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

Phase 1

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Biological: IDCT; Procedure: Sham

• Registration Number: NCT03955315
• Lead Sponsor: DiscGenics, Inc.

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).

Study Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-20
• Study Start: 2019-05-23
• Primary Completion: 2022-02-01
• Status Verified: 2022-11
• Study Completion: 2022-11-28
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose IDCT	IDCT	Single intradiscal injection with Low Dose IDCT (3M cells).
High Dose IDCT	IDCT	Single intradiscal injection with High Dose IDCT (9M cells)
Sham	Sham	Sham needle puncture (outside disc)

Primary Outcome Measures

Name	Time	Method
Efficacy (Pain): Visual Analogue Scale (VAS)	6 months	Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS). 0: no pain, 100: worst pain imaginable
Safety as measured by number of Adverse Events	1 year	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 AEs and SAEs observed from Day 1 to week 52

Secondary Outcome Measures

Name	Time	Method
Disability	1 year	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
Efficacy (Pain): JOABPEQ	1 year	Evaluate the effect of IDCT on pain as measured by JOABPEQ. The range of the score for each domain is from 0 to 100, with higher scores indicating a better condition.

Trial Locations

Locations (6)

Chiba University Hospital; 🇯🇵 Chuo-ku, Chiba Prefecture, Japan

Tokai University Hospital; 🇯🇵 Isehara, Kanagawa Prefecture, Japan

University of Yamanashi Hospital; 🇯🇵 Chuo, Yamanashi Prefecture, Japan

Mie University Hospital; 🇯🇵 Tsu city, Mie, Japan

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan

Nagoya university hospital; 🇯🇵 Showa-ku, Nagoya, Japan