Clinical trial NCT03955315: Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Disc Degeneration
Official title: A Randomized, Double Blind, Sham-controlled, Multi-center Phase I / II Clinical Study to Assess the Safety and Efficacy of IDCT in Patients With Lumbar Degenerative Disc Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Degenerative Disc Disease
Lead sponsor: DiscGenics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-20
Enrollment: 38
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 one sham control 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/II, randomized, double-blind, sham-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 one sham control group.

6 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26 and week 52. The subject will be assessed for safety and efficacy utilizing VAS, ODI and JOABPEQ questionnaires alongside radiographic evaluations. The study will have a 6 month follow-up and a 6 month extension period (total 1 year).

Eligibility criteria: Inclusion Criteria:

* 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
* ODI score of 30 to 90.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Safety as measured by number of Adverse Events
timeFrame: 1 year
measure: Efficacy (Pain): Visual Analogue Scale (VAS)
timeFrame: 6 months
Secondary outcomes:
measure: Disability
timeFrame: 1 year
measure: Efficacy (Pain): JOABPEQ
timeFrame: 1 year
Other outcomes:
measure: Radiographic Assessments
timeFrame: 1 year
Locations:
city: Chuo-ku
country: Japan
facility: Chiba University Hospital
state: Chiba Prefecture
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa Prefecture
city: Tsu city
country: Japan
facility: Mie University Hospital
state: Mie
city: Showa-ku
country: Japan
facility: Nagoya university hospital
state: Nagoya
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Chuo
country: Japan
facility: University of Yamanashi Hospital
state: Yamanashi Prefecture
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.