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

ClinicalTrials.gov ID: NCT07254806

Public ClinicalTrials.gov record NCT07254806. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 4, 2026, 11:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Randomized, Double-Blinded, Sham-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of IDCT in Subjects With Single-Level, Symptomatic Mild to Moderate Lumbar Intervertebral Disc Degeneration

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID: NCT07254806
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: DiscGenics, Inc.; Industry
Enrollment: 162 participants

Conditions and interventions

Conditions

Degenerative Disc Disease

Interventions

IDCT (rebonuputemcel) Biological
Sham (No Treatment) Other

Biological · Other

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 22, 2025
Primary completion: Nov 23, 2027
Completion: Nov 23, 2028
Last update posted: Sep 3, 2026

2025 – 2028

United States locations

U.S. sites: 28
U.S. states: 20
U.S. cities: 28

Facility	City	State	ZIP	Site status
Alabama Clinical Therapeutics	Birmingham	Alabama	35235	Recruiting
Mayo Clinic (AZ)	Phoenix	Arizona	85054	Recruiting
Solaris Research Institute	San Diego	California	92111	Recruiting
Source Healthcare	Santa Monica	California	90403	Recruiting
Pain Management and Injury Relief	Thousand Oaks	California	91320	Recruiting
International Spine, Pain and Performance Center	Washington D.C.	District of Columbia	20006	Recruiting
Mayo Clinic (FL)	Jacksonville	Florida	32224	Recruiting
University of Miami Health System	Miami	Florida	33136	Recruiting
Conquest Research	Orlando	Florida	32832	Recruiting
Vantage Clinical Trials	St. Petersburg	Florida	33709	Recruiting
Vantage Clinical Trials	Tampa	Florida	33709	Recruiting
Injury Care Family Care Research	Boise	Idaho	83709	Terminated
Axis Spine Center	Post Falls	Idaho	83854	Recruiting
Indiana Spine Group	Carmel	Indiana	46032	Recruiting
Norton Leatherman Spine Center	Louisville	Kentucky	40202	Recruiting
Ochsner Health System	New Orleans	Louisiana	70121	Recruiting
Mayo Clinic (MN)	Rochester	Minnesota	55905	Recruiting
The Orthopedic Center of St. Louis	St Louis	Missouri	63141	Recruiting
Weill Cornell Medicine for Comprehensive Spine Care	New York	New York	10022	Recruiting
Wake Research	Wilmington	North Carolina	28403	Recruiting
Carolinas Pain Institute/ Center For Clinical Research	Winston-Salem	North Carolina	27103	Recruiting
Cleveland Clinic	Cleveland	Ohio	10524	Recruiting
Pacific Sports and Spine	Eugene	Oregon	97404	Recruiting
Main Line Spine	King of Prussia	Pennsylvania	19406	Recruiting
Semmes Murphey Neurological Clinic	Memphis	Tennessee	38120	Recruiting
Pain Specialists of America	Austin	Texas	78745	Recruiting
University of Utah	Salt Lake City	Utah	84108	Recruiting
Virginia iSpine Physicians	Richmond	Virginia	23238	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07254806, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 3, 2026 · Synced Sep 4, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07254806 live on ClinicalTrials.gov.

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