Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain (VAST)

Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain With or Without Intervertebral Disc Herniation - VAST Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Other: Active Allograft; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Source Health
    • Walnut Creek, California, United States, 94598
      • IPM Medical Group
  • Florida
    • Tampa, Florida, United States, 33607
      • Laser Spine Institute
  • Georgia
    • Athens, Georgia, United States, 30606
      • Athens Orthopedic Clinic
    • Savannah, Georgia, United States, 31405
      • Neurological Institute of Savannah
  • Indiana
    • Indianapolis, Indiana, United States, 46278
      • OrthoIndy
  • Michigan
    • Brownstown, Michigan, United States, 48183
      • Michigan Spine Clinic
  • New York
    • New York, New York, United States, 10022
      • Ainsworth Institute of Pain Management
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Clinical Investigations, LLC
    • Tulsa, Oklahoma, United States, 74133
      • Invictus Healthcare
  • Texas
    • Plano, Texas, United States, 75093
      • Texas Back Institute
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Virginia iSpine Physicians
    • Virginia Beach, Virginia, United States, 23454
      • Gershon Pain Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Allograft; Injection of viable allograft	Other: Active Allograft; Injection of viable allograft into the nucleus pulposus of the degenerated disc; Other Names: viable allograft disc injection; cellular allograft nucleus pulposus matrix
Placebo Comparator: Placebo; Injection of saline	Other: Placebo; Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc; Other Names: Placebo control; Saline injection
No Intervention: Conservative Care; Continued conservative care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	To evaluate the mean change from baseline in functional disability on the Oswestry Disability Index (ODI) measured from 0 (minimal disability) to 100 (maximal disability).	6 Months
Oswestry Disability Index (ODI)	To evaluate the mean change from baseline in functional disability on the Oswestry Disability Index (ODI) measured from 0 (minimal disability) to 100 (maximal disability).	12 Months
Visual Analogue Scale of Pain Intensity (VASPI)	To evaluate the mean change from baseline in chronic lumbar back pain scores on the Visual Analogue Scale of Pain Intensity (VASPI) measured from 0mm (no pain) to 100mm (worst pain).	6 Months
Visual Analogue Scale of Pain Intensity (VASPI)	To evaluate the mean change from baseline in chronic lumbar back pain scores on the Visual Analogue Scale of Pain Intensity (VASPI) measured from 0mm (no pain) to 100mm (worst pain).	12 Months
Oswestry Disability Index (ODI)	To evaluate the mean change from 12 months in functional durability on the Oswestry	24 Months
Oswestry Disability Index (ODI)	To evaluate the mean change from 12 months in functional durability on the Oswestry	36 Months
Visual Analogue Scale of Pain Intensity (VASPI)	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).	24 Months
Visual Analogue Scale of Pain Intensity (VASPI)	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).	36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI Assessments	To evaluate morphologic changes of treated intervertebral discs using MRI assessments.	Baseline, 6 Months, and 12 Months
X-Ray Assessments	To evaluate morphologic changes of treated intervertebral discs using X-ray assessments.	Baseline, 6 Months, and 12 Months
36-Item Short Form Survey (SF-36) Questionnaire	To evaluate results of the SF-36 Questionnaire.	Baseline, 6 Months, and 12 Months
Adverse Events (AEs) and Serious Adverse Events (SAEs)	To evaluate the number of participants with treatment-related adverse events (AEs) and serious adverse events (SAEs).	Through study completion, an average of 12 months
Resource Utilization Questionnaire	To evaluate results of the resource utilization questionnaire.	Baseline, 6 Months, and 12 Months
Oswestry Disability Index (ODI)	To evaluate results of the ODI for improvement after treatment	6 and 12 Months

Collaborators and Investigators

• Sponsor: VIVEX Biologics, Inc.
• Investigators: Study Director: Timothy Ganey, PhD, VIVEX Biologics, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2017
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Low Back Pain; Degenerative Disc Disease; Back Pain; Chronic Lumbar Back Pain; Intervertebral Disc Degeneration
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Intervertebral Disc Degeneration
• Other Study ID Numbers: VAST - 001-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No