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