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Tissue Transplantation

Active Allograft for Degenerative Disc Disease (VAST Trial)

N/A
Waitlist Available
Research Sponsored by Vivex Biomedical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights

VAST Trial Summary

This study is evaluating whether a viable allograft can be injected into the nucleus pulposus of a degenerated disc to treat back pain.

Eligible Conditions
  • Degenerative Disc Disease

VAST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analogue Scale of Pain Intensity (VASPI)
Secondary outcome measures
36-Item Short Form Survey (SF-36) Questionnaire
Adverse Events (AEs) and Serious Adverse Events (SAEs)
MRI Assessments
+3 more

VAST Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Active AllograftExperimental Treatment1 Intervention
Injection of viable allograft
Group II: Conservative CareActive Control1 Intervention
Continued conservative care treatment
Group III: PlaceboPlacebo Group1 Intervention
Injection of saline

Find a Location

Who is running the clinical trial?

Vivex Biomedical, Inc.Lead Sponsor
5 Previous Clinical Trials
171 Total Patients Enrolled
VIVEX Biologics, Inc.Lead Sponsor
7 Previous Clinical Trials
671 Total Patients Enrolled
Timothy Ganey, PhDStudy DirectorVIVEX Biologics, Inc.
~28 spots leftby Jun 2025
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