Summary

for people ages 18-75 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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.

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

Details

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).

Keywords

Degenerative Disc Disease Lumbar disc degeneration Low back pain Intervertebral disc degeneration Pharmaceutical Solutions Hyaluronic Acid IDCT Saline Solution Sodium Hyaluronate Saline Sodium Hyaluronate Vehicle

Eligibility

You can join if…

Open to people ages 18-75

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.

You CAN'T join if...

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.

Locations

  • UC San Diego CIRM Alpha Stem Cell Clinic accepting new patients
    San Diego California 92037 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
DiscGenics, Inc.
Links
http://www.discgenics.com/
ID
NCT03347708
Phase
Phase 1/2
Study Type
Interventional
Last Updated