Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain With or Without Intervertebral Disc Herniation - VAST Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- VIVEX Biologics, Inc.
- Enrollment
- 218
- Locations
- 25
- Primary Endpoint
- Visual Analogue Scale of Pain Intensity (VASPI)
Study Overview
Brief Summary
The objective of this study is to evaluate the safety and efficacy of viable allograft transplantation for the treatment of patients with symptomatic disc degeneration and tissue loss.
All subjects randomized to Active Allograft will undergo injection of a viable allograft into the nucleus pulposus of the degenerated disc. All subjects randomized to Placebo will undergo injection with saline into the nucleus pulposus of the degenerated disc. All subjects randomized to Conservative Care will continue standard of care, with the opportunity to crossover at 3 months into the Active Allograft arm.
Detailed Description
This is a multicenter, prospective, parallel arm study to assess patients who participated in the VAST trial and receiving either viable allograft, saline, or allograft after cross-over. These patients will be evaluated at baseline, injection, 6 months, and 12 months. Subjects will then have an option for a 24 months and 36 months extension after their index procedures. Patients who received saline or active allograft in the VAST study will be allowed to receive viable allograft and followed for an additional 12 and 24 months after that election. These subjects will need to meet initial inclusion/exclusion criteria again before another injection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The assignment to treatment (active allograft, or placebo, or conservative care) is open label at Day 0 of the Active Phase to the extent that subjects receiving allograft or placebo will not be aware of what they have received, while those assigned to conservative care will be aware. All site study staff will be aware of the group to which each subject is randomized. Sites will be trained to ensure that subjects receiving the allograft or placebo treatment will remain blinded to their treatment throughout the study duration.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Able to provide an English written Informed Consent
- •Age 18 to 60 years inclusive
- •Male or female
- •Body mass index <35
- •Pfirrmann Grade [3-6]
- •Radiographic confirmation by MRI/X-ray of:
- •translational instability defined as ≤5 mm, or
- •angular instability defined as ≤5°
- •Back pain (with or without radicular leg pain) measured by:
- •ODI of at least 40%, and
- •VASPI of at least 40mm
- •Pathologic level between L1 and S1
- •1 or 2 vertebral level involvement that has been evaluated for at least 6 months and treated with conservative care
- •Symptomatic back pain attributable to intervertebral disc for a minimum of 6 months
- •No previous surgical treatment at the disc level(s) being considered
- •Psychosocially, mentally and physically able to fully comply with this protocol, and follow-up schedule
- •Ability to undergo allograft transplantation
- •Life expectancy >2 years
- •No contraindications to MRI
- •No history of malignancy (basal cell carcinoma) or chronic infectious disease (e.g. HIV, Hepatitis)
- •Agree to use appropriate contraception; not planning on becoming pregnant for 24 months after treatment
- •Patient disc for transplant confirmed by inter-discal pressure measurement, or disc-imaging study.
- •No signs or symptoms of infection
- •No chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs prior to treatment
Exclusion Criteria
- •Seropositive or seronegative spondyloarthropathy
- •Type III Modic changes
- •Prior surgeries of segments between L1 and S1
- •Chemonucleolysis or percutaneous laserectomy of the affected disc prior to the study
- •Chronic facet syndrome
- •Stenosis of the spinal canal that is moderate to severe or more in degree
- •Spondylodiscitis
- •Spondylolisthesis (lysis and degenerative)
- •Severe motor deficit or cauda equina disorder based on investigator determination
- •Congenital abnormalities of the spinal nerves
- •Pelvic and inguinal angiopathy
- •Neurogenic inguinal syndrome
- •Syringomyelia
- •Diastematomyelia
- •Traumatic neurological disorders
- •Diseases of the kidney (nephritis, pyelonephritis)
- •Other severe diseases of any other major body system as judged by the investigator
- •Regular intake of systemic steroids
- •Malignant diseases of any solid organ or any hematologic malignancy during the previous 5 years
- •Patients who have participated in a clinical trial within the last month prior to inclusion
- •Moderate to severe or greater lumbar stenosis of both transplantation endplates and adjacent levels
Outcomes
Primary Outcomes
Visual Analogue Scale of Pain Intensity (VASPI)
Time Frame: 36 Months
To evaluate the mean change from 12 months in chronic lumbar back pain scores on the Visual Analogue Scale of Pain Intensity (VASPI) measured from 0mm (no pain) to 100mm (worst pain).
Oswestry Disability Index (ODI)
Time Frame: 36 Months
To evaluate the mean change from 12 months in functional durability on the Oswestry
Secondary Outcomes
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(Through study completion, an average of 12 months)
- MRI Assessments(Baseline, 6 Months, and 12 Months)
- X-Ray Assessments(Baseline, 6 Months, and 12 Months)
- Oswestry Disability Index (ODI)(6 and 12 Months)
- 36-Item Short Form Survey (SF-36) Questionnaire(Baseline, 6 Months, and 12 Months)
- Resource Utilization Questionnaire(Baseline, 6 Months, and 12 Months)