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

NCT ID: NCT03709901

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-22
• Study Completion Date: 2022-01-31

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.

Conditions

Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active Allograft

Injection of viable allograft

Group Type: EXPERIMENTAL

Active Allograft

Intervention Type: OTHER

Injection of viable allograft into the nucleus pulposus of the degenerated disc

Placebo

Injection of saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc

Conservative Care

Continued conservative care treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Active Allograft

Injection of viable allograft into the nucleus pulposus of the degenerated disc

Intervention Type: OTHER

Placebo

Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc

Intervention Type: OTHER

Other Intervention Names

viable allograft disc injection; cellular allograft nucleus pulposus matrix; Saline injection; Placebo control

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VIVEX Biologics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Ganey, PhD

Role: STUDY_DIRECTOR

VIVEX Biologics, Inc.

Locations

Source Health

Santa Monica, California, United States

IPM Medical Group

Walnut Creek, California, United States

Laser Spine Institute

Tampa, Florida, United States

Athens Orthopedic Clinic

Athens, Georgia, United States

Neurological Institute of Savannah

Savannah, Georgia, United States

OrthoIndy

Indianapolis, Indiana, United States

Michigan Spine Clinic

Brownstown, Michigan, United States

Ainsworth Institute of Pain Management

New York, New York, United States

Clinical Investigations, LLC

Edmond, Oklahoma, United States

Invictus Healthcare

Tulsa, Oklahoma, United States

Texas Back Institute

Plano, Texas, United States

Virginia iSpine Physicians

Richmond, Virginia, United States

Gershon Pain Specialists

Virginia Beach, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34875850 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34554689 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32355632 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VAST - 001-017

Identifier Type: -

Identifier Source: org_study_id