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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
Led by DiscGenics, Inc. · Updated on 2026-04-21
162
Participants Needed
14
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a treatment called Intradiscal Cell Therapy (IDCT) for adults with mild to moderate, symptomatic lumbar degenerative disc disease affecting a single disc level between L3 and S1. This Phase III study compares IDCT to a sham procedure in a randomized, double-blinded, controlled trial involving about 162 participants. The study includes a 52-week primary period followed by another 52-week follow-up, totaling 104 weeks. Participants will be randomly assigned in a 2:1 ratio to receive either a single injection of IDCT containing 9 million cells per mL into the target disc or a sham needle insertion without active treatment. The injection is given as a 1 mL dose directly into the affected disc. Screening includes MRI and X-ray imaging to confirm eligibility and the location of disc degeneration. Randomization occurs 7 to 14 days before treatment. Throughout the study, participants will undergo assessments including pain measurement using the Visual Analogue Scale and disability evaluation with the Oswestry Disability Index at multiple time points up to two years. Researchers will also monitor adverse events and other health outcomes, including quality of life, disc volume changes, medication use, and treatment failure rates. The study involves informed consent, regular visits, and imaging to ensure safety and collect data.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of mild to moderate, symptomatic single-level degenerative disc disease (DDD) from L3 to S1.
- Target disc with Modified Pfirrmann Grade 3-7 as confirmed by central radiologist.
- Age between 18 and 75 years, skeletally mature.
- Body mass index (BMI) between 18 kg/m2 and 38 kg/m2 at screening.
- Chronic low back pain lasting at least 6 months before screening.
- Low back pain not improved after at least 3 months of conservative treatment including physical therapy and medications.
- Pre-treatment low back pain score between 45 and 90 on Visual Analogue Scale (VAS) at screening and Day 1.
- Pre-treatment Oswestry Disability Index (ODI) score between 35 and 90 at screening and Day 1.
- Willing to sign informed consent and allow release of medical history.
- Physically and mentally able to follow study protocol and complete forms.
- Female subjects of childbearing potential must agree to use effective birth control during the study.
You will not qualify if you...
- Low back pain mainly due to muscle pain as judged by investigator.
- Constant low back pain not affected by different spinal positions.
- Radiculopathy caused by nerve compression.
- Leg pain greater than 50% intensity of low back pain or radicular leg pain.
- Frequent leg pain extending below the knee.
- Severe osteoarthritis of knee or hip.
- Severe spinal arthritis or cauda equina syndrome.
- Previous lumbar spine surgery or invasive disc treatments within 3 months before screening.
- Prior basivertebral nerve ablation at L3-S1.
- Suspected facet joint pain as main pain source.
- Current or past infections at procedure site or lumbar spine infections.
- History of fibromyalgia.
- Positive test for Hepatitis B, Hepatitis C, or HIV.
- Active or recent malignancy except basal cell skin cancer.
- Significant systemic disease or coagulopathy.
- Taking certain anticoagulant or antineoplastic medications that cannot be stopped.
- High risk of infection or recent serious infection.
- Daily oral steroid use over 30 days in past 90 days.
- Opioid use above specified thresholds.
- History of bleeding disorders or allergic reactions to related products.
- Uncontrolled psychiatric conditions or substance abuse.
- Positive pregnancy test, nursing, or plans to become pregnant.
- Body habitus preventing procedure or MRI contraindications.
- Participation in another clinical study within 6 months.
- Prior participation in IDCT studies or stem cell treatments for lumbar spine.
- Pending litigation against healthcare professional.
- Unavailability for entire study duration.
- Active or pending worker's compensation claims.
- Imaging exclusions including multiple degenerated discs, spinal fractures, scoliosis >10 degrees, spinal irregularities, fractures, dynamic instability, spondylolisthesis Grade 2 or higher, spondyloarthropathy, specific Modic changes, annular tears, disc extrusion or sequestration, and herniation causing nerve compression.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants receive a single injection of either IDCT cells or a sham needle insertion in the target lumbar disc.
1 treatment visit (in-person)
Duration - Up to 104 weeks
Participants are monitored for safety and efficacy through various assessments including pain scales and disability indexes.
Visits at Week 4, 12, 26, 52, 78, and 104 (in-person or remote)
Trial Site Locations
Total: 14 locations
1
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Actively Recruiting
2
Source Healthcare
Santa Monica, California, United States, 90403
Actively Recruiting
3
Vantage Clinical Trials
St. Petersburg, Florida, United States, 33709
Actively Recruiting
4
Vantage Clinical Trials
Tampa, Florida, United States, 33709
Actively Recruiting
5
Injury Care Family Care Research
Boise, Idaho, United States, 83709
Actively Recruiting
6
Axis Spine Center
Post Falls, Idaho, United States, 83854
Actively Recruiting
7
Indiana Spine Group
Carmel, Indiana, United States, 46032
Actively Recruiting
8
The Orthopedic Center of St. Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
9
Wake Research
Wilmington, North Carolina, United States, 28403
Actively Recruiting
10
Carolinas Pain Institute/ Center For Clinical Research
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
11
Pacific Sports and Spine
Eugene, Oregon, United States, 97404
Actively Recruiting
12
Semmes Murphey Neurological Clinic
Memphis, Tennessee, United States, 38120
Actively Recruiting
13
Pain Specialists of America
Austin, Texas, United States, 78745
Actively Recruiting
14
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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