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CD133+ Autologous Cells After Myocardial Infarction
This study has been completed.
Study NCT00400959   Information provided by Fondazione Ospedale Maggiore Policlinico Milano
First Received: November 14, 2006   Last Updated: November 15, 2006   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

November 14, 2006
November 15, 2006
June 2004
  • myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),
  • Ejection fraction (%) evaluated by 2D echocardiography;
Same as current
Complete list of historical versions of study NCT00400959 on ClinicalTrials.gov Archive Site
  • perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);
  • Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D
Same as current
 
CD133+ Autologous Cells After Myocardial Infarction
Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction

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.
 
Phase I, Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Acute Myocardial Infarction
Procedure: cd133+cell intracoronary administration
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
15
October 2006
 

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.
Both
18 Years to 65 Years
No
 
Italy
 
 
NCT00400959
 
 
Fondazione Ospedale Maggiore Policlinico Milano
 
Principal Investigator: Rosaria Giordano, MD Cell Factory Department of Regenerative Medicine Policlinic Milan
Fondazione Ospedale Maggiore Policlinico Milano
November 2006

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