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

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Biological: IDCT; Drug: Saline Solution; Drug: Sodium Hyaluronate

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: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • San Diego, California, United States, 92037
      • UC San Diego CIRM Alpha Stem Cell Clinic
    • Santa Monica, California, United States, 90403
      • Source Healthcare
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Otrimed
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Orthopedic Center of St. Louis
  • New York
    • New York, New York, United States, 10022
      • Ainsworth Institute Of Pain Management
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina Neurosurgery & Spine Associates
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Clinical Investigations, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Semmes Murphey
  • Utah
    • Draper, Utah, United States, 84020
      • Physicians' Research Options, LLC
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Virginia iSpine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Dose IDCT; Single intradiscal injection with High Dose IDCT (9M cells).	Biological: IDCT; Discogenic Cells + Sodium Hyaluronate Vehicle; Other Names: 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 Names: Progenitor Cells, Stem Cells, Allogeneic Cell Therapy
Placebo Comparator: Saline; Single intradiscal injection with saline solution.	Drug: Saline Solution; Sodium Chloride Solution; Other Names: Saline injection, Placebo control
Placebo Comparator: Sodium Hyaluronate Vehicle; Single intradiscal injection with Sodium Hyaluronate Vehicle.	Drug: Sodium Hyaluronate; Sodium Hyaluronate Vehicle; Other Names: Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 grade 2 or greater AEs and SAEs observed from Day 1 to week 104	2 Years
Efficacy (Pain)	Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS). 0: no pain, 100: worst pain imaginable.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability	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 Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory	Imaging parameters will be evaluated via radiological evaluations	2 Years

Collaborators and Investigators

• Sponsor: DiscGenics, Inc.
• Collaborators: CTI Clinical Trial and Consulting Services

Publications and helpful links

General 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. 2020 Jan;20(1):138-149. doi: 10.1016/j.spinee.2019.08.006. Epub 2019 Aug 20.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2018
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Low back pain; Lumbar disc degeneration; Intervertebral disc degeneration
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Pharmaceutical Solutions; Hyaluronic Acid
• Other Study ID Numbers: DGX-A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No