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NCT Number: NCT03347708

Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for 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.

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Key information

Conditions

Degenerative Disc Disease Back Pain Bone Diseases Intervertebral Disc Degeneration Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The subject must have:

  • 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 and ODI score of 30 to 90.

Exclusion criteria

The subject is excluded if he/she has:

  • 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.
  • Clinical suspicion of facet pain as primary pain generator.
  • 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.

Treatment and study plan

IDCT

Biological

Discogenic Cells + Sodium Hyaluronate Vehicle

Other names: Progenitor Cells, Stem Cells, Allogeneic Cell Therapy

Saline Solution

Drug

Sodium Chloride Solution

Other names: Saline injection, Placebo control

Sodium Hyaluronate

Drug

Sodium Hyaluronate Vehicle

Other names: Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle control

Primary outcomes

  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 outcomes

  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 outcomes

  1. Exploratory

    Time frame: 2 Years

    Imaging parameters will be evaluated via radiological evaluations

Sponsors and collaborators

Lead sponsor

DiscGenics, Inc.

Industry

Collaborators

  • CTI Clinical Trial and Consulting Services

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 20, 2017
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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