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Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms — VIVAAA  

Peripheral Artery Disease Clinical Trial

Official title:
A Phase I Study to Examine the Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cell Immune Suppressor Function in Patients With Small Abdominal Aortic Aneurysms (AAA)

Clinical Trial Summary

This study will assess the safety and efficacy of systemic (IV) administration of escalating doses of allogeneic MSCs in modulating immune cell phenotypes and suppressing aortic inflammation in patients with small AAA. Subjects will be randomized in a 1:1:1 fashion to receive mesenchymal stromal cells (1 million or 3 million MSC/kg) intra-venously or placebo (Plasmalyte A).

Clinical Trial Description

This is a phase I, double blinded trial that will enroll 36 patients with AAA measuring 35-45 mm in maximal transverse diameter (MTD). This study will assess the safety of MSCs in doses of 1 million MSCs/kg. or 3 million MSCs/kg. delivered intra-venously. This trial test the hypothesis that MSCs, in a dose dependent fashion, promote the frequency and immune suppressor function of CD4+CD25+ FoxP3+ T-regulatory cells and decrease AAA inflammation as measured by 18-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT). The primary safety endpoints will be incidence of treatment related adverse events accrued over 24 months. Efficacy measures are changes in frequency and immune suppressor function of Tregs, number and cytotoxic activity of CD4+/CD8+ CD28- T-cells, activated monocytes, and changes in aortic inflammation as measured by uptake of 18-FDG PET/CT compared to baseline. Incidence of surgical intervention, aneurysm related death, quality of life, and major adverse cardiac events will be recorded. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02843854
Study type Interventional
Source Indiana University
Contact Kristen E Wanczyk, RN,CCRC
Phone 317-988-9548
Email keevans@iu.edu
Status Not yet recruiting
Phase Phase 1
Start date October 2016
Completion date April 2020
View Details
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