Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration

• Status: Active, not recruiting
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and two controls (saline, Sodium Hyaluronate vehicle) in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DiscGenics, Inc.
• Treatments: Hyaluronic Acid; Pharmaceutical Solutions

Criteria

Inclusion Criteria: The subject must have:

1. Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7.

2. Chronic low-back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care.

3. Low-back pain of 40 to 90 mm on the VAS and ODI score of 30 to 90.

Exclusion Criteria: The subject is excluded if he/she has:

1. Symptomatic involvement of more than one lumbar disc.

2. Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.

3. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc.

4. Evidence of dynamic instability on lumbar flexion-extension radiographs.

5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc.

6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology.

7. Clinical suspicion of facet pain as primary pain generator.

8. Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection.

9. Patients who are deemed unsuitable for clinical study participation by the investigator.