Actively Recruiting
A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease
Led by DiscGenics, Inc. · Updated on 2026-04-21
162
Participants Needed
14
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official 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...
- Diagnosed with mild to moderate, symptomatic, single-level degenerative disc disease from L3 to S1
- Target disc graded Modified Pfirrmann Grade 3-7 by central radiologist
- Aged 18 to 75 years, skeletally mature, BMI between 18 and 38 kg/m2
- Chronic low back pain for at least 6 months before screening
- Low back pain unresponsive to at least 3 months of nonoperative care including at least one non-drug and two drug treatments
- Pre-treatment low back pain score of 45 to 90 on Visual Analogue Scale at screening and Day 1
- Pre-treatment Oswestry Disability Index score of 35 to 90 at screening and Day 1
- Willing to sign informed consent and release medical history
- Physically and mentally able to comply with study protocol
- Female subjects of childbearing potential agree to use highly effective birth control during the study
You will not qualify if you...
- Low back pain considered mainly myofascial or constant and unchanging
- Radiculopathy caused by nerve compression
- Leg pain more intense than back pain or extending below the knee
- Severe osteoarthritis of knees or hips
- Severe spinal arthritis or cauda equina syndrome
- Previous lumbar spine surgery or invasive disc treatments within 3 months
- Previous basivertebral nerve ablation at L3-S1
- Clinical suspicion of facet pain as main pain source
- Current or past lumbar spinal infections
- History of fibromyalgia
- Positive for Hepatitis B, Hepatitis C, or HIV
- Active or recent malignancy except basal cell skin cancer
- Significant systemic diseases or coagulopathy
- Use of anticoagulant or antineoplastic medications not safely withheld
- High risk or history of serious infections
- Daily oral steroid use for more than 30 days in past 90 days
- Opioid use exceeding specified limits
- History of bleeding or allergic reactions to study product components
- Uncontrolled psychiatric or substance abuse conditions
- Pregnancy, nursing, or plans for pregnancy during study
- Body habitus or implants preventing MRI or procedure
- Participation in other clinical trials within 6 months
- Prior or planned stem cell treatment for lumbar spine
- Pending litigation or worker's compensation claims
- Imaging findings including multiple severe degenerated discs, prior fractures, scoliosis over 10 degrees, spinal irregularities, instability, spondylolisthesis, spondylitis, Modic changes, annular tears, abnormal disc morphology, or herniations causing nerve compression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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