Status:
COMPLETED
Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration
Lead Sponsor:
DiscGenics, Inc.
Collaborating Sponsors:
CTI Clinical Trial and Consulting Services
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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, Sod...
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 de...
Eligibility Criteria
Inclusion
- The subject must have:
- 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 and ODI score of 30 to 90.
Exclusion
- The subject is excluded if he/she has:
- 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.
- Clinical suspicion of facet pain as primary pain generator.
- 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.
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03347708
Start Date
February 26 2018
End Date
November 10 2022
Last Update
January 25 2023
Active Locations (14)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
University of Southern California
Los Angeles, California, United States, 90033
3
UC San Diego CIRM Alpha Stem Cell Clinic
San Diego, California, United States, 92037
4
Source Healthcare
Santa Monica, California, United States, 90403