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

NCT03709901 | Unknown DMC

• 1 other identifier: VAST - 001-017
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 13

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.

Conditions

Degenerative Disc Disease

Keywords

Chronic Lumbar Back Pain; Low Back Pain; Back Pain; Degenerative Disc Disease; Intervertebral Disc Degeneration

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• MRI Assessments

  Baseline, 6 Months, and 12 Months

• X-Ray Assessments

  Baseline, 6 Months, and 12 Months

• 36-Item Short Form Survey (SF-36) Questionnaire

  Baseline, 6 Months, and 12 Months

• Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Through study completion, an average of 12 months

• Resource Utilization Questionnaire

  Baseline, 6 Months, and 12 Months

Study Arms (3)

Active Allograft

EXPERIMENTAL

Injection of viable allograft

Other: Active Allograft

Placebo

PLACEBO COMPARATOR

Injection of saline

Other: Placebo

Conservative Care

NO INTERVENTION

Continued conservative care treatment

Interventions

Active Allograft OTHER

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

Also known as: viable allograft disc injection, cellular allograft nucleus pulposus matrix

Active Allograft

Placebo OTHER

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

Also known as: Saline injection, Placebo control

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VIVEX Biologics, Inc.: lead

Study Sites (13)

Source Health

Santa Monica, California, 90404, United States

Location

IPM Medical Group

Walnut Creek, California, 94598, United States

Location

Laser Spine Institute

Tampa, Florida, 33607, United States

Location

Athens Orthopedic Clinic

Athens, Georgia, 30606, United States

Location

Neurological Institute of Savannah

Savannah, Georgia, 31405, United States

Location

OrthoIndy

Indianapolis, Indiana, 46278, United States

Location

Michigan Spine Clinic

Brownstown, Michigan, 48183, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

Clinical Investigations, LLC

Edmond, Oklahoma, 73013, United States

Location

Invictus Healthcare

Tulsa, Oklahoma, 74133, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

Virginia iSpine Physicians

Richmond, Virginia, 23235, United States

Location

Gershon Pain Specialists

Virginia Beach, Virginia, 23454, United States

Location

Related Publications (3)

• 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.

  PMID: 34875850 DERIVED

• 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.

  PMID: 34554689 DERIVED

• 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.

  PMID: 32355632 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain; Back Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Timothy Ganey, PhD

  VIVEX Biologics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, prospective, randomized, parallel-arm study.

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 17, 2018
• Study Start: August 22, 2017
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: July 7, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)