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

Degenerative Disc Disease Clinical Trial

— VAST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03709901
• Other study ID #: VAST - 001-017
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 22, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2021
• Source: Vivex Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 218
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Low Back Pain

Intervention

Other:
• Active Allograft
Injection of viable allograft into the nucleus pulposus of the degenerated disc
• Placebo
Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc

Locations

Country	Name	City	State
United States	Athens Orthopedic Clinic	Athens	Georgia
United States	Michigan Spine Clinic	Brownstown	Michigan
United States	Clinical Investigations, LLC	Edmond	Oklahoma
United States	OrthoIndy	Indianapolis	Indiana
United States	Ainsworth Institute of Pain Management	New York	New York
United States	Texas Back Institute	Plano	Texas
United States	Virginia iSpine Physicians	Richmond	Virginia
United States	Source Health	Santa Monica	California
United States	Neurological Institute of Savannah	Savannah	Georgia
United States	Laser Spine Institute	Tampa	Florida
United States	Invictus Healthcare	Tulsa	Oklahoma
United States	Gershon Pain Specialists	Virginia Beach	Virginia
United States	IPM Medical Group	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Vivex Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Oswestry Disability Index (ODI)	To evaluate the mean change from 12 months in functional durability on the Oswestry	24 Months
Primary	Oswestry Disability Index (ODI)	To evaluate the mean change from 12 months in functional durability on the Oswestry	36 Months
Primary	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
Primary	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	MRI Assessments	To evaluate morphologic changes of treated intervertebral discs using MRI assessments.	Baseline, 6 Months, and 12 Months
Secondary	X-Ray Assessments	To evaluate morphologic changes of treated intervertebral discs using X-ray assessments.	Baseline, 6 Months, and 12 Months
Secondary	36-Item Short Form Survey (SF-36) Questionnaire	To evaluate results of the SF-36 Questionnaire.	Baseline, 6 Months, and 12 Months
Secondary	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
Secondary	Resource Utilization Questionnaire	To evaluate results of the resource utilization questionnaire.	Baseline, 6 Months, and 12 Months
Secondary	Oswestry Disability Index (ODI)	To evaluate results of the ODI for improvement after treatment	6 and 12 Months