Actively Recruiting
Phase 3 Study to Test Safety and Effectiveness of IDCT Cell Therapy for Adults With Mild to Moderate Single-Level Lumbar Disc Degeneration
Led by DiscGenics, Inc. · Updated on 2026-08-07
162
Participants Needed
24
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the safety and effectiveness of Intradiscal Cell Therapy IDCT compared to a Sham procedure for adults aged 18 to 75 with mild to moderate symptomatic degenerative disc disease at a single lumbar level L3-S1. The study is a Phase III, randomized, double-blinded, sham-controlled, multicenter trial involving 162 participants. The target disc is identified by imaging and must meet specific grading criteria, with participants experiencing chronic low back pain unresponsive to conservative treatments. Participants will be randomly assigned in a 21 ratio to receive either a single intradiscal injection of 9 million cells in 1 mL IDCT or a Sham needle insertion up to the annulus of the target disc. The target disc is one of L3L4, L4L5, or L5S1. Randomization occurs 7 to 14 days before treatment. The study includes a 52-week primary evaluation period followed by an additional 52-week follow-up, totaling 104 weeks for monitoring. Throughout the study, participants will undergo baseline and follow-up assessments including MRI and X-ray imaging, Visual Analogue Scale VAS for low back pain, Oswestry Disability Index ODI, and other health and disability questionnaires. Adverse events and treatment safety will be tracked from Day 1 through Week 104. Researchers will also measure disc volume, pain medication use, and treatment failure rates while participants adhere to study protocols and visit schedules over two years.
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 from L3 to S1
- Target disc meets Modified Pfirrmann Grade 3-7 as confirmed by central radiologist
- Age between 18 and 75 years, skeletally mature
- Body mass index between 18 and 38 kg/m2 at Screening
- Chronic low back pain for at least 6 months prior to Screening
- Low back pain unresponsive to at least 3 months of conservative care including at least one non-pharmacological and two pharmacological interventions
- 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
- Willingness to sign informed consent and release previous medical history for study purposes
- Physically and mentally able to comply with study protocol
- Female participants of childbearing potential must agree to use highly effective birth control during the study
You will not qualify if you...
- Low back pain predominately myofascial or constant, unchanging pain not improved by position
- Presence of radiculopathy or leg pain greater than 50% intensity of low back pain
- Frequent leg pain extending below the knee
- Severe osteoarthritis of the knee or hip or severe spinal arthritis
- Cauda equina syndrome
- Previous lumbar spine surgery or invasive disc treatments within 3 months prior to Screening
- Basivertebral nerve ablation at L3-S1
- Clinical suspicion of facet joint pain as primary pain source
- Current or prior lumbar spinal infection or active infection at procedure site
- History of fibromyalgia
- Positive for Hepatitis B, Hepatitis C, or HIV
- Active or recent malignancy within 5 years (except basal cell skin cancer)
- Significant systemic disease, unstable angina, autoimmune disease, coagulopathy, or thrombocytopenia
- Use of certain anticoagulant or antineoplastic medications not safely withheld
- High risk for post-surgical infection or recent serious infection
- Daily oral steroid use for more than 30 days in past 90 days
- Opioid use exceeding specified dosages
- History of bleeding disorders or hypersensitivity to study-related products
- Uncontrolled psychiatric condition or substance abuse within 2 years
- Positive pregnancy test, nursing, or plans to become pregnant during study
- Body habitus or implanted devices preventing safe MRI or procedure
- 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 or active worker's compensation claims
- Not available for entire trial duration or deemed unsuitable by Investigator
- Imaging exclusions including scoliosis over 10 degrees, spinal fractures, dynamic instability, spondylolisthesis grade 2 or higher, Modic changes, annular tears, extrusion or sequestration of disc, and herniation causing nerve compression
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