Clinical trial NCT03347708: Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Degenerative Disc Disease
Keywords: Lumbar disc degeneration
Low back pain
Intervertebral disc degeneration
Lead sponsor: DiscGenics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: CTI Clinical Trial and Consulting Services
First posted: 2017-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, Sodium Hyaluronate vehicle) in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.

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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Safety as measured by number of Adverse Events
timeFrame: 2 Years
measure: Efficacy (Pain)
timeFrame: 1 Year
Secondary outcomes:
measure: Disability
timeFrame: 2 Years
Other outcomes:
measure: Exploratory
timeFrame: 2 Years
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Diego
country: United States
facility: UC San Diego CIRM Alpha Stem Cell Clinic
state: California
city: Santa Monica
country: United States
facility: Source Healthcare
state: California
city: Edgewood
country: United States
facility: Otrimed
state: Kentucky
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Chesterfield
country: United States
facility: Orthopedic Center of St. Louis
state: Missouri
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery & Spine Associates
state: North Carolina
city: Edmond
country: United States
facility: Clinical Investigations, LLC
state: Oklahoma
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Semmes Murphey
state: Tennessee
city: Draper
country: United States
facility: Physicians' Research Options, LLC
state: Utah
city: Richmond
country: United States
facility: Virginia iSpine
state: Virginia
Study officials:
References:
citation: 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.