Study of IDCT (rebonuputemcel) for Degenerative Disc Disease
This study is looking at a treatment called IDCT (rebonuputemcel) for people with mild to moderate degenerative disc disease (DDD) in their lower back. DDD is a condition where the discs between your spinal bones wear down, causing pain. Researchers want to see if a single injection of IDCT, compared to a sham (no treatment) injection, can reduce low back pain and improve daily function. To join, you need to be between 18 and 75 years old with specific signs of DDD on an MRI. The study will measure your pain and ability to do daily activities over 52 weeks to see if the treatment is effective. The study is currently recruiting about 162 participants.
- Study design
- This is a Phase III, randomized, double-blinded study comparing IDCT to a sham treatment. Approximately 162 participants will be enrolled.
- What's involved
- You would be screened for eligibility, which includes MRI and X-ray imaging. You would receive a single injection and be followed for 52 weeks, with a total study duration of 104 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 52 weeks after treatment, with a total follow-up period of 104 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease
At a glance
Conditions
NCT07254806
Where you'd take part
This study runs at 28 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Alabama Clinical Therapeutics
Birmingham, Alabamastudy coordinator listed
Recruiting
Axis Spine Center
Post Falls, Idahostudy coordinator listed
Recruiting
Carolinas Pain Institute/ Center For Clinical Research
Winston-Salem, North Carolinastudy coordinator listed
Recruiting
Cleveland Clinic
Cleveland, Ohiostudy coordinator listed
Recruiting
Conquest Research
Orlando, Floridastudy coordinator listed
Recruiting
Indiana Spine Group
Carmel, Indianastudy coordinator listed
Recruiting
International Spine, Pain and Performance Center
Washington D.C., District of Columbiastudy coordinator listed
Recruiting
Main Line Spine
King of Prussia, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Lisa Flood · STUDY_DIRECTOR · DiscGenics, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Visual Analogue Scale (VAS) for low back painWeek 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
- 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).
- Adverse EventsDay 1 to Week 52 in each treatment group.
Incidence of grade 2 (moderate) or greater AEs and SAEs
- Adverse events of special interestDay 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.