NCT06778447

Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease

Randomized, Sham-Controlled, Multi-Center, Double-Blind Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft to Supplement Nucleus Pulposus Tissue in Participants With Lumbar Discogenic Pain Associated With Degenerative Disc Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 496 (estimated)
• Sponsor: VIVEX Biologics, Inc. · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs. This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.

Conditions

• Degenerative Disc Disease
• Disc Degeneration
• Lumbar Discogenic Pain

Interventions

Type	Name	Description
OTHER	VIA Disc NP	VIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.
OTHER	Sham	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. No saline or VIA Disc NP will be injected.

Timeline

• Start date: 2025-02-17
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2025-01-16
• Last updated: 2026-02-27

Locations

20 sites across 1 country: United States