Clinical trial NCT06615505: ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Official title: ASCEND: A Randomized, Double Blind, Sham-Controlled, Multi-Center Phase I/II Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Degenerative Disc Disease
Disc Degeneration
Lumbar Discogenic Pain
Keywords: Degenerative Disc Disease
Lumbar Discogenic Pain
Lead sponsor: VIVEX Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 110
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: At the 12-week follow-up, all participants will remain blinded and will be given the option to be considered for crossover. Only participants allocated to the needle sham control group will be given the option to crossover into the VIA Disc NP group at the 12-week visit if they meet the following requirement:

The participant has not experienced at least a 30% reduction in pain severity as determined by their 12-week VAS score

Sham participants who crossover into the VIA Disc NP group will receive an injection of VIA Disc NP and continue in the study.
Primary purpose: OTHER

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 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)

Primary outcomes:
measure: Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from Baseline to 26 weeks.
timeFrame: Baseline to 26 Weeks
measure: Primary Safety Endpoint - Proportion of participants reporting Treatment-related AEs at 12 weeks
timeFrame: Baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Genesis Research Services Pty Ltd
state: New South Wales
city: Hurstville
country: Australia
facility: Australian Medical Research
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Pain Research Centre
state: New South Wales
city: Wayville
country: Australia
facility: Cercare Clinical Research
state: South Australia
city: Clayton
country: Australia
facility: Monash Clinical Research Pty Ltd
state: Victoria
Study officials:
References: