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Degenerative Disc DiseasePhase 3IDCTNCT07254806

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

A Phase 3 study testing IDCT (rebonuputemcel) in people with Degenerative Disc Disease, run by DiscGenics, Inc. at 31 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Degenerative Disc Disease
What is being tested?
IDCT (rebonuputemcel)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
31 sitesUnited States
Study dates
23 Dec 2025to 24 Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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).-

Who cannot join

  • 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.
Show all 49Show fewer
  • 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.
  • 31. 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.
  • 32. Is at higher risk for post-surgical infection (e.g., taking immunosuppressants), has a severe infection or a history of serious infection.
  • 33. Has concomitant conditions requiring daily oral steroid usage for more than 30 days in the preceding 90 days before Screening.
  • 34. 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
  • 35. Has a history of unexplained, easy, or persistent bruising or bleeding, bleeding from the gums, or bleeding problems experienced in previous surgical procedures.
  • 36. Has a history of hypersensitivity or anaphylactic reaction to bovine products, sodium hyaluronate/ hyaluronan/ hyaluronic acid, gentamicin, amphotericin b, dimethyl sulfoxide (DMSO), crustaceous/ shellfish, or porcine products.
  • 37. Has an uncontrolled psychiatric condition or substance/alcohol abuse that would potentially interfere with the subject's participation in the study within 2 years prior to Screening in the opinion of the Investigator.
  • 38. Has positive serum pregnancy test or nursing at time of Screening or has plans to become pregnant within the planned length of the study (2 years).
  • 39. Has a body habitus that precludes adequate fluoroscopic visualization for the procedure or the procedure is physically impossible.
  • 40. Has or requires an implantable electronic defibrillator, pacemaker, or has other contraindication to MRI scanning or cannot tolerate MRI scanning. Subjects who are expected to require a defibrillator or pacemaker, as determined by the Investigator should be excluded.
  • 41. Has participated in another clinical study within the 6 months prior to Screening.
  • 42. Has been a recipient or plans to be a recipient during trial participation of stem cell product to treat the lumbar spine.
  • 43. Has participated in a prior IDCT clinical study.
  • 44. Has pending litigation against a health care professional, except where required by the insurer as a condition of coverage.
  • 45. A person who would not be available for the entire planned length of the trial.
  • 46. Has active or pending worker's compensation claims. 47. In the Investigators opinion, the subject is not suitable for participation in the clinical trial.
  • Imaging Exclusion Criteria:
  • 48. Three discs (L3-S1) that have a Modified Pfirrmann Grade 4-7.
  • 49. Has evidence of prior lumbar vertebral body fracture at L3-S1.
  • 50. Has scoliosis with curvature > 10 degrees.
  • 51. Has congenital spinal irregularities such as segmentation.
  • 52. Has an acute fracture of the spine at the time of enrollment in the study. Clinically compromised vertebral bodies within L3-S1 due to current or past trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae.
  • 53. Has evidence of dynamic instability on lumbar flexion extension per screening radiographs as indicated by >4.5 mm of translational motion at L3-S1; >15° of angular motion at L3/-L4; >20° of angular motion at L4-L/5; or >25° angular motion at L5/-S1.
  • 54. Has Grade 2 or higher spondylolisthesis at L3-S1, as assessed by Meyerding classification.
  • 55. Has lumbar spondylitis or other undifferentiated spondyloarthropathy.
  • 56. Has Modic Type III Changes at L3-S1.
  • 57. Has radiographic evidence or suspicion of a full thickness annular tear at L3-S1.
  • 58. Has evidence of abnormal disc morphology defined as an extrusion or sequestration according to Fardon classification at L3- S1.
  • 59. Has herniation > 3 mm in AP dimension that is associated with nerve root compression.

Trial locations and contacts

31 sites in 1 country. Contact the study team or a site near you to ask about taking part.

31 sites in 1 country

United States31 sites, 30 recruiting

  • Pain Specialists of America

    Austin, Texas, 78745

    Sheila Nardelli, 949-922-5785, sheila@researchtex.com

    Genaro Gutierrez, MD

    Recruiting

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

    Bailey Luster, 205-833-2228, bailey.murphy@actstudy.net

    Brad 205-833-2228, MD

    Recruiting

  • Injury Care Family Care Research

    Boise, Idaho, 83709

    Terminated

  • Indiana Spine Group

    Carmel, Indiana, 46032

    Sheetal Vinayek, 317-715-5897, svinayek@indianaspinegroup.com

    Kevin Macadaeg, MD

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Reehan Malhance, 312.942.0512, Reehan_T_Malhance@rush.edu

    John O'Toole, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 10524

    Heather Rogers, 216-444-1292, ROGERSH3@ccf.org

    Jijun Xu, MD

    Recruiting

  • Pacific Sports and Spine

    Eugene, Oregon, 97404

    Ashley Hamann, 541-780-0355, ahamann@pacificsportsandspine.com

    Gregory Moore, MD

    Recruiting

  • Mayo Clinic (FL)

    Jacksonville, Florida, 32224

    Katie Siebenlar, 904-953-4915, siebenaler.katie@mayo.edu

    Wenchun Qu, MD

    Recruiting

  • Main Line Spine

    King of Prussia, Pennsylvania, 19406

    Cheryl Pugh, 610-337-3111, cherylp@mainlinespine.com

    Scott Davidoff, MD

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Lisa Richardson, 501-526-7664, Lrichardson3@uams.edu

    Erica Petersen, MD

    Recruiting

  • Norton Leatherman Spine Center

    Louisville, Kentucky, 40202

    Morgan Brown, 502-584-7525, morgan.brown2@nortonhealthcare.org

    Steven Glassman, MD

    Recruiting

  • Semmes Murphey Neurological Clinic

    Memphis, Tennessee, 38120

    Study Coordinator, 901-260-6111, cberryman@semmes-murphey.com

    901-259-5319, jarnold@semmes-murphey.com

    Recruiting

  • University of Miami Health System

    Miami, Florida, 33136

    Yamilet Nieves Nieves, 305-243-3048, yxn176@med.miami.edu

    Barth Green, MD

    Recruiting

  • Ochsner Health System

    New Orleans, Louisiana, 70121

    Raquel Walker, 504-703-6091, raquel.walker@ochsner.org

    Maged Guirguis, MD

    Recruiting

  • Weill Cornell Medicine for Comprehensive Spine Care

    New York, New York, 10022

    Jeffery Tan, 888-922-2257, jet4014@med.cornell.edu

    Prabhav Deo, MD

    Recruiting

  • Conquest Research

    Orlando, Florida, 32832

    Kendra Tandeski, 689-488-9112, kendra.tandeski@conquestresearch.com

    Gilbert Mbeo, MD

    Recruiting

  • Mayo Clinic (AZ)

    Phoenix, Arizona, 85054

    Debbie Ryan, 480-342-1208, Ryan.Debra29@mayo.edu

    John Freeman, MD

    Recruiting

  • Axis Spine Center

    Post Falls, Idaho, 83854

    Study Coordinator, 208-457-4208, elisa.maples@nwsh.com

    Katelyn.Chemodurow@NWSH.com

    Recruiting

  • Virginia iSpine Physicians

    Richmond, Virginia, 23238

    Devon Withers, 804-330-2611, crc2@vaispine.com

    Michael DePalma, MD

    Recruiting

  • Mayo Clinic (MN)

    Rochester, Minnesota, 55905

    Rose Decker, 507-422-0584, decker.rose@mayo.edu

    Ryan D'Souza, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84108

    Tou Xiong, 801-587-5341, Tou.Xiong@hsc.utah.edu

    Zachary McCormick, MD

    Recruiting

  • Solaris Research Institute

    San Diego, California, 92111

    Michelle Yi, 858-251-6420, myi@solarisresearchinstitute.com

    Krishnan Chakravarthy, MD

    Recruiting

  • Source Healthcare

    Santa Monica, California, 90403

    Nidhi Thati, 310-574-2777, nidhi@sourcehealthcare.com

    Timothy Davis, MD

    Recruiting

  • HonorHealth

    Scottsdale, Arizona, 85251

    Helen Riahi, 602-258-2863, hriahi@honorhealth.com

    Luis Tumialan, MD

    Recruiting

  • The Orthopedic Center of St. Louis

    St Louis, Missouri, 63141

    Study Coordinator, 314-738-4822, fschranck@spirittresearch.com

    Matthew Gornet, MD

    Recruiting

  • Vantage Clinical Trials

    St. Petersburg, Florida, 33709

    Civahn Robinson, 727-471-6226, crobinson@vantagetrials.com

    Robert Guirguis, MD

    Recruiting

  • Vantage Clinical Trials

    Tampa, Florida, 33709

    Yiset Sanchez, 813-549-5262, ysanchez@vantagetrials.com

    Jorge Leal, MD

    Recruiting

  • Pain Management and Injury Relief

    Thousand Oaks, California, 91320

    Yvonne Avila, 877-972-7576, yvonne.avila@sclamanagement.com

    Alexander Hersel, MD

    Recruiting

  • International Spine, Pain and Performance Center

    Washington D.C., District of Columbia, 20006

    Sydney Sheridan, 202-808-8295, ssheridan@isppcenter.com

    Mehul Desai, MD

    Recruiting

  • Wake Research

    Wilmington, North Carolina, 28403

    Study Coordinator, 919-645-9212, dmyers@wakeresearch.com

    Jeremy Hoff, MD

    Recruiting

  • Carolinas Pain Institute/ Center For Clinical Research

    Winston-Salem, North Carolina, 27103

    Study Coordinator, 336-765-6181 ext. ext 146, jbrewer@ccrpain.com

    Christopher Gilmore, MD

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read more

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)
Read the detailed description

Adult subjects with a diagnosis of single-level, mild to moderate, symptomatic lumbar (L3-S1) intervertebral disc degeneration that give consent and meet all the inclusion criteria and none of the exclusion criteria will be enrolled in this study. The disease, single-level disc will be known as the 'target disc' and will be either L3/L4, L4/L5, or L5/S1.

Being tested
IDCT (rebonuputemcel), Sham (No Treatment)
Keywords
DDD, low back pain, degenerative disc disease
Medical subject headings
Intervertebral Disc Degeneration, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDCT (rebonuputemcel)Biological

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

  • Sham (No Treatment)Other

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

Study groups in NCT07254806
Study groupRoleWhat they receive
IDCT (n=108); Intradiscal injection of IDCT in a single target discExperimental1 mL intradiscal injection of 9,000,000 cells/mL
Receives: Biological: IDCT (rebonuputemcel)
Sham (n=54);Sham comparatorNeedle insertion up to the annulus of a single target disc.
Receives: Other: Sham (No Treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 52

  2. 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).

    Measured: Week 52

  3. Adverse Events

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

    Measured: Day 1 to Week 52 in each treatment group.

  4. 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.

    Measured: Day 1 to Week 52 in each treatment group

Secondary outcomes (9)

  1. Visual Analogue Scale (VAS)

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

    Measured: Week 4, 12 and 26, 78 and 104

  2. 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).

    Measured: Week 4, 12 and 26, 78 and 105

  3. EQ-5D

    EQ-5D is a validated too consisting of a set of questions covering five dimensions, with each dimension having a different severity level.

    1. Mobility: Ranging from "no problems walking about" to "confined to bed". Self-care: Ranging from "no problems with self-care" to "unable to wash or dress myself".
    2. Usual activities: Ranging from "no problems doing my usual activities" to "unable to do my usual activities" (e.g., work, study, housework).
    3. Pain/discomfort: Ranging from "no pain or discomfort" to "extreme pain or discomfort".
    4. Anxiety/depression: Ranging from "not anxious or depressed" to "extremely anxious or depressed".
    5. Visual Analog Scale (EQ VAS): A scale (typically 0-100) where respondents mark their overall health from "worst imaginable" to "best imaginable".

    Measured: Enrollment through Week 104

  4. Disc Volume

    MRI assessment of Disc Volume though Week 104

    Measured: Day 1 to Week 104

  5. Pain Medication Use

    Concomitant pain medication use for low back pain related to the target disc

    Measured: Enrollment to Week 104

  6. Concomitant Therapy

    Concomitant medical therapy for low back pain (physical therapy, acupuncture, chiropractic manipulation, massage, and at-home, medically supervised exercise program etc.) use for low back pain

    Measured: Enrollment to Week 104

  7. Treatment Failure Rate

    Treatment failure rate (defined as an invasive non-surgical or surgical intervention) directly related to the target disc.

    Measured: Enrollment to week 104

  8. Adverse Events

    The incidence of grade 2 (moderate) or greater AEs and SAEs

    Measured: Enrollment to Week 104

  9. Adverse Events of Special Interest (AESI)

    The incidence of Adverse Events of Special Interest (AESI) observed defined as any one of the followings symptomatic injury of the target disc including annular tear, disc, herniation/extrusion/prolapse or any case of discitis.

    Measured: Enrollment to Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start23 Dec 2025
  3. Primary completion24 Nov 2027 (estimated)
  4. Study completion24 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07254806
Sponsor's protocol ID
DGX-A02
Acronym
IDCT
Status last verified
Oct 2026
First submitted
17 Nov 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IDCT (rebonuputemcel) in people with Degenerative Disc Disease, run by DiscGenics, Inc. at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) for low back pain (time frame: Week 52). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07254806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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