Acute Myocardial Infarction
Conditions
Keywords
cell therapy, acute myocardial infarction
Brief 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.
Interventions
PROCEDUREcd133+cell intracoronary administration
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent; * age: 18-65 years; * large acute myocardial infarction (due to proximal occlusion of the left anterior descending or the right coronary artery) after successful primary PTCA carried out between the IV and the XXIV hour from the onset of AMI symptoms; * signs of microvascular dysfunction in the infarcted area: absence of STeR and angiographic MB, graded according to the dye density score (see van't Hof et al., Circulation, 1998); life expectancy more than 6 months.
Exclusion criteria
* Pregnancy; * indication to aorto-coronaric by-pass; * neoplasia (previous or in progress); * primary diseases of the BM; * diabetes; * immunosuppressive therapy; * laboratory alterations of protein S, protein C, ATIII or Fibrinogen; * severe co-morbidity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3), | — |
| Ejection fraction (%) evaluated by 2D echocardiography; | — |
Secondary
| Measure | Time frame |
|---|---|
| perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG); | — |
| Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D | — |
Countries
Italy
Outcome results
None listed