ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement fo… (NCT06615505) | Clinical Trial Compass
RecruitingPhase 2
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Australia110 participantsStarted 2024-10-04
Plain-language 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.
Who can participate
Age range22 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 22 to 85 years old
✓. Diagnosis of early to moderate DDD, 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 as confirmed with the Neurologic Exam indicating positive provocation with sustained hip flexion at the time of screening
✓. 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
✓. Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS at the time of Screening
✓. ODI score of ≥ 40 to ≤ 80 at the time of Screening
Exclusion criteria
✕. Contraindication to MRI for any reason
✕. Contraindications to the proposed sedation/anesthetic protocol
What they're measuring
1
Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from Baseline to 26 weeks.
Timeframe: Baseline to 26 Weeks
2
Primary Safety Endpoint - Proportion of participants reporting Treatment-related AEs at 12 weeks
✕. Symptomatic involvement of more than two lumbar discs
✕. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc(s)
✕. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc
✕. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology
✕. Clinical suspicion of facet pain as primary pain generator
✕. Women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study. Pregnancy is confirmed by: