Evaluating a new 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

This study is testing a new tissue supplement to see if it can help people with chronic low-back pain caused by degenerated discs when other treatments haven't worked.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 22 Years to 85 Years
• Sex: All
• Sponsor: VIVEX Biologics, Inc. (Industry-sponsored)
• Locations: 5 sites (Broadmeadow, New South Wales and 4 other locations)
• Trial ID: NCT06615505 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of VIA Disc NP, a minimally processed human tissue allograft, for patients suffering from symptomatic lumbar intervertebral disc degeneration. It is a randomized, double-blind, sham-controlled, multi-center study involving participants who have experienced chronic low-back pain for over six months and have not responded to conservative treatments. Participants will receive either an intradiscal injection of VIA Disc NP or a sham procedure, allowing for a direct comparison of outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 85 with chronic low-back pain due to early to moderate degenerative disc disease unresponsive to conservative therapy.

Not a fit: Patients with symptomatic involvement of more than two lumbar discs or contraindications to MRI or sedation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief and improved function for patients with degenerative disc disease.

How similar studies have performed: While this approach is innovative, similar studies evaluating tissue allografts for disc degeneration have shown promising results, suggesting potential for success.

Eligibility criteria

Key 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)

Where this trial is running

Broadmeadow, New South Wales and 4 other locations

• Genesis Research Services Pty Ltd — Broadmeadow, New South Wales, Australia (Recruiting)
• Australian Medical Research — Hurstville, New South Wales, Australia (Recruiting)
• Sydney Pain Research Centre — Wahroonga, New South Wales, Australia (Recruiting)
• Cercare Clinical Research — Wayville, South Australia, Australia (Recruiting)
• Monash Clinical Research Pty Ltd — Clayton, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Stuart Pratt

Conditions Degenerative Disc Disease; Disc Degeneration; Lumbar Discogenic Pain