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

Primary Purpose

Degenerative Disc Disease

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

IDCT

Sham

About this trial

This is an interventional treatment trial for Degenerative Disc Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chiba University Hospital
Tokai University Hospital
Mie University Hospital
Nagoya university hospital
Osaka University Hospital
University of Yamanashi Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

High Dose IDCT

Low Dose IDCT

Sham

Arm Description

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

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

Sham needle puncture (outside disc)

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT03955315

First Posted

May 14, 2019

Last Updated

November 28, 2022

Sponsor

DiscGenics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03955315

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

May 23, 2019 (Actual)

Primary Completion Date

February 1, 2022 (Actual)

Study Completion Date

November 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DiscGenics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Disc Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Dose IDCT

Arm Type

Experimental

Arm Description

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

Arm Title

Low Dose IDCT

Arm Type

Experimental

Arm Description

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

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

Sham needle puncture (outside disc)

Intervention Type

Biological

Intervention Name(s)

IDCT

Other Intervention Name(s)

Injectable Disc Cell Therapy

Intervention Description

Discogenic Cells + Sodium Hyaluronate Vehicle

Intervention Type

Procedure

Intervention Name(s)

Sham

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety as measured by number of Adverse Events

Description

Time Frame

1 year

Title

Efficacy (Pain): Visual Analogue Scale (VAS)

Description

Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS). 0: no pain, 100: worst pain imaginable

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Disability

Description

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

Time Frame

1 year

Title

Efficacy (Pain): JOABPEQ

Description

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.

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Radiographic Assessments

Description

To evaluate morphologic changes of treated intervertebral discs using MRI & X-Ray assessments.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Chiba University Hospital

City

Chuo-ku

State/Province

Chiba Prefecture

ZIP/Postal Code

260-8670

Country

Japan

Facility Name

Tokai University Hospital

City

Isehara

State/Province

Kanagawa Prefecture

ZIP/Postal Code

259-1193

Country

Japan

Facility Name

Mie University Hospital

City

Tsu city

State/Province

Mie

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

Nagoya university hospital

City

Showa-ku

State/Province

Nagoya

ZIP/Postal Code

466-8550

Country

Japan

Facility Name

Osaka University Hospital

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

University of Yamanashi Hospital

City

Chuo

State/Province

Yamanashi Prefecture

ZIP/Postal Code

409-3898

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31442616

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.

Results Reference

derived

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

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