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RECRUITING
NCT06615505
PHASE2

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

Sponsor: VIVEX Biologics, Inc.

View on ClinicalTrials.gov

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

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.

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