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RECRUITINGPHASE2

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

NCT06615505•VIVEX Biologics, Inc.

View on ClinicalTrials.gov

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

Age

22 - 85 years

Sex

ALL

Healthy Volunteers

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

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
+1 more criteria

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

Key Dates

Start Date

October 4, 2024

Primary Completion Date

October 1, 2025

Completion Date

April 1, 2026

Last Updated

February 14, 2025

Enrollment

110

ESTIMATED participants

Conditions

Degenerative Disc DiseaseDisc DegenerationLumbar Discogenic Pain

Interventions

VIA Disc NP

OTHER

Sham Injection

OTHER

Contacts

Stuart Pratt

CONTACT

901-238-5834 spratt@vivex.com

Nicolette Vega

CONTACT

650-888-1242 nicolette.vega@moxieclinical.com

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

NCT07254806

Degenerative Disc Disease

View study

RECRUITINGNA

Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults

NCT07044206

Disc Degeneration

View study

RECRUITINGNA

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs