Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction (REGEN-AMI)

NCT00765453 NA COMPLETED

Study hypothesis : The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone. Aims * To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure * To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography. * To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.

Details

Lead sponsor	Barts & The London NHS Trust
Phase	NA
Status	COMPLETED
Enrolment	100
Start date	2008-03
Completion	2018-03

Conditions

• Acute Myocardial Infarction

Interventions

• Bone marrow derived progenitor cells or placebo infusion
• Placebo infusion

Primary outcomes

• Longitudinal change in left ventricular function (ejection fraction) — 1 year

Countries

Denmark, Switzerland, United Kingdom