CD133+ Autologous Cells After Myocardial Infarction - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 14, 2006

Last Updated Date

November 15, 2006

Start Date ^†

June 2004

Current Primary Outcome Measures ^†

myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),
Ejection fraction (%) evaluated by 2D echocardiography;

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00400959 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);
Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

CD133+ Autologous Cells After Myocardial Infarction

Official Title ^†

Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After 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:

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

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Acute Myocardial Infarction

Intervention ^†

Procedure: cd133+cell intracoronary administration

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^†

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00400959

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Fondazione Ospedale Maggiore Policlinico Milano

Collaborators ^††

Investigators ^†

Principal Investigator:

Rosaria Giordano, MD

Cell Factory Department of Regenerative Medicine Policlinic Milan

Information Provided By

Fondazione Ospedale Maggiore Policlinico Milano

Verification Date

November 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.