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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 : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
DiscGenics, Inc.

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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Biological: IDCT Drug: Saline Solution Drug: Sodium Hyaluronate Phase 1 Phase 2

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).

7 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26, 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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: Progenitor Cells, Stem Cells, Allogeneic Cell Therapy

Experimental: Low Dose IDCT
Single intradiscal injection with Low Dose IDCT (3M cells).
Biological: IDCT
Discogenic Cells + Sodium Hyaluronate Vehicle
Other Name: Progenitor Cells, Stem Cells, Allogeneic Cell Therapy

Placebo Comparator: Saline
Single intradiscal injection with saline solution.
Drug: Saline Solution
Sodium Chloride Solution
Other Name: Saline injection, Placebo control

Placebo Comparator: Sodium Hyaluronate Vehicle
Single intradiscal injection with Sodium Hyaluronate Vehicle.
Drug: Sodium Hyaluronate
Sodium Hyaluronate Vehicle
Other Name: Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle control




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Exploratory [ Time Frame: 2 Years ]
    Imaging parameters will be evaluated via radiological evaluations



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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: 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. Patient who are deemed unsuitable for clinical study participation by the investigator.

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): NCT03347708


Contacts
Contact: Katie Simpson 8016644176 katie@discgenics.com

Locations
United States, Alabama
Alabama Clinical Therapeutics, LLC Recruiting
Birmingham, Alabama, United States, 35235
Contact: Brittany Fry    205-833-2228    Brittany.Fry@actstudy.net   
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Anush Arakelyan    323-442-7544    Anush.Arakelyan@med.usc.edu   
UC San Diego CIRM Alpha Stem Cell Clinic Recruiting
San Diego, California, United States, 92037
Contact: Teresa Rzesiewicz    844-317-7836    alphastemcellclinic@ucsd.edu   
United States, Louisiana
Spine Institute of Louisiana Not yet recruiting
Shreveport, Louisiana, United States, 71101
Contact: Marcus Stone    318-629-6339    clinicalresearch@louisianaspine.org   
United States, Missouri
Orthopedic Center of St. Louis Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Chas Schranck    314-738-4816    cschranck@spirittresearch.com   
United States, North Carolina
Carolina Neurosurgery & Spine Associates Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Sue Lydon    704-831-4010    susan.lydon@cnsa.com   
United States, Tennessee
Semmes Murphey Recruiting
Memphis, Tennessee, United States, 38120
Contact: Amanda Nolte    901-259-5316    annolte@semmes-murphey.com   
United States, Virginia
Virginia iSpine Recruiting
Richmond, Virginia, United States, 23235
Contact: Janet Baker    804-330-2611      
Contact: Karen Wilson    8043302611      
Sponsors and Collaborators
DiscGenics, Inc.

Additional Information:
Responsible Party: DiscGenics, Inc.
ClinicalTrials.gov Identifier: NCT03347708     History of Changes
Other Study ID Numbers: DGX-A01
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DiscGenics, Inc.:
Lumbar disc degeneration
Low back pain
Intervertebral disc degeneration

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Pharmaceutical Solutions
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents