Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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)

Primary Outcome

VAS is a sliding visual scale of 0 being "no pain" and 100 being "worst pain Imaginable' to assess changesfrom baseline in low back pain compared to Sham

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
DiscGenics

2 total trials

What NCT07254806 shows while recruiting

NCT07254806 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 165-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target.

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 lists 12 locations in 10 states (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.

Learn More About Clinical Trials

Similar trials for Degenerative Disc Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07254806's enrollment target sits among peer trials

162 14th of 42 higher than 29 of 42 other Degenerative Disc Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Degenerative Disc Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02347111 · 162 participants · Phase 4

    Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

  • NCT02610426 · 162 participants

    Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Congestive Heart Failure Receiving Therapy for Breast Cancer

  • NCT05040711 · 162 participants · NA

    mHealth Mindfulness With Patients With Serious Illness and Their Caregivers

  • NCT05514717 · 162 participants · Phase 1

    A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT07254806

Source: ClinicalTrials.gov NCT07254806, the US trial registry maintained by the National Library of Medicine. NCT07254806 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.