NCT00400959

CD133+ Autologous Cells After Myocardial Infarction

Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (planned)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	cd133+cell intracoronary administration

Timeline

• Start date: 2004-06-01
• Completion: 2006-10-01
• First posted: 2006-11-17
• Last updated: 2006-11-17

Locations

1 site across 1 country: Italy