Actively Recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Led by VIVEX Biologics, Inc. · Updated on 2025-02-14
110
Participants Needed
5
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 to 85 years old
- Diagnosis of early to moderate degenerative disc disease, Modified Pfirrmann Grade 3-7
- 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
- Positive hip flexion test confirmed by neurologic exam at screening
- Intolerance to sitting for more than 30 minutes based on self-report or healthcare professional assessment
- Low-back pain severity score between 40 and 90 mm on the Visual Analog Scale at screening
- Oswestry Disability Index score between 40 and 80 at screening
You will not qualify if you...
- Contraindication to MRI for any reason
- Contraindications to sedation or anesthetic protocol
- Symptomatic involvement of more than two lumbar discs
- Spinal fracture, previous lumbar spine surgery, or previous treatment of the target disc(s)
- Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis, undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc
- Clinical suspicion of full thickness annular tear or other abnormal disc morphology at the target disc
- Clinical suspicion that facet pain is the primary pain source
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study
- Women of childbearing potential not using reliable contraception as determined by the Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Genesis Research Services Pty Ltd
Broadmeadow, New South Wales, Australia, 2292
Actively Recruiting
2
Australian Medical Research
Hurstville, New South Wales, Australia, 2220
Actively Recruiting
3
Sydney Pain Research Centre
Wahroonga, New South Wales, Australia, 2076
Actively Recruiting
4
Cercare Clinical Research
Wayville, South Australia, Australia, 5034
Actively Recruiting
5
Monash Clinical Research Pty Ltd
Clayton, Victoria, Australia, 3168
Actively Recruiting
Research Team
S
Stuart Pratt
CONTACT
N
Nicolette Vega
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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