drugset / Trial / NCT00869024

Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement

NCT00869024

Phase 1/2 Completed 25 enrolled University of Minnesota
RandomizedSingle-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if the delivery of cells just after implantation of left ventricular assist device will help to improve the pumping function of your heart and minimize heart enlargement in the future. The cells will be obtained by aspiration or withdrawal of fluid from your bone marrow from your pelvic bone using a needle and syringe. This would not take place until 24-48 hours prior to your planned left ventricular assist device implantation. During the surgery the surgeons will inject the prepared cells that were taken from your bone marrow and inject it into your heart muscle. This study will test whether receiving your own bone marrow cells directly into your heart will help your heart to recover function after placement of a left ventricular assist device.

Timeline

Start
2011-11-10
Primary completion
2016-03-29
Completion
2016-03-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Bone Marrow Derived Mononuclear Cells Cell therapy 0.4 ml Other
Subject Bone Marrow Derived Mononuclear Cells Cell therapy 2e+07 cells Other

Indications