CD133+ Autologous Cells After Myocardial Infarction - Full Text View

Sponsored by:	Fondazione Ospedale Maggiore Policlinico Milano
Information provided by:	Fondazione Ospedale Maggiore Policlinico Milano
ClinicalTrials.gov Identifier:	NCT00400959

Purpose

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.

Condition	Intervention	Phase
Acute Myocardial Infarction	Procedure: cd133+cell intracoronary administration	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by Fondazione Ospedale Maggiore Policlinico Milano:

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;

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

Estimated Enrollment:	15
Study Start Date:	June 2004
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400959

Locations

Italy
Cell Factory, department of regenerative medicine, Policlinic of Milan
Milan, Italy

Sponsors and Collaborators

Fondazione Ospedale Maggiore Policlinico Milano

Investigators

Principal Investigator:

Rosaria Giordano, MD

Cell Factory Department of Regenerative Medicine Policlinic Milan

More Information

No publications provided

Study ID Numbers:	CFT92002
Study First Received:	November 14, 2006
Last Updated:	November 15, 2006
ClinicalTrials.gov Identifier:	NCT00400959 History of Changes
Health Authority:	Italy: National Institute of Health

Keywords provided by Fondazione Ospedale Maggiore Policlinico Milano:

cell therapy
acute myocardial infarction

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on September 03, 2009