IDCT for Degenerative Disc Disease

(IDCT Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: DiscGenics, Inc.

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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

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)

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+