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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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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.

Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 20, 2019
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE May 23, 2019
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03955315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 15, 2019)
Radiographic Assessments [ Time Frame: 1 year ]
To evaluate morphologic changes of treated intervertebral discs using MRI & X-Ray assessments.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Disc Degeneration
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Degenerative Disc Disease
Intervention  ICMJE
  • Biological: IDCT
    Discogenic Cells + Sodium Hyaluronate Vehicle
    Other Name: Injectable Disc Cell Therapy
  • Procedure: Sham
    Needle puncture under the muscular layer in front of the intervertebral disc
Study Arms  ICMJE
  • Experimental: High Dose IDCT
    Single intradiscal injection with High Dose IDCT (9M cells)
    Intervention: Biological: IDCT
  • Experimental: Low Dose IDCT
    Single intradiscal injection with Low Dose IDCT (3M cells).
    Intervention: Biological: IDCT
  • Sham Comparator: Sham
    Sham needle puncture (outside disc)
    Intervention: Procedure: Sham
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. 2019 Aug 20. pii: S1529-9430(19)30935-0. doi: 10.1016/j.spinee.2019.08.006. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katie Simpson 8016644176 katie@discgenics.com
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03955315
Other Study ID Numbers  ICMJE DGX-J01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party DiscGenics, Inc.
Study Sponsor  ICMJE DiscGenics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DiscGenics, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP