CD133+ Autologous Cells After Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400959
• Other study ID #: CFT92002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 14, 2006
• Last updated: November 15, 2006
• Start date: June 2004
• Est. completion date: October 2006

Study information

• Verified date: November 2006
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

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

Intervention

Procedure:
• cd133+cell intracoronary administration

Locations

Country	Name	City	State
Italy	Cell Factory, department of regenerative medicine, Policlinic of Milan	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),
Primary	Ejection fraction (%) evaluated by 2D echocardiography;
Secondary	perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);
Secondary	Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D