STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial

Last updated: February 2, 2021
Sponsor: Heart Care Foundation
Overall Status: Terminated

Phase

3

Condition

Hypercholesterolemia

Coronary Artery Disease

Angina

Treatment

N/A

Clinical Study ID

NCT01969890
G112
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to demonstrate that granulocyte colony-stimulating factor (G-CSF) therapy in addition to state-of-the-art treatment (pharmacological and non pharmacological) is safe and significantly improves clinical outcome in patients with reduced left ventricular ejection fraction (LVEF) (≤45%) after successful reperfusion for large anterior acute myocardial infarction.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients affected by acute anterior ST elevation myocardial infarction (STEMI)undergoing primary percutaneous coronary intervention (PCI) or PCI-rescue withpersistent occlusion of coronary artery,
  • Time symptom-to-balloon (≥3 h and ≤12h or ≤24 h if symptoms persist),
  • Thrombolysis in Myocardial Infarction (TIMI) flow post PCI ≥2,
  • Evidence of left ventricular (LV) dysfunction (EF biplane ≤45%) ≤24 h afterrevascularization,
  • Men and women aged ≥18 years and ≤75 years,
  • Informed consent must be signed before proceeding with any study procedure.

Exclusion

Exclusion Criteria:

  • Previous anterior MI,
  • Recent MI (within 1 month),
  • Known previous LV dysfunction (EF <45%),
  • Patients with angiographic evidence of coronary anatomy not suitable for PCI, orneeding coronary artery bypass grafting (CABG),
  • Valve disease requiring surgical correction,
  • History of previous cardiac surgery or PCI on LAD within 6 months,
  • Previous or current documented history of leukemia, myeloproliferative ormyelodysplastic disorder,
  • Previous or current documented history of malignant disease,
  • Haemoglobin <10 mg/dl,
  • White blood cells (WBC) >25.000 mm3,
  • Platelet <50.000 mm3,
  • Sepsis,
  • Known HIV infection,
  • Immune system diseases,
  • Interstitial lung disease
  • Serious concomitant medical conditions (other than ischemic heart disease),
  • Pregnancy and breast feeding,
  • Documented alcohol and drug abuse,
  • Anticipated poor compliance.
  • Current participation in a clinical trial with other investigational products
  • Other cell therapy.

Study Design

Total Participants: 532
Study Start date:
October 01, 2013
Estimated Completion Date:
May 31, 2018

Study Description

Post infarction heart failure (HF) remains a major cause of morbidity and mortality. In the United States, more than three million patients, and 700.000 in Italy, have cardiac failure and its most common cause is ischemic heart disease. The major goal to improve post infarction LV function would be the stimulation of neovascularization and the enhancement of regeneration of cardiac myocytes within the infarcted area. Recent experimental studies suggest that bone marrow-derived progenitor cells (BMCs) or circulating endothelial progenitor cells (cEPCs) contribute to the regeneration of infarcted myocardium, to enhance neovascularization of ischemic myocardium, to prevent cardiomyocyte apoptosis, to alter scar formation by reducing the development of myocardial fibrosis and, thereby, to improve cardiac function.

G-CSF is a hematopoietic cytokine produced by monocytes, fibroblasts and endothelial cells. G-CSF is known to have multiple functions in normal, steady-state hematopoiesis. It is routinely used to mobilize CD34+ hematopoietic stem cells from the BM into peripheral blood, thus enabling their easier collection compared to BM aspirate procedure. The proven efficacy and safety of G-CSF, both in healthy donors and patients with haematological disease, along with favourable results from studies of CD34+ cell transplantation in patients with MI or ischemia, suggest that G-CSF based BMC transplantation may have an efficacy in patients with MI.

Connect with a study center

  • Ospedali Riuniti - SOD Cardiologia Ospedaliera e UTIC

    Ancona, AN 60122
    Italy

    Site Not Available

  • Ospedale Generale Provinciale CG Mazzoni - Divisione di Cardiologia

    Ascoli Piceno, AP 63100
    Italy

    Site Not Available

  • Ospedale San Donato - UO Cardiologia

    Arezzo, AR 52100
    Italy

    Site Not Available

  • AORN Giuseppe Moscati - UO Cardiologia-UTIC

    Avellino, AV 83100
    Italy

    Site Not Available

  • Humanitas Gavazzeni - UO Cardiologia

    Bergamo, BG 24125
    Italy

    Site Not Available

  • Ospedale Bolognini - Divisione di Cardiologia

    Seriate, BG 24068
    Italy

    Site Not Available

  • Ospedali Treviglio-Caravaggio - Divisione di Cardiologia

    Treviglio, BG 24047
    Italy

    Site Not Available

  • Ospedale Maggiore - UO Cardiologia

    Bologna, BO 40133
    Italy

    Site Not Available

  • Ospedale Sant'Elia - Cardiologia-UTIC

    Caltanissetta, CL 93100
    Italy

    Site Not Available

  • Ospedale Moriggia Pelascini - UO Cardiologia

    Gravedona, CO 22015
    Italy

    Site Not Available

  • Ospedale Sant'Anna - UOC Cardiologia

    San Fermo della Battaglia, CO 22020
    Italy

    Site Not Available

  • Ospedale Maggiore - UO Cardiologia e UTIC

    Crema, CR 26013
    Italy

    Site Not Available

  • Istituti Ospitalieri - UO Cardiologia

    Cremona, CR 26100
    Italy

    Site Not Available

  • AOU Careggi - Cardiologia Generale 1

    Firenze, FI 50134
    Italy

    Site Not Available

  • IRCCS San Martino Ist. Ricerca sul Cancro - UO Cardiologia

    Genova, GE 16132
    Italy

    Site Not Available

  • Ospedale della Misericordia - UO Cardiologia

    Grosseto, GR 58100
    Italy

    Site Not Available

  • Presidio Ospedaliero - UO Cardiologia

    Sanremo, IM 18038
    Italy

    Site Not Available

  • Ospedale Alessandro Manzoni - SCD Cardiologia

    Lecco, LC 23900
    Italy

    Site Not Available

  • Ospedale Campo Marte - UO Cardiologia

    Lucca, LU 55100
    Italy

    Site Not Available

  • Ospedale di Circolo - UOC Cardiologia - UTIC

    Desio, MB 20832
    Italy

    Site Not Available

  • Ospedale San Gerardo - UO Cardiologia UTIC

    Monza, MB 20900
    Italy

    Site Not Available

  • Ospedale Bassini - UO Cardiologia e UTIC

    Cinisello Balsamo, MI 20092
    Italy

    Site Not Available

  • Ospedale Civile - UTIC - Cardiologia

    Legnano, MI 20025
    Italy

    Site Not Available

  • Centro Cardiologico Monzino - Terapia Intensiva Cardiologica UTIC

    Milano, MI 20138
    Italy

    Site Not Available

  • Ospedale Fatebenefratelli e Oftalmico - Cardiologia e UCC

    Milano, MI 20121
    Italy

    Site Not Available

  • Ospedale L. Sacco - Divisione di Cardiologia

    Milano, MI 20157
    Italy

    Site Not Available

  • Ospedale Maggiore Policlinico - Divisione di Cardiologia

    Milano, MI 20122
    Italy

    Site Not Available

  • Ospedale Niguarda - Cardiologia 1 - Emodinamica

    Milano, MI 20162
    Italy

    Site Not Available

  • Ospedale San Carlo Borromeo - Cardiologia UCC

    Milano, MI 20153
    Italy

    Site Not Available

  • Ospedale San Luca - Centro Auxologico - UO Cardiologia

    Milano, MI 20149
    Italy

    Site Not Available

  • Ospedale San Paolo - Divisione di Cardiologia

    Milano, MI 20142
    Italy

    Site Not Available

  • Istituto Clinico Humanitas - UO Cardiologia Interventistica e UTIC

    Rozzano, MI 20089
    Italy

    Site Not Available

  • Presidio Ospedaliero Carlo Poma - UO Cardiologia

    Mantova, MN 46100
    Italy

    Site Not Available

  • Ospedale San Francesco - Cardiologia UTIC

    Nuoro, NU 08100
    Italy

    Site Not Available

  • Ospedale Giovanni Paolo II - UTIC Cardiologia

    Olbia, OT 07026
    Italy

    Site Not Available

  • Ospedale Civile "Guglielmo da Saliceto" - Divisione di Cardiologia

    Piacenza, PC 29100
    Italy

    Site Not Available

  • Azienda Ospedaliera Padova - Clinica Cardiologica

    Padova, PD 35128
    Italy

    Site Not Available

  • AOU Pisana - UO Malattie Cardiovasc. 1-Cisanello

    Pisa, PI 56124
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo - Card. con UCC-Lab. Ricerca Sperim. Card.

    Pavia, PV 27100
    Italy

    Site Not Available

  • Arcispedale Santa Maria Nuova - UO Degenza Cardiologica

    Reggio Emilia, RE 42100
    Italy

    Site Not Available

  • AO San Giovanni Addolorata - Cardiologia 2

    Roma, RM 00184
    Italy

    Site Not Available

  • Ospedale Infermi - UO Cardiologia

    Rimini, RN 47900
    Italy

    Site Not Available

  • AOUS Giovanni Di Dio Ruggi D'Aragona - UOC UTIC

    Salerno, SA 84131
    Italy

    Site Not Available

  • AOU San Giovanni Battista - SCDU Cardiologia 1

    Torino, TO 10126
    Italy

    Site Not Available

  • AOU Ospedali Riuniti - SOC Cardiologia - Ospedale Cattinara

    Trieste, TS 34149
    Italy

    Site Not Available

  • Ospedale Ca' Foncello - UOC Cardiologia

    Treviso, TV 31100
    Italy

    Site Not Available

  • Ospedale di Circolo di Busto Arsizio - Divisione di Cardiologia

    Busto Arsizio, VA 21052
    Italy

    Site Not Available

  • Ospedale Sant'Antonio Abate - UO Cardiologia

    Gallarate, VA 21013
    Italy

    Site Not Available

  • Presidio Ospedaliero di Saronno - UOC Cardiologia

    Saronno, VA 21047
    Italy

    Site Not Available

  • Ospedale di Circolo Fondazione Macchi - SSD Unità di Cure Intensive Coronariche

    Varese, VA 21100
    Italy

    Site Not Available

  • Ospedale dell'Angelo - UO Cardiologia

    Mestre, VE 30174
    Italy

    Site Not Available

  • Ospedale Belcolle - UOC Cardiologia UTIC Emodinamica

    Viterbo, VT 01100
    Italy

    Site Not Available

  • AORN Cardarelli - UO SC Cardiologia con UTIC

    Napoli, 80131
    Italy

    Site Not Available

  • AOU Federico II - UTIC

    Napoli, 80131
    Italy

    Site Not Available

  • AO Univ. Maggiore della Carità - Cardiologia 2

    Novara, 28100
    Italy

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.