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Tissue Transplantation
Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain (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
Summary
This trial is testing if injecting healthy donor tissue into damaged spinal discs can help patients with back pain and disc degeneration. The goal is to see if this treatment can repair the discs and reduce symptoms.
Eligible Conditions
- Degenerative Disc Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visual Analogue Scale of Pain Intensity (VASPI)
Secondary study objectives
36-Item Short Form Survey (SF-36) Questionnaire
Adverse Events (AEs) and Serious Adverse Events (SAEs)
MRI Assessments
+3 moreTrial 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
8 Previous Clinical Trials
781 Total Patients Enrolled
Timothy Ganey, PhDStudy DirectorVIVEX Biologics, Inc.