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

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Biological: IDCT; Procedure: Sham

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chiba Prefecture
    • Chuo-ku, Chiba Prefecture, Japan, 260-8670
      • Chiba University Hospital
  • Kanagawa Prefecture
    • Isehara, Kanagawa Prefecture, Japan, 259-1193
      • Tokai University Hospital
  • Mie
    • Tsu city, Mie, Japan, 514-8507
      • Mie University Hospital
  • Nagoya
    • Showa-ku, Nagoya, Japan, 466-8550
      • Nagoya University Hospital
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Yamanashi Prefecture
    • Chuo, Yamanashi Prefecture, Japan, 409-3898
      • University of Yamanashi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose IDCT; Single intradiscal injection with Low Dose IDCT (3M cells).	Biological: IDCT; Discogenic Cells + Sodium Hyaluronate Vehicle; Other Names: Injectable Disc Cell Therapy
Experimental: High Dose IDCT; Single intradiscal injection with High Dose IDCT (9M cells)	Biological: IDCT; Discogenic Cells + Sodium Hyaluronate Vehicle; Other Names: Injectable Disc Cell Therapy
Sham Comparator: Sham; Sham needle puncture (outside disc)	Procedure: Sham; Needle puncture under the muscular layer in front of the intervertebral disc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Assessments	To evaluate morphologic changes of treated intervertebral discs using MRI & X-Ray assessments.	1 year

Collaborators and Investigators

• Sponsor: DiscGenics, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): November 28, 2022

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: DGX-J01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No