A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Lev… (NCT07254806) | Clinical Trial Compass
RecruitingPhase 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
United States162 participantsStarted 2025-12-23
Plain-language 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)
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Has a diagnosis of mild to moderate, symptomatic, single-level degenerative disc disease (DDD) from L3-S1.
. Has a target disc that meets Modified Pfirrmann Grade 3-7, as determined by a central radiologist.
. Is ≥18 and ≤75 years of age, skeletally mature, and has a body mass index (BMI) ≥18 kg/m2 and ≤38 kg/m2 at Screening.
. Has been experiencing chronic low back pain for at least 6 months prior to Screening.
. Has had low back pain that is unresponsive to at least 3 months of conservative care (nonoperative treatment) to include at least one non-pharmacological intervention which may include physical therapy, acupuncture, chiropractic manipulation, massage, and at home medically supervised exercise program and two pharmacological interventions which may include NSAIDs, acetaminophen, duloxetine, and/or injectable therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analogue Scale (VAS) for low back pain
Timeframe: Week 52
2
Oswestry Disability Index (ODI)
Timeframe: Week 52
3
Adverse Events
Timeframe: Day 1 to Week 52 in each treatment group.
4
Adverse events of special interest
Timeframe: Day 1 to Week 52 in each treatment group
. Has pre-treatment low back pain score of 45 to 90 on VAS (Visual Analogue Scale) for low back pain at Screening and Day 1.
. Has pre-treatment ODI score of 35 to 90 at Screening and Day 1.
. Is willing to voluntarily sign the informed consent form and agrees to the release of previous medical history for purposes of this study (i.e., HIPAA authorization) at Screening.
Exclusion criteria
1. Has low back pain that in the Investigator's opinion is predominately myofascial in nature.
2. Has constant, unchanging low back pain that is not improved in any spinal position.
3. Has radiculopathy resulting from nerve compression.
4. Has non-radicular unilateral or bilateral leg pain with intensity greater than 50% of the intensity of the low-back pain, as measured by VAS.
5. Leg pain that is of radicular origin, i.e., due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces.
6. Has frequent leg pain that extends below the knee.
7. Has severe unilateral or bilateral osteoarthritis of the knee or hip.