Degenerative Disc Disease
Conditions
Keywords
Chronic Lumbar Back Pain, Low Back Pain, Back Pain, Degenerative Disc Disease, Intervertebral Disc Degeneration
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.
Interventions
OTHERActive Allograft
Injection of viable allograft into the nucleus pulposus of the degenerated disc
OTHERPlacebo
Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc
Sponsors
VIVEX Biologics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention model description
Multi-center, prospective, randomized, parallel-arm study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | 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). |
| Visual Analogue Scale of Pain Intensity (VASPI) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 36-Item Short Form Survey (SF-36) Questionnaire | Baseline, 6 Months, and 12 Months | To evaluate results of the SF-36 Questionnaire. |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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). |
| MRI Assessments | Baseline, 6 Months, and 12 Months | To evaluate morphologic changes of treated intervertebral discs using MRI assessments. |
| Oswestry Disability Index (ODI) | 6 and 12 Months | To evaluate results of the ODI for improvement after treatment |
| Resource Utilization Questionnaire | Baseline, 6 Months, and 12 Months | To evaluate results of the resource utilization questionnaire. |
| X-Ray Assessments | Baseline, 6 Months, and 12 Months | To evaluate morphologic changes of treated intervertebral discs using X-ray assessments. |
Countries
United States
Outcome results
None listed