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

Study Overview
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Brief Summary
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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 one sham control in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.

Detailed Description
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This is a Phase I/II, randomized, double-blind, sham-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 one sham control group. 6 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26 and week 52. The subject will be assessed for safety and efficacy utilizing VAS, ODI and JOABPEQ questionnaires alongside radiographic evaluations. The study will have a 6 month follow-up and a 6 month extension period (total 1 year).

Official Title
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A Randomized, Double Blind, Sham-controlled, Multi-center Phase I / II Clinical Study to Assess the Safety and Efficacy of IDCT in Patients With Lumbar Degenerative Disc Disease

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Biological: IDCT
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7. Chronic low-back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care. Low-back pain of 40 to 90 mm on the VAS ODI score of 30 to 90. Exclusion Criteria: Symptomatic involvement of more than one lumbar disc. Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, Cauda Equine syndrome, etc. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc. Evidence of dynamic instability on lumbar flexion-extension radiographs. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology. Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection. Patients who are deemed unsuitable for clinical study participation by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose IDCT<br>Single intradiscal injection with High Dose IDCT (9M cells) | Biological: IDCT<br>* Discogenic Cells + Sodium Hyaluronate Vehicle<br>* Other names: Injectable Disc Cell Therapy;|
| Experimental: Low Dose IDCT<br>Single intradiscal injection with Low Dose IDCT (3M cells). | Biological: IDCT<br>* Discogenic Cells + Sodium Hyaluronate Vehicle<br>* Other names: Injectable Disc Cell Therapy;|
| Sham Comparator: Sham<br>Sham needle puncture (outside disc) | Procedure: Sham<br>* Needle puncture under the muscular layer in front of the intervertebral disc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by number of Adverse Events | To evaluate the safety and tolerability of a single injection of IDCT in subjects with single-level, symptomatic early to moderate lumbar intervertebral disc degeneration as measured by the incidence of AEs and SAEs observed from Day 1 to week 52 | 1 year | 
| Efficacy (Pain): Visual Analogue Scale (VAS) | Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS). 0: no pain, 100: worst pain imaginable | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | Evaluate the effect of IDCT on disability as measured by the Oswestry Disability Index (ODI). Score of 0%: no disability, score of 100%: severely disabled | 1 year | 
| Efficacy (Pain): JOABPEQ | Evaluate the effect of IDCT on pain as measured by JOABPEQ. The range of the score for each domain is from 0 to 100, with higher scores indicating a better condition. | 1 year |