A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Degenerative Disc Disease

In brief

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)

Key facts

Study ID: NCT07254806
Run by: DiscGenics, Inc.
People needed: 162
Starts: 2025-12-23
Expected to finish: 2028-11-24
Last updated by the study team: 2026-08-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
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.
Is physically and mentally able to comply with the protocol, able to understand and complete the required forms, and willing and able to adhere to the requirements of the protocol in the opinion of the Investigator.
Female-born subjects of childbearing potential must agree to and comply with using highly effective methods of birth control for the duration of the study (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, condoms, or a vasectomized partner).-

You may not qualify if…

Physical/ Medical History Exclusion Criteria
Has low back pain that in the Investigator's opinion is predominately myofascial in nature.
Has constant, unchanging low back pain that is not improved in any spinal position.
Has radiculopathy resulting from nerve compression.
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.
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.
Has frequent leg pain that extends below the knee.
Has severe unilateral or bilateral osteoarthritis of the knee or hip.
Severe spinal arthritis
Has cauda equina syndrome.
Has had previous lumbar spine surgery.
Has had previous disc invasive treatment procedures (i.e., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation) or intradiscal injections (i.e., injection of corticosteroids, methylene blue, dextrose, or glucosamine and chondroitin sulfate) or diagnostic discography at L3-S1 within the 3 months prior to Screening.
Subjects who have had basivertebral nerve ablation at L3-S1.
Has clinical suspicion of facet pain as the primary pain generator.
Has current infection at the planned procedure site, active systemic infection, or current or prior history of lumbar spinal infection (i.e., discitis, septic arthritis, epidural abscess).
Has a history of fibromyalgia.
Has tested positive for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human Immunodeficiency Virus (HIV).
Has presence of an active malignancy or tumor, or a prior history of malignancy within the last five years (except for basal cell carcinoma of the skin).
Has presence or prior history of a spinal malignancy.
Has significant systemic disease, such as unstable angina or autoimmune disease, such as rheumatoid arthritis. Has a history of congenital or acquired coagulopathy or thrombocytopenia.
Is currently taking anticoagulant, antiplatelet, or thrombolytic medications (except for aspirin or nonsteroidal anti-inflammatory drugs [NSAIDS]) and at the Investigator's medical discernment and discretion is unable to withhold medications for the time required per site standard or care, prior to the IDCT injection or is taking antineoplastic medications.
Is at higher risk for post-surgical infection (e.g., taking immunosuppressants), has a severe infection or a history of serious infection.
Has concomitant conditions requiring daily oral steroid usage for more than 30 days in the preceding 90 days before Screening.
Is taking opioids greater than 20 MME per day on an intermittent (as needed) basis OR is taking 20 MME or greater daily for more than 3 months prior to Screening
Has a history of unexplained, easy, or persistent bruising or bleeding, bleeding from the gums, or bleeding problems experienced in previous surgical procedures.

Where it is running

Virginia iSpine Physicians — Richmond, Virginia, United States (enrolling)
Mayo Clinic (AZ) — Phoenix, Arizona, United States (enrolling)
Solaris Research Institute — San Diego, California, United States (enrolling)
Source Healthcare — Santa Monica, California, United States (enrolling)
Pain Management and Injury Relief — Thousand Oaks, California, United States (enrolling)
International Spine, Pain and Performance Center — Washington D.C., District of Columbia, United States (enrolling)
Mayo Clinic (FL) — Jacksonville, Florida, United States (enrolling)
Conquest Research — Orlando, Florida, United States (enrolling)
Vantage Clinical Trials — St. Petersburg, Florida, United States (enrolling)
Vantage Clinical Trials — Tampa, Florida, United States (enrolling)
Alabama Clinical Therapeutics — Birmingham, Alabama, United States (enrolling)
Axis Spine Center — Post Falls, Idaho, United States (enrolling)
Indiana Spine Group — Carmel, Indiana, United States (enrolling)
Mayo Clinic (MN) — Rochester, Minnesota, United States (enrolling)
The Orthopedic Center of St. Louis — St Louis, Missouri, United States (enrolling)
Weill Cornell Medicine for Comprehensive Spine Care — New York, New York, United States (enrolling)
Wake Research — Wilmington, North Carolina, United States (enrolling)
Carolinas Pain Institute/ Center For Clinical Research — Winston-Salem, North Carolina, United States (enrolling)
Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
Pacific Sports and Spine — Eugene, Oregon, United States (enrolling)
Semmes Murphey Neurological Clinic — Memphis, Tennessee, United States (enrolling)
Pain Specialists of America — Austin, Texas, United States (enrolling)
University of Utah — Salt Lake City, Utah, United States (enrolling)
Injury Care Family Care Research — Boise, Idaho, United States

Full record on ClinicalTrials.gov

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