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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Other: Active Allograft
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-center, prospective, randomized, parallel-arm study.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lumbar Back Pain, Low Back Pain, Back Pain, Degenerative Disc Disease, Intervertebral Disc Degeneration