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

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955315
• Other study ID #: DGX-J01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 23, 2019
• Est. completion date: November 28, 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 one sham control 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/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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 28, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Biological:
• IDCT
Discogenic Cells + Sodium Hyaluronate Vehicle

Procedure:
• Sham
Needle puncture under the muscular layer in front of the intervertebral disc

Locations

Country	Name	City	State
Japan	University of Yamanashi Hospital	Chuo	Yamanashi Prefecture
Japan	Chiba University Hospital	Chuo-ku	Chiba Prefecture
Japan	Tokai University Hospital	Isehara	Kanagawa Prefecture
Japan	Nagoya university hospital	Showa-ku	Nagoya
Japan	Osaka University Hospital	Suita	Osaka
Japan	Mie University Hospital	Tsu city	Mie

Sponsors (1)

Lead Sponsor	Collaborator
DiscGenics, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiographic Assessments	To evaluate morphologic changes of treated intervertebral discs using MRI & X-Ray assessments.	1 year
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 AEs and SAEs observed from Day 1 to week 52	1 year
Primary	Efficacy (Pain): Visual Analogue Scale (VAS)	Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS). 0: no pain, 100: worst pain imaginable	6 months
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	1 year
Secondary	Efficacy (Pain): JOABPEQ	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.	1 year