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

Not Applicable

• Conditions: Degenerative Disc Disease
• Interventions: Other: Placebo; Other: Active Allograft

• Registration Number: NCT03709901
• Lead Sponsor: VIVEX Biologics, Inc.

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.

Study Timeline

• Study Start: 2017-08-22
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Status Verified: 2021-04
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-07
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Injection of saline
Active Allograft	Active Allograft	Injection of viable allograft

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale of Pain Intensity (VASPI)	36 Months	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).
Oswestry Disability Index (ODI)	36 Months	To evaluate the mean change from 12 months in functional durability on the Oswestry

Secondary Outcome Measures

Name	Time	Method
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).
Oswestry Disability Index (ODI)	6 and 12 Months	To evaluate results of the ODI for improvement after treatment
MRI Assessments	Baseline, 6 Months, and 12 Months	To evaluate morphologic changes of treated intervertebral discs using MRI assessments.
X-Ray Assessments	Baseline, 6 Months, and 12 Months	To evaluate morphologic changes of treated intervertebral discs using X-ray assessments.
36-Item Short Form Survey (SF-36) Questionnaire	Baseline, 6 Months, and 12 Months	To evaluate results of the SF-36 Questionnaire.
Resource Utilization Questionnaire	Baseline, 6 Months, and 12 Months	To evaluate results of the resource utilization questionnaire.

Trial Locations

Locations (13)

OrthoIndy; 🇺🇸 Indianapolis, Indiana, United States

Source Health; 🇺🇸 Santa Monica, California, United States

Gershon Pain Specialists; 🇺🇸 Virginia Beach, Virginia, United States

Texas Back Institute; 🇺🇸 Plano, Texas, United States

Laser Spine Institute; 🇺🇸 Tampa, Florida, United States

IPM Medical Group; 🇺🇸 Walnut Creek, California, United States

Athens Orthopedic Clinic; 🇺🇸 Athens, Georgia, United States

Neurological Institute of Savannah; 🇺🇸 Savannah, Georgia, United States

Ainsworth Institute of Pain Management; 🇺🇸 New York, New York, United States

Michigan Spine Clinic; 🇺🇸 Brownstown, Michigan, United States

Clinical Investigations, LLC; 🇺🇸 Edmond, Oklahoma, United States

Invictus Healthcare; 🇺🇸 Tulsa, Oklahoma, United States

Virginia iSpine Physicians; 🇺🇸 Richmond, Virginia, United States