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Trial record 2 of 2 for:    discgenics

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

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ClinicalTrials.gov Identifier: NCT03347708
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
DiscGenics, Inc.

Tracking Information
First Submitted Date  ICMJE November 1, 2017
First Posted Date  ICMJE November 20, 2017
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE February 26, 2018
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
  • Safety as measured by number of Adverse Events [ Time Frame: 2 Years ]
    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 grade 2 or greater AEs and SAEs observed from Day 1 to week 104
  • Efficacy (Pain) [ Time Frame: 1 Year ]
    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
 (submitted: November 15, 2017)
  • Safety as measured by number of Adverse Events [ Time Frame: 2 Years ]
    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 grade 2 or greater AEs and SAEs observed from Day 1 to week 104
  • Efficacy (Pain) [ Time Frame: 1 Year ]
    Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS).
Change History Complete list of historical versions of study NCT03347708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
Disability [ Time Frame: 2 Years ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
Disability [ Time Frame: 2 Years ]
Evaluate the effect of IDCT on disability as measured by the Oswestry Disability Index (ODI).
Current Other Pre-specified Outcome Measures
 (submitted: November 15, 2017)
Exploratory [ Time Frame: 2 Years ]
Imaging parameters will be evaluated via radiological evaluations
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 Intervertebral Disc Degeneration
Official Title  ICMJE A Prospective, Randomized, Double‑Blinded, Vehicle‑ and Placebo-Controlled, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of IDCT in Subjects With Single‑Level, Symptomatic Lumbar Intervertebral Disc Degeneration
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 two controls (saline, Sodium Hyaluronate vehicle) 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, first‑in‑human, randomized, double‑blind, vehicle and placebo-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 two control groups (saline, Sodium Hyaluronate).

8 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26, week 52, week 72 and week 104. The subject will be assessed for safety and efficacy utilizing VAS and ODI questionnaires alongside radiographic evaluations. The study will have a 1 year follow-up and a 1 year extension period (total 2 years).

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)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE Degenerative Disc Disease
Intervention  ICMJE
  • Biological: IDCT
    Discogenic Cells + Sodium Hyaluronate Vehicle
    Other Name: Progenitor Cells, Stem Cells, Allogeneic Cell Therapy
  • Drug: Saline Solution
    Sodium Chloride Solution
    Other Name: Saline injection, Placebo control
  • Drug: Sodium Hyaluronate
    Sodium Hyaluronate Vehicle
    Other Name: Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle control
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
  • Placebo Comparator: Saline
    Single intradiscal injection with saline solution.
    Intervention: Drug: Saline Solution
  • Placebo Comparator: Sodium Hyaluronate Vehicle
    Single intradiscal injection with Sodium Hyaluronate Vehicle.
    Intervention: Drug: Sodium Hyaluronate
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: November 15, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: The subject must have:

  1. Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7.
  2. Chronic low‑back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care.
  3. Low‑back pain of 40 to 90 mm on the VAS and ODI score of 30 to 90.

Exclusion Criteria: The subject is excluded if he/she has:

  1. Symptomatic involvement of more than one lumbar disc.
  2. Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.
  3. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc.
  4. Evidence of dynamic instability on lumbar flexion‑extension radiographs.
  5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc.
  6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology.
  7. Clinical suspicion of facet pain as primary pain generator.
  8. Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection.
  9. 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03347708
Other Study ID Numbers  ICMJE DGX-A01
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 Not Provided
Responsible Party DiscGenics, Inc.
Study Sponsor  ICMJE DiscGenics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DiscGenics, Inc.
Verification Date September 2019

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