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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Discogenic Cells + Sodium Hyaluronate Vehicle
Sodium Chloride Solution
Sodium Hyaluronate Vehicle
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
UC San Diego CIRM Alpha Stem Cell Clinic
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 grade 2 or greater AEs and SAEs observed from Day 1 to week 104
Time frame: 2 Years
Efficacy (Pain)
Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS). 0: no pain, 100: worst pain imaginable.
Time frame: 1 Year
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
Time frame: 2 Years
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San Diego, California, United States
Source Healthcare
Santa Monica, California, United States
Otrimed
Edgewood, Kentucky, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
Orthopedic Center of St. Louis
Chesterfield, Missouri, United States
Ainsworth Institute of Pain Management
New York, New York, United States
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, United States
Clinical Investigations, LLC
Edmond, Oklahoma, United States
...and 4 more locations