RecruitingPhase 2NCT06615505

ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs

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

Sponsor

VIVEX Biologics, Inc.

Enrollment

110 participants

Start Date

Oct 4, 2024

Study Type

INTERVENTIONAL

Conditions

Degenerative Disc Disease Disc Degeneration Lumbar Discogenic Pain

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.

Eligibility

Min Age: 22 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment called VIA Disc NP, which is injected into damaged spinal discs to reduce chronic lower back pain caused by degenerative disc disease (DDD) — when the cushioning discs between your vertebrae break down over time. The treatment aims to restore disc function and relieve pain without surgery. **You may be eligible if...** - You are between 22 and 85 years old - You have been diagnosed with early to moderate degenerative disc disease - You have had chronic lower back pain (in the center of your back) for at least 6 months - Your pain has not improved after at least 3 months of conservative care (physical therapy, medications, injections) **You may NOT be eligible if...** - Your back pain radiates down your leg (radicular pain) - You have severe disc degeneration or spinal instability - You have had prior spinal surgery at the affected level - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERVIA Disc NP

Participants will receive a single dose, intradiscal injection of 100 mg of VIA Disc NP mixed with sterile saline according to product Instructions for Use (IFU) and administered to the affected level(s), L1-S1 (1 or 2 levels).

OTHERSham Injection

Participants will receive the sham procedure at 1 or 2 levels. The procedure will be identical to the investigational procedure with the following exception: 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.