drugset / Trial / NCT00747708

Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure

NCT00747708

Phase 2/3 Completed 148 enrolled Barts & The London NHS Trust
RandomizedSingle-groupTriple-blindTreatment

Summary

The purpose of this study is to determine whether adult bone marrow derived stem/progenitor cells improve cardiac function and symptoms in patients with heart failure and to establish the optimal method of delivery of these cells. Study hypotheses: * Administration of G-CSF to patients with heart failure secondary to ischaemic heart disease will lead to an increase in circulating progenitor cells as measured by peripheral CD34+ positive cell counts * Cardiac function and symptoms will improve in patients in whom the peripheral CD34+ counts increase in response to G-CSF administration * Direct coronary injection of autologous bone marrow derived stem cells will confer an additional improvement in cardiac function and symptoms above that derived from G-CSF infusion alone * Direct intramyocardial injection of autologous bone marrow derived stem cells will lead to an improvement in cardiac function and symptoms above that derived from G-CSF infusion alone

Timeline

Start
2005-08
Primary completion
2012-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Granulocyte colony-stimulating factor Protein / enzyme biologic Subcutaneous