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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 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2025-12-23 |
| Est. Completion | 2028-11-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07254806
The ClinicalTrials.gov registry entry for NCT07254806 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DiscGenics, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07254806 reports 12 study locations spanning 10 distinct geographic areas — top geographies include Idaho, North Carolina, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07254806?
The interventions under investigation include: IDCT (rebonuputemcel) (BIOLOGICAL), Sham (No Treatment) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07254806?
This trial is sponsored by DiscGenics, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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