Trial · NCT07254806
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, Phase 3, Recruiting, DiscGenics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease. Trials, record NCT07254806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07254806
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease
- NCT number
- NCT07254806
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 162 participants, estimated
- Lead sponsor
- DiscGenics, Inc.
- Conditions
- Degenerative Disc Disease
- Interventions
- IDCT (rebonuputemcel), Sham (No Treatment)
- First posted
- 2025-11-28
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Analogue Scale (VAS) for low back pain | Week 52 | 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 |
| Primary | Oswestry Disability Index (ODI) | Week 52 | ODI is a 10-item questionnaire used to measure functional disability in people with low back pain. It is a self-administered tool that assesses how back pain affects daily activities like walking, sleeping, and personal hygiene, with scores ranging from 0% (no disability) to 100% (maximum disability). |
| Primary | Adverse Events | Day 1 to Week 52 in each treatment group. | Incidence of grade 2 (moderate) or greater AEs and SAEs |
| Primary | Adverse events of special interest | Day 1 to Week 52 in each treatment group | Incidence of Adverse Events of Special Interest (AESI) to include any symptomatic injury of the target disc including annular tear, disc herniation/extrusion/prolapse as well as discitis. |
| Secondary | Visual Analogue Scale (VAS) | Week 4, 12 and 26, 78 and 104 | VAS is a sliding visual scale of 0 being "no pain" and 100 being "worst pain Imaginable' to assess changes from baseline in low back pain |
| Secondary | Oswestry Disability Index (ODI) | Week 4, 12 and 26, 78 and 105 | ODI is a 10-item questionnaire used to measure functional disability in people with low back pain. It is a self-administered tool that assesses how back pain affects daily activities like walking, sleeping, and personal hygiene, with scores ranging from 0% (no disability) to 100% (maximum disability). |
| Secondary | EQ-5D | Enrollment through Week 104 | EQ-5D is a validated too consisting of a set of questions covering five dimensions, with each dimension having a different severity level. 1. Mobility: Ranging from "no problems walking about" to "confined to bed". Self-care: Ranging from "no problems with self-care" to "unable to wash or dress myself". 2. Usual activities: Ranging from "no problems doing my usual activities" to "unable to do my usual activities" (e.g., work, study, housework). 3. Pain/discomfort: Ranging from "no pain or discomfort" to "extreme pain or discomfort". 4. Anxiety/depression: Ranging from "not anxious or depressed" to "extremely anxious or depressed". 5. Visual Analog Scale (EQ VAS): A scale (typically 0-100) where respondents mark their overall health from "worst imaginable" to "best imaginable". |
| Secondary | Disc Volume | Day 1 to Week 104 | MRI assessment of Disc Volume though Week 104 |
| Secondary | Pain Medication Use | Enrollment to Week 104 | Concomitant pain medication use for low back pain related to the target disc |
| Secondary | Concomitant Therapy | Enrollment to Week 104 | Concomitant medical therapy for low back pain (physical therapy, acupuncture, chiropractic manipulation, massage, and at-home, medically supervised exercise program etc.) use for low back pain |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07254806
GET https://conductscience.org/api/trials/v1/NCT07254806/registered