NCT03955315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2019

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

May 23, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2022

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2022

Enrollment Period

2.7 years

First QC Date

May 14, 2019

Last Update Submit

November 17, 2025

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Disability

    1 year

  • Efficacy (Pain): JOABPEQ

    1 year

Other Outcomes (1)

  • Radiographic Assessments

    1 year

Study Arms (3)

High Dose IDCT

EXPERIMENTAL

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

Biological: IDCT

Low Dose IDCT

EXPERIMENTAL

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

Biological: IDCT

Sham

SHAM COMPARATOR

Sham needle puncture (outside disc)

Procedure: Sham

Interventions

IDCTBIOLOGICAL

Discogenic Cells + Sodium Hyaluronate Vehicle

Also known as: Injectable Disc Cell Therapy
High Dose IDCTLow Dose IDCT
ShamPROCEDURE

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

Sham

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chiba University Hospital

Chuo-ku, Chiba, 260-8670, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

Nagoya university hospital

Shōwaku, Nagoya, 466-8550, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

University of Yamanashi Hospital

Chūō, Yamanashi, 409-3898, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31442616DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 20, 2019

Study Start

May 23, 2019

Primary Completion

February 1, 2022

Study Completion

November 28, 2022

Last Updated

November 20, 2025

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

JP(6)