NCT05201287

VIA Disc NP Pilot for Patients With Symptomatic Degenerated Discs

A Pilot Study Evaluating the Safety and Clinical Effectiveness of Nucleus Pulposus Allograft for Supplementation of Nucleus Pulposus Tissue in Patients With Symptomatic Degenerated Discs

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: VIVEX Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

VIA Disc NP is an allograft intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.

Detailed description

The study will include adult subjects, ages 18 years or older, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care. For the purpose of the primary analysis, subjects are considered enrolled in the study once they have signed the informed consent. Each subject will receive one injection per level (max of 2 levels) and be evaluated for efficacy and safety during the up to 24 month observation period. The study is expected to be completed within 26 months, inclusive of enrollment and follow-up for all subjects. Subjects will be evaluated at baseline and followed through up to 24 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 104 weeks.

Conditions

• Degenerative Disc Disease
• Low Back Pain
• Disc Degeneration

Interventions

Type	Name	Description
OTHER	VIA Disc NP	VIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.

Timeline

• Start date: 2021-12-30
• Primary completion: 2023-01-05
• Completion: 2024-12-27
• First posted: 2022-01-21
• Last updated: 2024-04-29

Locations

6 sites across 1 country: United States