The Impact of Repeated Intracoronary Injection of Autologous Bone-marrow Derived Mononuclear Cells for Left Ventricle Contractility and Remodeling in Patients With STEMI.Prospective Randomized Study.

The study is divided into 3 parts:

• Screening phase: Patients will be recruited at the investigational clinical centers. Alternatively, patients who had primary PCI performed at institutions different from the investigational sites can also be enrolled. Interested patients may be referred for screening to any of the participating study sites after acute reperfusion therapy. Informed consent and assessment of eligibility of patients with respect to in- and exclusion criteria will be done at the investigational site. If all other eligibility criteria are met, echocardiography will be performed 3 to 6 days after the acute PCI, and ejection fraction will be quantified by a central Echo Core Lab after web based transmission. CT examination will be performed 1 month after acute PCI in all screened patients with LVEF ≤ 45%. If LVEF will not improve ≥5% in the CT the patient may be qualified into the Study.
• Treatment phase: Bone marrow aspiration will be performed for the patients assigned to the treatment group (II). Bone marrow will be collected from the patient and MNC isolated using point-of-care system (Harvest) at a Site. Intracoronary infusion of BM-MNCs will be performed up to 2 hours after isolation via radial approach. Same procedure will be performed 3 and 6 months after first application.
• Follow-up phase: After hospital discharge, patients will be followed up per telephone 30 days and 3, 6, 9 months after randomisation and with a site visit with CT examination 12 months after randomisation. Afterwards, telephone follow up will be performed every 3 months. Once the required number of clinical events has been observed, all patients will attend a final study visit, but minimum follow up period for each patient is 2 years. Endpoints will be reported as occurring throughout the follow up.