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



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 75
Updated:2/27/2019
Start Date:February 26, 2018
End Date:April 2021
Contact:Katie Simpson
Email:katie@discgenics.com
Phone:8016644176

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A Prospective, Randomized, Double‑Blinded, Vehicle‑ and Placebo-Controlled, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of IDCT in Subjects With Single‑Level, Symptomatic Lumbar Intervertebral Disc Degeneration

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).

7 study visits will be completed by all subjects; screening, day 1 (injection day), week 4,
week 12, week 26, 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).

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. Patient who are deemed unsuitable for clinical study participation by the
investigator.
We found this trial at
13
sites
Shreveport, Louisiana 71101
Phone: 318-629-6339
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Los Angeles, California 90033
213) 740-2311
Phone: 323-442-7544
University of Southern California The University of Southern California is one of the world’s leading...
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Birmingham, Alabama 35235
Phone: 205-833-2228
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Charleston, South Carolina 29406
Phone: 843-789-3707
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Charlotte, North Carolina 28204
Phone: 704-831-4040
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Chesterfield, Missouri 63017
Phone: 314-738-4816
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Draper, Utah 84020
Phone: 801-352-9228
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Edgewood, Kentucky 41017
Phone: 859-757-1359
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Edgewood, KY
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Edmond, Oklahoma 73013
Phone: 405-601-2325
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Edmond, OK
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Memphis, Tennessee 38120
Phone: 901-259-5316
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Richmond, Virginia 23235
Phone: 804-330-2611
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Richmond, VA
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San Diego, California 92037
Phone: 844-317-7836
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San Diego, CA
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Santa Monica, California 90403
Phone: 310-574-2777
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Santa Monica, CA
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