Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709901
Recruitment Status : Active, not recruiting
First Posted : October 17, 2018
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Vivex Biomedical, Inc.

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.


Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Other: Active Allograft Other: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, prospective, randomized, parallel-arm study.
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.
Primary Purpose: Treatment
Official Title: Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain With or Without Intervertebral Disc Herniation - VAST Trial
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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:
  • Saline injection
  • Placebo control

No Intervention: Conservative Care
Continued conservative care treatment



Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 6 Months ]
    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).

  2. Oswestry Disability Index (ODI) [ Time Frame: 12 Months ]
    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).

  3. Visual Analogue Scale of Pain Intensity (VASPI) [ Time Frame: 6 Months ]
    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).

  4. Visual Analogue Scale of Pain Intensity (VASPI) [ Time Frame: 12 Months ]
    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).

  5. Oswestry Disability Index (ODI) [ Time Frame: 24 Months ]
    To evaluate the mean change from 12 months in functional durability on the Oswestry

  6. Oswestry Disability Index (ODI) [ Time Frame: 36 Months ]
    To evaluate the mean change from 12 months in functional durability on the Oswestry

  7. Visual Analogue Scale of Pain Intensity (VASPI) [ Time Frame: 24 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).

  8. 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).


Secondary Outcome Measures :
  1. MRI Assessments [ Time Frame: Baseline, 6 Months, and 12 Months ]
    To evaluate morphologic changes of treated intervertebral discs using MRI assessments.

  2. X-Ray Assessments [ Time Frame: Baseline, 6 Months, and 12 Months ]
    To evaluate morphologic changes of treated intervertebral discs using X-ray assessments.

  3. 36-Item Short Form Survey (SF-36) Questionnaire [ Time Frame: Baseline, 6 Months, and 12 Months ]
    To evaluate results of the SF-36 Questionnaire.

  4. Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Through study completion, an average of 12 months ]
    To evaluate the number of participants with treatment-related adverse events (AEs) and serious adverse events (SAEs).

  5. Resource Utilization Questionnaire [ Time Frame: Baseline, 6 Months, and 12 Months ]
    To evaluate results of the resource utilization questionnaire.

  6. Oswestry Disability Index (ODI) [ Time Frame: 6 and 12 Months ]
    To evaluate results of the ODI for improvement after treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709901


Locations
Layout table for location information
United States, California
Orthopedic Pain Specilaists
Santa Monica, California, United States, 90404
IPM Medical Group
Walnut Creek, California, United States, 94598
United States, Florida
Laser Spine Institute
Tampa, Florida, United States, 33607
United States, Georgia
Athens Orthopedic Clinic
Athens, Georgia, United States, 30606
Neurological Institute of Savannah
Savannah, Georgia, United States, 31405
United States, Indiana
OrthoIndy
Indianapolis, Indiana, United States, 46278
United States, Michigan
Michigan Spine Clinic
Brownstown, Michigan, United States, 48183
United States, New York
Ainsworth Institute of Pain Management
New York, New York, United States, 10022
United States, Oklahoma
Clinical Investigations, LLC
Edmond, Oklahoma, United States, 73013
Invictus Healthcare
Tulsa, Oklahoma, United States, 74133
United States, Texas
Texas Back Institute
Plano, Texas, United States, 75093
United States, Virginia
Virginia iSpine Physicians
Richmond, Virginia, United States, 23235
Gershon Pain Specialists
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
Vivex Biomedical, Inc.
Investigators
Layout table for investigator information
Study Director: Timothy Ganey, PhD Vivex Biomedical, Inc.
  Study Documents (Full-Text)

Documents provided by Vivex Biomedical, Inc.:
Study Protocol  [PDF] December 9, 2019
Statistical Analysis Plan  [PDF] January 30, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Vivex Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT03709901    
Other Study ID Numbers: VAST - 001-017
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vivex Biomedical, Inc.:
Chronic Lumbar Back Pain
Low Back Pain
Back Pain
Degenerative Disc Disease
Intervertebral Disc Degeneration
Additional relevant MeSH terms:
Layout table for MeSH terms
Intervertebral Disc Degeneration
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases