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

Vivex Biomedical

Status and phase: Enrolling; Phase 2

Conditions: Degenerative Disc Disease; Lumbar Discogenic Pain; Disc Degeneration

Treatments: Other: VIA Disc NP; Other: Sham Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06615505

VIA-2024-001

Details and patient eligibility

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 22 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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110 participants in 2 patient groups

VIA Disc NP

Active Comparator group

Treatment:

Other: VIA Disc NP

Sham Arm

Sham Comparator group

Treatment:

Other: Sham Injection