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

Phase 2

Recruiting

• Conditions: Degenerative Disc Disease; Disc Degeneration; Lumbar Discogenic Pain
• Interventions: Other: VIA Disc NP; Other: Sham Injection

• Registration Number: NCT06615505
• Lead Sponsor: VIVEX Biologics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-26
• Study Start: 2024-10-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-10
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Age 22 to 85 years old
2. Diagnosis of early to moderate DDD, Modified Pfirrmann Grade 3-7
3. Chronic axial midline low-back pain with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
4. Positive hip flexion test as confirmed with the Neurologic Exam indicating positive provocation with sustained hip flexion at the time of screening
5. Demonstrated intolerance to sitting for more than 30 minutes at a time based on self-report or assessed by a qualified healthcare professional at the screening visit
6. Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS at the time of Screening
7. ODI score of ≥ 40 to ≤ 80 at the time of Screening

Key

Exclusion Criteria

1. Contraindication to MRI for any reason

2. Contraindications to the proposed sedation/anesthetic protocol

3. Symptomatic involvement of more than two lumbar discs

4. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc(s)

5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc

6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology

7. Clinical suspicion of facet pain as primary pain generator

8. Women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study. Pregnancy is confirmed by:

   • A positive pregnancy test during the screening visit
   • Self-reported pregnancy

9. Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VIA Disc NP	VIA Disc NP	-
Sham Arm	Sham Injection	-

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from Baseline to 26 weeks.	Baseline to 26 Weeks	A comparison of the proportion of participants who show a minimally clinically important difference (MCID), defined as at least a 30% reduction in back pain VAS score from baseline to 26 weeks (6 months), in the VIA Disc NP group to that in the sham-control group.
Primary Safety Endpoint - Proportion of participants reporting Treatment-related AEs at 12 weeks	Baseline to 12 weeks	The proportion of participants that experience one or more treatment-related (including procedure) adverse events in the VIA Disc NP group compared to the sham-control group at 12 weeks (3 months) as determined by the Principal Investigator.

Trial Locations

Locations (5)

Genesis Research Services Pty Ltd; 🇦🇺 Broadmeadow, New South Wales, Australia

Australian Medical Research; 🇦🇺 Hurstville, New South Wales, Australia

Sydney Pain Research Centre; 🇦🇺 Wahroonga, New South Wales, Australia

Cercare Clinical Research; 🇦🇺 Wayville, South Australia, Australia

Monash Clinical Research Pty Ltd; 🇦🇺 Clayton, Victoria, Australia