Last updated on July 2019

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


Brief description of study

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 Study Description

This is a Phase I, firstinhuman, randomized, doubleblind, vehicle and placebo-controlled, parallelgroup, multi-center study in subjects with singlelevel, 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).

Clinical Study Identifier: NCT03347708

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Spine Institute of Louisiana

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