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

Launched by VIVEX BIOLOGICS, INC. · Sep 24, 2024

Keywords

ClinConnect Summary

The ASCEND clinical trial is studying a new treatment called VIA Disc NP, which is designed to help people suffering from chronic low back pain due to degenerative disc disease. This condition happens when the discs in your spine start to break down, causing pain that doesn't get better with typical treatments like physical therapy or medication. In this trial, participants will receive either an injection of VIA Disc NP into their damaged discs or a "sham" (placebo) injection that doesn't contain the treatment. This will help researchers determine how safe and effective VIA Disc NP is for relieving pain.

To be eligible for the study, participants should be between 22 and 85 years old, have experienced back pain for at least six months, and have not found relief from previous treatments. They should also have certain signs of disc degeneration confirmed by a healthcare professional. Participants will be randomly assigned to receive either the treatment or the sham procedure, and they will be monitored closely throughout the trial. This study is currently recruiting participants, and it’s important to note that pregnant or breastfeeding women, as well as those with certain medical conditions, will not be allowed to participate.

Gender

ALL

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)