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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347708
• Other study ID #: DGX-A01
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2018
• Est. completion date: November 10, 2022

Study information

• Verified date: November 2022
• Source: DiscGenics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 10, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Biological:
• IDCT
Discogenic Cells + Sodium Hyaluronate Vehicle

Drug:
• Saline Solution
Sodium Chloride Solution
• Sodium Hyaluronate
Sodium Hyaluronate Vehicle

Locations

Country	Name	City	State
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Carolina Neurosurgery & Spine Associates	Charlotte	North Carolina
United States	Orthopedic Center of St. Louis	Chesterfield	Missouri
United States	Physicians' Research Options, LLC	Draper	Utah
United States	Otrimed	Edgewood	Kentucky
United States	Clinical Investigations, LLC	Edmond	Oklahoma
United States	University of Southern California	Los Angeles	California
United States	Semmes Murphey	Memphis	Tennessee
United States	Ainsworth Institute of Pain Management	New York	New York
United States	Virginia iSpine	Richmond	Virginia
United States	UC San Diego CIRM Alpha Stem Cell Clinic	San Diego	California
United States	Source Healthcare	Santa Monica	California
United States	Spine Institute of Louisiana	Shreveport	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
DiscGenics, Inc.	CTI Clinical Trial and Consulting Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory	Imaging parameters will be evaluated via radiological evaluations	2 Years
Primary	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	2 Years
Primary	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.	1 Year
Secondary	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	2 Years

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