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

Primary Purpose

Degenerative Disc Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Allograft
Placebo
Sponsored by
VIVEX Biologics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Chronic Lumbar Back Pain, Low Back Pain, Back Pain, Degenerative Disc Disease, Intervertebral Disc Degeneration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Source Health
  • IPM Medical Group
  • Laser Spine Institute
  • Athens Orthopedic Clinic
  • Neurological Institute of Savannah
  • OrthoIndy
  • Michigan Spine Clinic
  • Ainsworth Institute of Pain Management
  • Clinical Investigations, LLC
  • Invictus Healthcare
  • Texas Back Institute
  • Virginia iSpine Physicians
  • Gershon Pain Specialists

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Active Allograft

Placebo

Conservative Care

Arm Description

Injection of viable allograft

Injection of saline

Continued conservative care treatment

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
Oswestry Disability Index (ODI)
To evaluate the mean change from 12 months in functional durability on the Oswestry
Oswestry Disability Index (ODI)
To evaluate the mean change from 12 months in functional durability on the Oswestry
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).
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).

Secondary Outcome Measures

MRI Assessments
To evaluate morphologic changes of treated intervertebral discs using MRI assessments.
X-Ray Assessments
To evaluate morphologic changes of treated intervertebral discs using X-ray assessments.
36-Item Short Form Survey (SF-36) Questionnaire
To evaluate results of the SF-36 Questionnaire.
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).
Resource Utilization Questionnaire
To evaluate results of the resource utilization questionnaire.
Oswestry Disability Index (ODI)
To evaluate results of the ODI for improvement after treatment

Full Information

First Posted
October 11, 2018
Last Updated
July 2, 2021
Sponsor
VIVEX Biologics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03709901
Brief Title
Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain
Acronym
VAST
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIVEX Biologics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
Chronic Lumbar Back Pain, Low Back Pain, Back Pain, Degenerative Disc Disease, Intervertebral Disc Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multi-center, prospective, randomized, parallel-arm study.
Masking
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.
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Allograft
Arm Type
Experimental
Arm Description
Injection of viable allograft
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Injection of saline
Arm Title
Conservative Care
Arm Type
No Intervention
Arm Description
Continued conservative care treatment
Intervention Type
Other
Intervention Name(s)
Active Allograft
Other Intervention Name(s)
viable allograft disc injection, cellular allograft nucleus pulposus matrix
Intervention Description
Injection of viable allograft into the nucleus pulposus of the degenerated disc
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline injection, Placebo control
Intervention Description
Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc
Primary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
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).
Time Frame
6 Months
Title
Oswestry Disability Index (ODI)
Description
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).
Time Frame
12 Months
Title
Visual Analogue Scale of Pain Intensity (VASPI)
Description
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).
Time Frame
6 Months
Title
Visual Analogue Scale of Pain Intensity (VASPI)
Description
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).
Time Frame
12 Months
Title
Oswestry Disability Index (ODI)
Description
To evaluate the mean change from 12 months in functional durability on the Oswestry
Time Frame
24 Months
Title
Oswestry Disability Index (ODI)
Description
To evaluate the mean change from 12 months in functional durability on the Oswestry
Time Frame
36 Months
Title
Visual Analogue Scale of Pain Intensity (VASPI)
Description
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).
Time Frame
24 Months
Title
Visual Analogue Scale of Pain Intensity (VASPI)
Description
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).
Time Frame
36 Months
Secondary Outcome Measure Information:
Title
MRI Assessments
Description
To evaluate morphologic changes of treated intervertebral discs using MRI assessments.
Time Frame
Baseline, 6 Months, and 12 Months
Title
X-Ray Assessments
Description
To evaluate morphologic changes of treated intervertebral discs using X-ray assessments.
Time Frame
Baseline, 6 Months, and 12 Months
Title
36-Item Short Form Survey (SF-36) Questionnaire
Description
To evaluate results of the SF-36 Questionnaire.
Time Frame
Baseline, 6 Months, and 12 Months
Title
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
To evaluate the number of participants with treatment-related adverse events (AEs) and serious adverse events (SAEs).
Time Frame
Through study completion, an average of 12 months
Title
Resource Utilization Questionnaire
Description
To evaluate results of the resource utilization questionnaire.
Time Frame
Baseline, 6 Months, and 12 Months
Title
Oswestry Disability Index (ODI)
Description
To evaluate results of the ODI for improvement after treatment
Time Frame
6 and 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Ganey, PhD
Organizational Affiliation
VIVEX Biologics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Source Health
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
IPM Medical Group
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Laser Spine Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Athens Orthopedic Clinic
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
Neurological Institute of Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
OrthoIndy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46278
Country
United States
Facility Name
Michigan Spine Clinic
City
Brownstown
State/Province
Michigan
ZIP/Postal Code
48183
Country
United States
Facility Name
Ainsworth Institute of Pain Management
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Clinical Investigations, LLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Invictus Healthcare
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Virginia iSpine Physicians
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Gershon Pain Specialists
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34875850
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.
Results Reference
derived
PubMed Identifier
34554689
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.
Results Reference
derived
PubMed Identifier
32355632
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.
Results Reference
derived

Learn more about this trial

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

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