drugset / Trial / NCT02846883

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

NCT02846883 ↗

Phase 1 Terminated 28 enrolled VA Office of Research and Development
RandomizedParallel-groupTriple-blindTreatment

Summary

This project is to determine the safety and explore the effectiveness of allogeneic (not cells of the participant but those of another human) mesenchymal stromal cells (MSCs) in decreasing inflammation and possible enlargement of the participants' abdominal aortic aneurysm. Participants will be selected as a possible subject because of an abdominal aortic aneurysm discovered on the ultrasound or computed tomographic ("CT") scan requested by the participants' doctor. The purpose of this study is to collect information that will be used to determine if MSCs can be used to decrease inflammation and possibly slow down enlargement of the participants' aneurysm. The investigators will also be collecting blood samples to study special inflammatory cells that cause aneurysms as well as asking participants to have a "PET" (positron emission tomography) scan that can measure inflammation directly in the participants' aneurysm.

Timeline

Start
2016-12-05
Primary completion
2021-09-30
Completion
2021-09-30

Outcome

Outcome not reported

Stopped (Enrollment): “Early Termination as required by VA DSMB due to slow enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Comparator mesenchymal stromal cells Cell therapy 1e+06 cells/kg Intravenous
Comparator mesenchymal stromal cells Cell therapy 3e+06 cells/kg Intravenous