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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03955315
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
DiscGenics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Biological: IDCT Procedure: Sham Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High Dose IDCT
Single intradiscal injection with High Dose IDCT (9M cells)
 Biological: IDCT
Discogenic Cells + Sodium Hyaluronate Vehicle
Other Name: Injectable Disc Cell Therapy
Experimental: Low Dose IDCT
Single intradiscal injection with Low Dose IDCT (3M cells).
 Biological: IDCT
Discogenic Cells + Sodium Hyaluronate Vehicle
Other Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Safety as measured by number of Adverse Events [ Time Frame: 1 year ]
    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

  2. Efficacy (Pain): Visual Analogue Scale (VAS) [ Time Frame: 6 months ]
    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 :
  1. Disability [ Time Frame: 1 year ]
    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

  2. Efficacy (Pain): JOABPEQ [ Time Frame: 1 year ]
    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.


Other Outcome Measures:
  1. Radiographic Assessments [ Time Frame: 1 year ]
    To evaluate morphologic changes of treated intervertebral discs using MRI & X-Ray assessments.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955315


Contacts
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Contact: Katie Simpson 8016644176 katie@discgenics.com

Locations
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Japan
Chiba University Hospital Not yet recruiting
Chuo-ku, Chiba Prefecture, Japan, 260-8670
Contact: Seiji Ohtori, M.D.,Ph.D.         
Tokai University Hospital Recruiting
Isehara, Kanagawa Prefecture, Japan, 259-1193
Contact: Daisuke Sakai, M.D, Ph.D.    +81‐463-93-1121    daisakai@is.icc.u-tokai.ac.jp   
Mie University Hospital Recruiting
Tsu city, Mie, Japan, 514-8507
Contact: Koji Akeda,, M.D.,Ph.D.    +81‐59-232-1111    k_akeda@clin.medic.mie-u.ac.jp   
Nagoya university hospital Recruiting
Showa-ku, Nagoya, Japan, 466-8550
Contact: Shiro Imagama, M.D, Ph.D    +81-52-741-2111    imagama@med.nagoya-u.ac.jp   
Osaka University Hospital Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Takashi Kaito, M.D, Ph.D    +81-6-6879-5111    takashikaito@ort.med.osaka-u.ac.jp   
University of Yamanashi Hospital Recruiting
Chuo, Yamanashi Prefecture, Japan, 409-3898
Contact: Hirotaka Haro, M.D., Ph.D    +81-55-273-1111    haro@yamanashi.ac.jp   
Sponsors and Collaborators
DiscGenics, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: DiscGenics, Inc.
ClinicalTrials.gov Identifier: NCT03955315    
Other Study ID Numbers: DGX-J01
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases