110
Participants
Start Date
October 4, 2024
Primary Completion Date
October 31, 2025
Study Completion Date
April 30, 2026
VIA Disc NP
Participants will receive a single dose, intradiscal injection of 100 mg of VIA Disc NP mixed with sterile saline according to product Instructions for Use (IFU) and administered to the affected level(s), L1-S1 (1 or 2 levels).
Sham Injection
"Participants will receive the sham procedure at 1 or 2 levels.~The procedure will be identical to the investigational procedure with the following exception: A 20G spinal needle will be carefully inserted through the skin and muscle of the back but WILL NOT penetrate the annulus fibrosus of the intervertebral disc."
RECRUITING
Sydney Pain Research Centre, Wahroonga
RECRUITING
Australian Medical Research, Hurstville
RECRUITING
Genesis Research Services Pty Ltd, Broadmeadow
RECRUITING
Monash Clinical Research Pty Ltd, Clayton
RECRUITING
Cercare Clinical Research, Wayville
VIVEX Biologics, Inc.
INDUSTRY