Clinical trial NCT03709901: Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain
Official title: Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain With or Without Intervertebral Disc Herniation - VAST Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: Chronic Lumbar Back Pain
Low Back Pain
Back Pain
Degenerative Disc Disease
Intervertebral Disc Degeneration
Lead sponsor: VIVEX Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, prospective, randomized, parallel-arm study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

  1. translational instability defined as ≤5 mm, or
  2. angular instability defined as ≤5°
* Back pain (with or without radicular leg pain) measured by:

  1. ODI of at least 40%, and
  2. 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

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 6 Months
measure: Oswestry Disability Index (ODI)
timeFrame: 12 Months
measure: Visual Analogue Scale of Pain Intensity (VASPI)
timeFrame: 6 Months
measure: Visual Analogue Scale of Pain Intensity (VASPI)
timeFrame: 12 Months
measure: Oswestry Disability Index (ODI)
timeFrame: 24 Months
measure: Oswestry Disability Index (ODI)
timeFrame: 36 Months
measure: Visual Analogue Scale of Pain Intensity (VASPI)
timeFrame: 24 Months
measure: Visual Analogue Scale of Pain Intensity (VASPI)
timeFrame: 36 Months
Secondary outcomes:
measure: MRI Assessments
timeFrame: Baseline, 6 Months, and 12 Months
measure: X-Ray Assessments
timeFrame: Baseline, 6 Months, and 12 Months
measure: 36-Item Short Form Survey (SF-36) Questionnaire
timeFrame: Baseline, 6 Months, and 12 Months
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Through study completion, an average of 12 months
measure: Resource Utilization Questionnaire
timeFrame: Baseline, 6 Months, and 12 Months
measure: Oswestry Disability Index (ODI)
timeFrame: 6 and 12 Months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Source Health
state: California
city: Walnut Creek
country: United States
facility: IPM Medical Group
state: California
city: Tampa
country: United States
facility: Laser Spine Institute
state: Florida
city: Athens
country: United States
facility: Athens Orthopedic Clinic
state: Georgia
city: Savannah
country: United States
facility: Neurological Institute of Savannah
state: Georgia
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Brownstown
country: United States
facility: Michigan Spine Clinic
state: Michigan
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Edmond
country: United States
facility: Clinical Investigations, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Invictus Healthcare
state: Oklahoma
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: Richmond
country: United States
facility: Virginia iSpine Physicians
state: Virginia
city: Virginia Beach
country: United States
facility: Gershon Pain Specialists
state: Virginia
Study officials:
affiliation: VIVEX Biologics, Inc.
name: Timothy Ganey, PhD
role: STUDY_DIRECTOR
References:
citation: Hunter CW, Guyer R, Froimson M, DePalma MJ. Effect of age on outcomes after allogeneic disc tissue supplementation in patients with chronic discogenic low back pain in the VAST trial. Pain Manag. 2022 Apr;12(3):301-311. doi: 10.2217/pmt-2021-0078. Epub 2021 Dec 8.
citation: Beall DP, Davis T, DePalma MJ, Amirdelfan K, Yoon ES, Wilson GL, Bishop R, Tally WC, Gershon SL, Lorio MP, Meisel HJ, Langhorst M, Ganey T, Hunter CW. Viable Disc Tissue Allograft Supplementation; One- and Two-level Treatment of Degenerated Intervertebral Discs in Patients with Chronic Discogenic Low Back Pain: One Year Results of the VAST Randomized Controlled Trial. Pain Physician. 2021 Sep;24(6):465-477. No abstract available.
citation: Beall DP, Wilson GL, Bishop R, Tally W. VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease. Int J Spine Surg. 2020 Apr 30;14(2):239-253. doi: 10.14444/7033. eCollection 2020 Apr.