Degenerative Disc DiseaseVASTNCT03709901
Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain
A study testing Active Allograft in people with Degenerative Disc Disease, run by VIVEX Biologics, Inc. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Active Allograft
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 13 sitesUnited States
- Study dates
- 22 Aug 2017to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Athens Orthopedic Clinic
Athens, Georgia, 30606
Michigan Spine Clinic
Brownstown, Michigan, 48183
Clinical Investigations, LLC
Edmond, Oklahoma, 73013
OrthoIndy
Indianapolis, Indiana, 46278
Ainsworth Institute of Pain Management
New York, New York, 10022
Texas Back Institute
Plano, Texas, 75093
Virginia iSpine Physicians
Richmond, Virginia, 23235
Source Health
Santa Monica, California, 90404
Neurological Institute of Savannah
Savannah, Georgia, 31405
Laser Spine Institute
Tampa, Florida, 33607
Invictus Healthcare
Tulsa, Oklahoma, 74133
Gershon Pain Specialists
Virginia Beach, Virginia, 23454
IPM Medical Group
Walnut Creek, California, 94598
About this study
Official title: 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.
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
- Degenerative Disc Disease
- Being tested
- Active Allograft, Placebo
- Keywords
- Chronic Lumbar Back Pain, Low Back Pain, Back Pain, Degenerative Disc Disease, Intervertebral Disc Degeneration
- Medical subject headings
- Intervertebral Disc Degeneration, Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active AllograftOther
Also called viable allograft disc injection, cellular allograft nucleus pulposus matrix
Injection of viable allograft into the nucleus pulposus of the degenerated disc
PlaceboOther
Also called Saline injection, Placebo control
Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc
| Study group | Role | What they receive |
|---|---|---|
| Active Allograft | Experimental | Injection of viable allograft Receives: Other: Active Allograft |
| Placebo | Placebo comparator | Injection of saline Receives: Other: Placebo |
| Conservative Care | No intervention | Continued conservative care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 Months
Oswestry Disability Index (ODI)
To evaluate the mean change from 12 months in functional durability on the Oswestry
Measured: 24 Months
Oswestry Disability Index (ODI)
To evaluate the mean change from 12 months in functional durability on the Oswestry
Measured: 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).
Measured: 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).
Measured: 36 Months
Secondary outcomes (6)
MRI Assessments
To evaluate morphologic changes of treated intervertebral discs using MRI assessments.
Measured: Baseline, 6 Months, and 12 Months
X-Ray Assessments
To evaluate morphologic changes of treated intervertebral discs using X-ray assessments.
Measured: Baseline, 6 Months, and 12 Months
36-Item Short Form Survey (SF-36) Questionnaire
To evaluate results of the SF-36 Questionnaire.
Measured: 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).
Measured: Through study completion, an average of 12 months
Resource Utilization Questionnaire
To evaluate results of the resource utilization questionnaire.
Measured: Baseline, 6 Months, and 12 Months
Oswestry Disability Index (ODI)
To evaluate results of the ODI for improvement after treatment
Measured: 6 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start22 Aug 2017
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, prospective, randomized, parallel-arm study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVEX Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Ganey, PhD, Study director, VIVEX Biologics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709901
- Sponsor's protocol ID
- VAST - 001-017
- Acronym
- VAST
- Status last verified
- Apr 2021
- First submitted
- 11 Oct 2018
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34875850Beall 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 34554689Beall 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 at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain With or Without Intervertebral Disc Herniation - VAST Trial
- ClinicalTrials.gov ID
- NCT03709901
- Acronym / sponsor ID
- VAST / VAST - 001-017
- Conditions
- Degenerative Disc Disease
- Keywords
- Chronic Lumbar Back Pain, Low Back Pain, Back Pain, Degenerative Disc Disease, Intervertebral Disc Degeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (actual)
- Lead sponsor
- VIVEX Biologics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Multi-center, prospective, randomized, parallel-arm study.
| Arm | Type | Receives |
|---|---|---|
| Active Allograft | Experimental | Other: Active AllograftInjection of viable allograft |
| Placebo | Placebo comparator | Other: PlaceboInjection of saline |
| Conservative Care | No intervention | –Continued conservative care treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- 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]
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active AllograftAlso: viable allograft disc injection, cellular allograft nucleus pulposus matrixInjection of viable allograft into the nucleus pulposus of the degenerated disc | Other | Active Allograft |
| PlaceboAlso: Saline injection, Placebo controlInjection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc | Other | Placebo |
Primary outcome
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).
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).
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).
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).
Oswestry Disability Index (ODI)
Time frame: 24 Months
To evaluate the mean change from 12 months in functional durability on the Oswestry
Oswestry Disability Index (ODI)
Time frame: 36 Months
To evaluate the mean change from 12 months in functional durability on the Oswestry
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).
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).
6 secondary outcomes
MRI Assessments
Time frame: Baseline, 6 Months, and 12 Months
X-Ray Assessments
Time frame: Baseline, 6 Months, and 12 Months
36-Item Short Form Survey (SF-36) Questionnaire
Time frame: Baseline, 6 Months, and 12 Months
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Through study completion, an average of 12 months
Resource Utilization Questionnaire
Time frame: Baseline, 6 Months, and 12 Months
Oswestry Disability Index (ODI)
Time frame: 6 and 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Derived from this study: PubMed 34875850Hunter 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.
- Derived from this study: PubMed 34554689Beall 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.
- Derived from this study: PubMed 32355632Beall 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Ganey, PhD study director
VIVEX Biologics, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Allograft in people with Degenerative Disc Disease, run by VIVEX Biologics, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: 6 Months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709901, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.