NCT05412277

VIA Disc Nucleus Pulposus Older Patients Pilot

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: VIVEX Biologics, Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.

Detailed description

The study will include adult subjects, ages 65 years and older, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care. Each subject will receive one injection per each affected level (max of 3 levels) and be evaluated for efficacy and safety during the 6 month observation period. The study is expected to be completed within 18 months, inclusive of enrollment and follow-up for all subjects. Subjects will be evaluated at baseline and followed through 6 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 26 weeks

Conditions

• Degenerative Disc Disease
• Low Back Pain
• Disc Degeneration

Interventions

Type	Name	Description
OTHER	VIA Disc Nucleus Pulposus Allograft	A single dose, intradiscal injection of 100mg of VIA Disc NP mixed with 2ml sterile saline administered to the affected 1 to 3 levels, L1-S1.

Timeline

• Start date: 2022-10-17
• Primary completion: 2024-08-30
• Completion: 2024-12-31
• First posted: 2022-06-09
• Last updated: 2024-04-29

Locations

5 sites across 1 country: United States