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ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Sponsor: VIVEX Biologics, Inc.
Summary
VIA Disc NP is an off-the-shelf minimally processed human nucleus pulposus tissue allograft intended to supplement degenerated intervertebral discs. The study is a randomized, double-blind, sham-controlled, multi-center study in participants with symptomatic lumbar intervertebral disc degeneration (\> 6 months) and unresponsive to conservative therapy for at least 3 months. Participants will be randomized on a 1:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or a sham procedure at 1 or 2 levels.
Official title: ASCEND: A Randomized, Double Blind, Sham-Controlled, Multi-Center Phase I/II Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Key Details
Gender
All
Age Range
22 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2024-10-04
Completion Date
2026-04
Last Updated
2025-02-14
Healthy Volunteers
No
Interventions
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.
Locations (5)
Genesis Research Services Pty Ltd
Broadmeadow, New South Wales, Australia
Australian Medical Research
Hurstville, New South Wales, Australia
Sydney Pain Research Centre
Wahroonga, New South Wales, Australia
Cercare Clinical Research
Wayville, South Australia, Australia
Monash Clinical Research Pty Ltd
Clayton, Victoria, Australia