Degenerative Disc Disease
Conditions
Keywords
Lumbar disc degeneration, Low back pain, Intervertebral disc degeneration
Brief 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.
Detailed description
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). 8 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26, week 52, 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).
Interventions
BIOLOGICALIDCT
Discogenic Cells + Sodium Hyaluronate Vehicle
DRUGSaline Solution
Sodium Chloride Solution
DRUGSodium Hyaluronate
Sodium Hyaluronate Vehicle
Sponsors
CTI Clinical Trial and Consulting Services
DiscGenics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as measured by number of Adverse Events | 2 Years | 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 grade 2 or greater AEs and SAEs observed from Day 1 to week 104 |
| Efficacy (Pain) | 1 Year | Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS). 0: no pain, 100: worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability | 2 Years | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory | 2 Years | Imaging parameters will be evaluated via radiological evaluations |
Countries
United States
Outcome results
None listed