NCT03709901

Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain

Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain With or Without Intervertebral Disc Herniation - VAST Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: VIVEX Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the safety and efficacy of viable allograft transplantation for the treatment of patients with symptomatic disc degeneration and tissue loss. All subjects randomized to Active Allograft will undergo injection of a viable allograft into the nucleus pulposus of the degenerated disc. All subjects randomized to Placebo will undergo injection with saline into the nucleus pulposus of the degenerated disc. All subjects randomized to Conservative Care will continue standard of care, with the opportunity to crossover at 3 months into the Active Allograft arm.

Detailed description

This is a multicenter, prospective, parallel arm study to assess patients who participated in the VAST trial and receiving either viable allograft, saline, or allograft after cross-over. These patients will be evaluated at baseline, injection, 6 months, and 12 months. Subjects will then have an option for a 24 months and 36 months extension after their index procedures. Patients who received saline or active allograft in the VAST study will be allowed to receive viable allograft and followed for an additional 12 and 24 months after that election. These subjects will need to meet initial inclusion/exclusion criteria again before another injection.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
OTHER	Active Allograft	Injection of viable allograft into the nucleus pulposus of the degenerated disc
OTHER	Placebo	Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc

Timeline

• Start date: 2017-08-22
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2018-10-17
• Last updated: 2021-07-07

Locations

13 sites across 1 country: United States