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OpenTrials
Completed

NCT Number: NCT00400959

CD133+ Autologous 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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cell Factory, department of regenerative medicine, Policlinic of Milan

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cd133+cell intracoronary administration

Procedure

Primary outcomes

  1. myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),

  2. Ejection fraction (%) evaluated by 2D echocardiography;

Secondary outcomes

  1. perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);

  2. Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction

Important dates

Study start
2004
Study completion
2006
First posted
Nov 17, 2006
Registry last updated
Nov 17, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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