IDCT for Degenerative Disc Disease

(IDCT Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: DiscGenics, Inc.

Must not be taking: Anticoagulants, Antiplatelets, Antineoplastics, Opioids

Disqualifiers: Radiculopathy, Severe arthritis, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

162 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IDCT (rebonuputemcel) for individuals with degenerative disc disease, a condition causing chronic lower back pain. The trial aims to determine if IDCT can reduce pain and improve mobility more effectively than a placebo procedure. Participants will receive either the IDCT treatment or a sham (fake) procedure, with their progress tracked over two years. This trial may suit individuals who have experienced persistent lower back pain for six months or more and have not found relief with other non-surgical treatments. As a Phase 3 trial, it represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking anticoagulants, antiplatelets, or thrombolytics, you may need to stop them before the treatment, except for aspirin or NSAIDs. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that IDCT (rebonuputemcel) is generally safe for people with degenerative disc disease. In earlier studies, patients who received IDCT experienced less pain and disability, with no major safety issues. Another study found that even high doses of IDCT were safe and helped increase disc size, a positive sign for treating back problems. No significant side effects were reported, indicating that most people handled the treatment well. These findings suggest that IDCT is a promising and safe option for managing back pain and improving quality of life. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for degenerative disc disease, which often include pain medication, physical therapy, or surgery, IDCT (rebonuputemcel) offers a potentially groundbreaking approach. Researchers are excited about IDCT because it involves injecting a high concentration of 9 million cells/mL directly into the degenerated disc, possibly aiding in tissue repair and regeneration. This cell-based therapy could not only alleviate pain but also address the underlying cause of the disease, offering a more comprehensive and long-lasting solution.

What evidence suggests that IDCT could be an effective treatment for degenerative disc disease?

Research shows that IDCT, a type of cell therapy, may help treat degenerative disc disease. In earlier studies, IDCT injections safely increased disc size and reduced back pain by more than 30% after one year. Patients also experienced improved movement and quality of life. In this trial, participants will receive either an intradiscal injection of IDCT or a sham procedure involving needle insertion without treatment. The treatment involves injecting special cells into the damaged disc, potentially restoring its health. Overall, these results suggest that IDCT could be a helpful option for people with this condition. ^{2 3 4 5 6}

Who Is on the Research Team?

Lisa Flood

Principal Investigator

DiscGenics, Inc.

Are You a Good Fit for This Trial?

This trial is for people with mild to moderate lumbar degenerative disc disease causing lower back pain. Participants must have symptoms at only one level of the spine between L3 and S1, confirmed by MRI and X-ray. They should not be part of any other study or have conditions that exclude them from this research.

Inclusion Criteria

Has a target disc that meets Modified Pfirrmann Grade 3-7

Has pre-treatment ODI score of 35 to 90 at Screening and Day 1

I have mild to moderate back pain due to disc disease between L3 and S1.

Exclusion Criteria

Has a history of hypersensitivity or anaphylactic reaction to certain substances

Has participated in a prior IDCT clinical study

Has tested positive for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human Immunodeficiency Virus (HIV)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 weeks

1 visit (in-person)

Treatment

Participants receive either IDCT or Sham treatment for lumbar disc degeneration

1 day

1 visit (in-person)

Primary Follow-up

Participants are monitored for safety and effectiveness, with primary outcome measured at Week 52

52 weeks

Multiple visits (in-person and virtual)

Extended Follow-up

Participants continue to be monitored for long-term safety and effectiveness

52 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• IDCT (rebonuputemcel)
• Sham (No Treatment)

Trial Overview

The trial tests IDCT (rebonuputemcel), a new cell therapy, against a sham (no treatment) in a double-blinded setup where neither participants nor researchers know who gets which treatment. It's randomized with more subjects receiving IDCT than the sham procedure over two years.

How Is the Trial Designed?

Group I: IDCT (n=108); Intradiscal injection of IDCT in a single target disc Experimental Treatment 1 Intervention

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

Group II: Sham (n=54); Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

DiscGenics, Inc.

Lead Sponsor

Trials

2

Recruited

100+

Citations

1.

discgenics.com

discgenics.com/news-posts/2023/1/23/discgenics-announces-positive-two-year-clinical-data-from-study-of-discogenic-progenitor-cell-therapy-for-degenerative-disc-disease

DiscGenics Announces Positive Two-Year Clinical Data ...

Discogenic progenitor cell therapy safely increased disc volume and provided rapid, durable improvements in low back pain, function, quality of life, and pain ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03955315

NCT03955315 | Study to Evaluate the Safety and ...

The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11535772/

Allogeneic Disc Progenitor Cells Safely Increase Disc Volume ...

The primary endpoint was mean visual analog scale (VAS) pain improvement >30% at 52 weeks. Disc volume was radiologically assessed. Adverse ...

4.

prnewswire.com

prnewswire.com/news-releases/peer-reviewed-article-reporting-discgenics-cell-therapy-phase-iii-study-results-receives-international-journal-of-spine-surgery-best-paper-award-302424175.html

Peer-Reviewed Article Reporting DiscGenics' Cell Therapy ...

"The patient outcomes from this study are very encouraging, as they show IDCT's ability to safely and effectively reduce pain and disability ...

5.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/discgenics-degenerative-disc-disease/

DiscGenics reports positive data from degenerative disc ...

Findings showed that the primary efficacy endpoint was met, with high dose IDCT arm demonstrating statistically significant improvement in back ...

6.

discgenics.com

discgenics.com/news-posts/2025/4/9/peer-reviewed-article-reporting-discgenics-cell-therapy-phase-iii-study-results-receives-international-journal-of-spine-surgery-best-paper-award

Peer-Reviewed Article Reporting DiscGenics' Cell Therapy ...

“The patient outcomes from this study are very encouraging, as they show IDCT's ability to safely and effectively reduce pain and disability ...