CD133+ Autologous Cells After Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title: Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction

Status Completed

Clinical Trial Summary

TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction.

TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.

SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002).

OBJECTIVES Primary:

1. To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.

2. To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls.

Secondary:

3. To evaluate the disease-related morbility of the target population.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

• NCT number: NCT00400959
• Study type: Interventional
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2004
• Completion date: October 2006