Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration
NCT ID: NCT03347708
Last Updated: 2023-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2018-02-26
2022-11-10
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High Dose IDCT
Single intradiscal injection with High Dose IDCT (9M cells).
IDCT
Discogenic Cells + Sodium Hyaluronate Vehicle
Low Dose IDCT
Single intradiscal injection with Low Dose IDCT (3M cells).
IDCT
Discogenic Cells + Sodium Hyaluronate Vehicle
Saline
Single intradiscal injection with saline solution.
Saline Solution
Sodium Chloride Solution
Sodium Hyaluronate Vehicle
Single intradiscal injection with Sodium Hyaluronate Vehicle.
Sodium Hyaluronate
Sodium Hyaluronate Vehicle
Interventions
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IDCT
Discogenic Cells + Sodium Hyaluronate Vehicle
Saline Solution
Sodium Chloride Solution
Sodium Hyaluronate
Sodium Hyaluronate Vehicle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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CTI Clinical Trial and Consulting Services
OTHER
DiscGenics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
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
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Semmes Murphey
Memphis, Tennessee, United States
Physicians' Research Options, LLC
Draper, Utah, United States
Virginia iSpine
Richmond, Virginia, United States
Countries
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References
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Gornet MF, Beall DP, Davis TT, Coric D, LaBagnara M, Krull A, DePalma MJ, Hsieh PC, Mallempati S, Schranck FW, Kelly C, Foley KT. Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration-Results of an FDA-Approved Biologic Therapy Randomized Clinical Trial. Int J Spine Surg. 2024 Jul 4;18(3):237-248. doi: 10.14444/8609.
Silverman LI, Dulatova G, Tandeski T, Erickson IE, Lundell B, Toplon D, Wolff T, Howard A, Chintalacharuvu S, Foley KT. In vitro and in vivo evaluation of discogenic cells, an investigational cell therapy for disc degeneration. Spine J. 2020 Jan;20(1):138-149. doi: 10.1016/j.spinee.2019.08.006. Epub 2019 Aug 20.
Related Links
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Related Info
Other Identifiers
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DGX-A01
Identifier Type: -
Identifier Source: org_study_id
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