ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
NCT ID: NCT06615505
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2024-10-04
2026-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
The participant has not experienced at least a 30% reduction in pain severity as determined by their 12-week VAS score
Sham participants who crossover into the VIA Disc NP group will receive an injection of VIA Disc NP and continue in the study.
OTHER
DOUBLE
Participants: when randomized into the trial, the patient will consent to be blinded to the type of treatment they will receive
Outcome assessors:
* Clinicians (sub-Is) completing the physical or neurological examination
* Study coordinator administering patient-reported outcomes and collecting other participant data
Study Groups
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VIA Disc NP
VIA 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).
Sham Arm
Sham 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.
Interventions
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VIA 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).
Sham 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.
Eligibility Criteria
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Inclusion Criteria
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
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)
22 Years
85 Years
ALL
No
Sponsors
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VIVEX Biologics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VIA-2024-001
Identifier Type: -
Identifier Source: org_study_id
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