NCT06615505

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: VIVEX Biologics, Inc. · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Disc Disease
• Disc Degeneration
• Lumbar Discogenic Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-04
• Primary completion: 2025-10-01
• Completion: 2026-04-01
• First posted: 2024-09-26
• Last updated: 2025-02-14

Locations

5 sites across 1 country: Australia