Status unknownNCT03709901VASTUpdated Jul 7, 2021

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

An interventional study of Active Allograft and Placebo in Degenerative Disc Disease, sponsored by VIVEX Biologics, Inc.. Status unknown at 13 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-07.

Sponsored by VIVEX Biologics, Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

Registered 1 year 1 month after the study started (first participant enrolled Aug 2017, registered Oct 2018).

Phase: Not applicable
Study type: Interventional
Enrollment: 218
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Degenerative Disc Disease

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Keywords

Chronic Lumbar Back Pain
Low Back Pain
Back Pain
Degenerative Disc Disease
Intervertebral Disc Degeneration

In context

Intervertebral Disc Degeneration

464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.

This study's enrollment of 218 is above the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

VIVEX Biologics, Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: 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:
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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 218 participants (actual)

Study arms

Experimental
Active Allograft
Injection of viable allograft
Other: Active Allograft
Placebo comparator
Placebo
Injection of saline
Other: Placebo
No intervention
Conservative Care
Continued conservative care treatment

Interventions

OtherActive Allograft
Injection of viable allograft into the nucleus pulposus of the degenerated disc
Also known as: viable allograft disc injection, cellular allograft nucleus pulposus matrix
OtherPlacebo
Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc
Also known as: Saline injection, Placebo control

What researchers measure

Primary outcomes

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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 Months
Oswestry Disability Index (ODI)
To evaluate the mean change from 12 months in functional durability on the Oswestry
Time frame: 24 Months
Oswestry Disability Index (ODI)
To evaluate the mean change from 12 months in functional durability on the Oswestry
Time frame: 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).
Time frame: 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).
Time frame: 36 Months

Secondary outcomes

MRI Assessments
To evaluate morphologic changes of treated intervertebral discs using MRI assessments.
Time frame: Baseline, 6 Months, and 12 Months
X-Ray Assessments
To evaluate morphologic changes of treated intervertebral discs using X-ray assessments.
Time frame: Baseline, 6 Months, and 12 Months
36-Item Short Form Survey (SF-36) Questionnaire
To evaluate results of the SF-36 Questionnaire.
Time frame: 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).
Time frame: Through study completion, an average of 12 months
Resource Utilization Questionnaire
To evaluate results of the resource utilization questionnaire.
Time frame: Baseline, 6 Months, and 12 Months
Oswestry Disability Index (ODI)
To evaluate results of the ODI for improvement after treatment
Time frame: 6 and 12 Months

Study locations

13 sites

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

References and documents

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. PubMed 34875850 ↗
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. PubMed 34554689 ↗
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. PubMed 32355632 ↗

Study documents

Study protocol · Dec 9, 2019
Statistical analysis plan · Jan 30, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03709901
Lead sponsor: VIVEX Biologics, Inc.
Responsible party: Sponsor
First posted: Oct 17, 2018
Start date: Aug 22, 2017
Primary completion: Jan 31, 2022 (estimated)
Completion: Jan 31, 2022 (estimated)
Last update: Jul 7, 2021

Study contacts

Timothy Ganey, PhD

study director · VIVEX Biologics, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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