTrials.gov registry entry for NCT07254806 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 165-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target. The listed sponsor is DiscGenics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which IDCT (rebonuputemcel) is the first listed.

NCT07254806 reports 12 study locations spanning 10 distinct geographic areas - top geographies include Idaho, North Carolina, Alabama.

Frequently Asked Questions

What is clinical trial NCT07254806 about?

NCT07254806 is a clinical study titled "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 protoco...

What is the current status of trial NCT07254806?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 162 participants. The study started on 2025-12-23. Estimated completion is 2028-11-24.

What conditions does trial NCT07254806 study?

This clinical trial studies the following conditions: Degenerative Disc Disease.

What interventions are being tested in trial NCT07254806?

The interventions under investigation include: IDCT (rebonuputemcel) (BIOLOGICAL), Sham (No Treatment) (OTHER).

Who is sponsoring clinical trial NCT07254806?

This trial is sponsored by DiscGenics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07254806 being conducted?

This trial has 12 study locations across Alabama, California, Idaho, Indiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.