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

NCT07254806 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: DGX-A02
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 14

Brief 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)

Conditions

Degenerative Disc Disease

Keywords

DDD; low back pain; degenerative disc disease

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale (VAS) for low back pain

  VAS is a sliding visual scale of 0 being "no pain" and 100 being "worst pain Imaginable' to assess changesfrom baseline in low back pain compared to Sham

  Week 52

• Oswestry Disability Index (ODI)

  ODI is a 10-item questionnaire used to measure functional disability in people with low back pain. It is a self-administered tool that assesses how back pain affects daily activities like walking, sleeping, and personal hygiene, with scores ranging from 0% (no disability) to 100% (maximum disability).

  Week 52

• Adverse Events

  Incidence of grade 2 (moderate) or greater AEs and SAEs

  Day 1 to Week 52 in each treatment group.

• Adverse events of special interest

  Incidence of Adverse Events of Special Interest (AESI) to include any symptomatic injury of the target disc including annular tear, disc herniation/extrusion/prolapse as well as discitis.

  Day 1 to Week 52 in each treatment group

Secondary Outcomes (9)

• Visual Analogue Scale (VAS)

  Week 4, 12 and 26, 78 and 104

• Oswestry Disability Index (ODI)

  Week 4, 12 and 26, 78 and 105

• EQ-5D

  Enrollment through Week 104

• Disc Volume

  Day 1 to Week 104

• Pain Medication Use

  Enrollment to Week 104

Other Outcomes (2)

• MRI Based evaluations

  Enrollment through Week 104

• X-ray evaluation of the lumbar spine

  Screening through Week 104

Study Arms (2)

IDCT (n=108); Intradiscal injection of IDCT in a single target disc

EXPERIMENTAL

1 mL intradiscal injection of 9,000,000 cells/mL

Biological: IDCT (rebonuputemcel)

Sham (n=54);

SHAM COMPARATOR

Needle insertion up to the annulus of a single target disc.

Other: Sham (No Treatment)

Interventions

IDCT (rebonuputemcel) BIOLOGICAL

Single intradiscal injection of 1 mL of 9,000,000 cells/mL IDCT in a single target disc.

IDCT (n=108); Intradiscal injection of IDCT in a single target disc

Sham (No Treatment) OTHER

Single Sham needle insertion up to the annulus of a single target disc.

Sham (n=54);

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• DiscGenics, Inc.: lead

Study Sites (14)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

RECRUITING

Source Healthcare

Santa Monica, California, 90403, United States

RECRUITING

Vantage Clinical Trials

St. Petersburg, Florida, 33709, United States

RECRUITING

Vantage Clinical Trials

Tampa, Florida, 33709, United States

RECRUITING

Injury Care Family Care Research

Boise, Idaho, 83709, United States

RECRUITING

Axis Spine Center

Post Falls, Idaho, 83854, United States

RECRUITING

Indiana Spine Group

Carmel, Indiana, 46032, United States

RECRUITING

The Orthopedic Center of St. Louis

St Louis, Missouri, 63141, United States

RECRUITING

Wake Research

Wilmington, North Carolina, 28403, United States

RECRUITING

Carolinas Pain Institute/ Center For Clinical Research

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Pacific Sports and Spine

Eugene, Oregon, 97404, United States

RECRUITING

Semmes Murphey Neurological Clinic

Memphis, Tennessee, 38120, United States

RECRUITING

Pain Specialists of America

Austin, Texas, 78745, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Flood

  DiscGenics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All parties in this trial will be blinded with the exception of the unblinded injecting sub-investigator and their team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 28, 2025
• Study Start: December 23, 2025
• Primary Completion (Estimated): November 24, 2027
• Study Completion (Estimated): November 24, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (14)