STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial (STEM-AMI)

February 2, 2021 updated by: Heart Care Foundation

Phase III Study on STem cElls Mobilization in Acute Myocardial Infarction

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

532

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • AORN Cardarelli - UO SC Cardiologia con UTIC
      • Napoli, Italy, 80131
        • AOU Federico II - UTIC
      • Novara, Italy, 28100
        • AO Univ. Maggiore della Carità - Cardiologia 2
    • AN
      • Ancona, AN, Italy, 60122
        • Ospedali Riuniti - Sod Cardiologia Ospedaliera E Utic
    • AP
      • Ascoli Piceno, AP, Italy, 63100
        • Ospedale Generale Provinciale CG Mazzoni - Divisione di Cardiologia
    • AR
      • Arezzo, AR, Italy, 52100
        • Ospedale San Donato - UO Cardiologia
    • AV
      • Avellino, AV, Italy, 83100
        • AORN Giuseppe Moscati - UO Cardiologia-UTIC
    • BG
      • Bergamo, BG, Italy, 24125
        • Humanitas Gavazzeni - UO Cardiologia
      • Seriate, BG, Italy, 24068
        • Ospedale Bolognini - Divisione di Cardiologia
    • BO
      • Bologna, BO, Italy, 40133
        • Ospedale Maggiore - UO Cardiologia
    • CL
      • Caltanissetta, CL, Italy, 93100
        • Ospedale Sant'Elia - Cardiologia-UTIC
    • CO
      • Gravedona, CO, Italy, 22015
        • Ospedale Moriggia Pelascini - UO Cardiologia
      • San Fermo della Battaglia, CO, Italy, 22020
        • Ospedale Sant'Anna - UOC Cardiologia
    • CR
      • Crema, CR, Italy, 26013
        • Ospedale Maggiore - UO Cardiologia e UTIC
      • Cremona, CR, Italy, 26100
        • Istituti Ospitalieri - UO Cardiologia
    • FI
      • Firenze, FI, Italy, 50134
        • AOU Careggi - Cardiologia Generale 1
    • GE
      • Genova, GE, Italy, 16132
        • IRCCS San Martino Ist. Ricerca sul Cancro - UO Cardiologia
    • GR
      • Grosseto, GR, Italy, 58100
        • Ospedale della Misericordia - UO Cardiologia
    • IM
      • Sanremo, IM, Italy, 18038
        • PRESIDIO OSPEDALIERO - UO Cardiologia
    • LC
      • Lecco, LC, Italy, 23900
        • Ospedale Alessandro Manzoni - SCD Cardiologia
    • LU
      • Lucca, LU, Italy, 55100
        • Ospedale Campo Marte - UO Cardiologia
    • MB
      • Desio, MB, Italy, 20832
        • Ospedale di Circolo - UOC Cardiologia - UTIC
      • Monza, MB, Italy, 20900
        • Ospedale San Gerardo - UO Cardiologia UTIC
    • MI
      • Cinisello Balsamo, MI, Italy, 20092
        • Ospedale Bassini - UO Cardiologia e UTIC
      • Legnano, MI, Italy, 20025
        • Ospedale Civile - UTIC - Cardiologia
      • Milano, MI, Italy, 20121
        • Ospedale Fatebenefratelli e Oftalmico - Cardiologia e UCC
      • Milano, MI, Italy, 20138
        • Centro Cardiologico Monzino - Terapia Intensiva Cardiologica UTIC
      • Milano, MI, Italy, 20122
        • Ospedale Maggiore Policlinico - Divisione di Cardiologia
      • Milano, MI, Italy, 20142
        • Ospedale San Paolo - Divisione di Cardiologia
      • Milano, MI, Italy, 20149
        • Ospedale San Luca - Centro Auxologico - UO Cardiologia
      • Milano, MI, Italy, 20153
        • Ospedale San Carlo Borromeo - Cardiologia UCC
      • Milano, MI, Italy, 20157
        • Ospedale L. Sacco - Divisione di Cardiologia
      • Milano, MI, Italy, 20162
        • Ospedale Niguarda - Cardiologia 1 - Emodinamica
      • Rozzano, MI, Italy, 20089
        • Istituto Clinico Humanitas - UO Cardiologia Interventistica e UTIC
    • MN
      • Mantova, MN, Italy, 46100
        • Presidio Ospedaliero Carlo Poma - UO Cardiologia
    • NU
      • Nuoro, NU, Italy, 08100
        • Ospedale San Francesco - Cardiologia UTIC
    • OT
      • Olbia, OT, Italy, 07026
        • Ospedale Giovanni Paolo II - UTIC Cardiologia
    • PC
      • Piacenza, PC, Italy, 29100
        • Ospedale Civile "Guglielmo da Saliceto" - Divisione di Cardiologia
    • PD
      • Padova, PD, Italy, 35128
        • Azienda Ospedaliera Padova - Clinica Cardiologica
    • PI
      • Pisa, PI, Italy, 56124
        • AOU Pisana - UO Malattie Cardiovasc. 1-Cisanello
    • PV
      • Pavia, PV, Italy, 27100
        • Fondazione Irccs Policlinico San Matteo - Card. Con Ucc-Lab. Ricerca Sperim. Card.
    • RE
      • Reggio Emilia, RE, Italy, 42100
        • Arcispedale Santa Maria Nuova - UO Degenza Cardiologica
    • RM
      • Roma, RM, Italy, 00184
        • AO San Giovanni Addolorata - Cardiologia 2
    • RN
      • Rimini, RN, Italy, 47900
        • Ospedale Infermi - UO Cardiologia
    • SA
      • Salerno, SA, Italy, 84131
        • AOUS Giovanni Di Dio Ruggi D'Aragona - UOC UTIC
    • TO
      • Torino, TO, Italy, 10126
        • AOU San Giovanni Battista - SCDU Cardiologia 1
    • TS
      • Trieste, TS, Italy, 34149
        • AOU Ospedali Riuniti - SOC Cardiologia - Ospedale Cattinara
    • TV
      • Treviso, TV, Italy, 31100
        • OSPEDALE CA' FONCELLO - UOC Cardiologia
    • VA
      • Busto Arsizio, VA, Italy, 21052
        • Ospedale di Circolo di Busto Arsizio - Divisione di Cardiologia
      • Saronno, VA, Italy, 21047
        • Presidio Ospedaliero di Saronno - UOC Cardiologia
      • Varese, VA, Italy, 21100
        • Ospedale di Circolo Fondazione Macchi - SSD Unità di Cure Intensive Coronariche
    • VE
      • Mestre, VE, Italy, 30174
        • Ospedale dell'Angelo - UO Cardiologia
    • VT
      • Viterbo, VT, Italy, 01100
        • Ospedale Belcolle - UOC Cardiologia UTIC Emodinamica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients affected by acute anterior ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) or PCI-rescue with persistent 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 after revascularization,
  • Men and women aged ≥18 years and ≤75 years,
  • Informed consent must be signed before proceeding with any study procedure.

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, or needing 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 or myelodysplastic 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G-CSF administration
Granulocyte Colony-Stimulating Factor (G-CSF) administration - 5 microg/kg subcutaneous every 12 hours for 6 days
Drug: G-CSF administration
Zarzio - 5 microg/kg bis in die for 6 days
Other Names:
  • Zarzio
No Intervention: standard therapy
Standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The composite endpoint of: - All cause death or, - recurrence of myocardial infarction (MI) or, - hospitalization due to heart failure.
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- All cause death and cardiovascular events
Time Frame: two years

The following Cardiovascular events will be assessed:

  • recurrence of MI,
  • hospitalization due to heart failure,
  • cardiovascular death,
  • coronary revascularization,
  • fatal and non fatal stroke,
  • hospitalization due to any cause,
  • cardiovascular hospitalization,
  • resuscitation and/or appropriate automated implanted cardioverter defibrillator(AICD) therapy.
two years

Other Outcome Measures

Outcome Measure
Time Frame
Safety endpoints - Incidence and severity of bleeding complications, - incidence of malignancy, - incidence and intensity of serious adverse events (SAEs) and adverse drug reactions (ADRs)
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Care Foundation

Collaborators

A. Manzoni Hospital
Centro Cardiologico Monzino

Investigators

  • Study Chair: Felice Achilli, MD, Ospedale Alessandro Manzoni - Lecco
  • Study Chair: Giulio Pompilio, MD, Centro Cardiologico Monzino - Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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