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

NCT ID: NCT03955315

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-23
• Study Completion Date: 2022-11-28

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, 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).

Conditions

Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High Dose IDCT

Single intradiscal injection with High Dose IDCT (9M cells)

Group Type: EXPERIMENTAL

IDCT

Intervention Type: BIOLOGICAL

Discogenic Cells + Sodium Hyaluronate Vehicle

Low Dose IDCT

Single intradiscal injection with Low Dose IDCT (3M cells).

Group Type: EXPERIMENTAL

IDCT

Intervention Type: BIOLOGICAL

Discogenic Cells + Sodium Hyaluronate Vehicle

Sham

Sham needle puncture (outside disc)

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: PROCEDURE

Needle puncture under the muscular layer in front of the intervertebral disc

Interventions

IDCT

Discogenic Cells + Sodium Hyaluronate Vehicle

Intervention Type: BIOLOGICAL

Sham

Needle puncture under the muscular layer in front of the intervertebral disc

Intervention Type: PROCEDURE

Other Intervention Names

Injectable Disc Cell Therapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DiscGenics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chiba University Hospital

Chuo-ku, Chiba, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Mie University Hospital

Tsu, Mie-ken, Japan

Nagoya university hospital

Shōwaku, Nagoya, Japan

Osaka University Hospital

Suita, Osaka, Japan

University of Yamanashi Hospital

Chūō, Yamanashi, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 31442616 (View on PubMed)

Other Identifiers

DGX-J01

Identifier Type: -

Identifier Source: org_study_id