STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial

• Status: Terminated
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heart Care Foundation
• Collaborators: A. Manzoni Hospital; Centro Cardiologico Monzino

Criteria

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.