Clinical Research Directory

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. Participants who consent to participate in the study and meet all eligibility criteria during the Screening/Baseline period will return on Day 1 to be randomized to either the VIA Disc NP or sham-control group. At 12-weeks post-treatment, participants allocated to the sham-control group will be given the option to crossover to the VIA Disc NP group if they meet the requirement to crossover. All participants will be followed through 52-weeks post-treatment at which time they will be asked if they would like to consent to participate in an extended long-term follow-up period. The sham-control group participants who did not crossover at 12-weeks will be exited from the study at this visit. If participants consent to participate in the extended long-term follow-up period, the VIA Disc NP group will be followed through 24-Months and the sham-control group will be followed through 27-months. If the participant declines participation, they will be exited from the study at this visit.

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

Conditions

Interventions

Locations (5)