Clinical trial NCT00400959: CD133+ Autologous Cells After Myocardial Infarction
Official title: Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Myocardial Infarction
Keywords: cell therapy
acute myocardial infarction
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2006-11-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


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.

Primary outcomes:
measure: myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),
measure: Ejection fraction (%) evaluated by 2D echocardiography;
Secondary outcomes:
measure: perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);
measure: Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Cell Factory, department of regenerative medicine, Policlinic of Milan
Study officials:
affiliation: Cell Factory Department of Regenerative Medicine Policlinic Milan
name: Rosaria Giordano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colombo A, Castellani M, Piccaluga E, Pusineri E, Palatresi S, Longari V, Canzi C, Sacchi E, Rossi E, Rech R, Gerundini P, Viecca M, Deliliers GL, Rebulla P, Soligo D, Giordano R. Myocardial blood flow and infarct size after CD133+ cell injection in large myocardial infarction with good recanalization and poor reperfusion: results from a randomized controlled trial. J Cardiovasc Med (Hagerstown). 2011 Apr;12(4):239-48. doi: 10.2459/JCM.0b013e328343d708.