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

This is a Phase I, first‑in‑human, randomized, double‑blind, vehicle and placebo-controlled,
parallel‑group, multi-center study in subjects with single‑level, symptomatic lumbar
intervertebral disc degeneration (>6 months) and unresponsive to conservative therapy for at
least 3 months. The study will compare single intradiscal injections of high and low dose
IDCT with two control groups (saline, Sodium Hyaluronate).

7 study visits will be completed by all subjects; screening, day 1 (injection day), week 4,
week 12, week 26, week 72 and week 104. The subject will be assessed for safety and efficacy
utilizing VAS and ODI questionnaires alongside radiographic evaluations. The study will have
a 1 year follow-up and a 1 year extension period (total 2 years).

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