ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs

PHASE2RecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

October 4, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

April 30, 2026

Conditions
Degenerative Disc DiseaseDisc DegenerationLumbar Discogenic Pain
Interventions
OTHER

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).

OTHER

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."

Trial Locations (5)

2076

RECRUITING

Sydney Pain Research Centre, Wahroonga

2220

RECRUITING

Australian Medical Research, Hurstville

2292

RECRUITING

Genesis Research Services Pty Ltd, Broadmeadow

3168

RECRUITING

Monash Clinical Research Pty Ltd, Clayton

5034

RECRUITING

Cercare Clinical Research, Wayville

All Listed Sponsors
lead

VIVEX Biologics, Inc.

INDUSTRY