IMPORTANCE:
Cell therapy has been a potential approach for ST-segment elevation acute myocardial infarction (STEMI). To improve the therapeutic oucome, the safety and efficacy of hypoxia-preconditioned (H-) bone marrow mononuclear cells (BMCs) in AMI patients need further evaluation.
OBJECTIVE:
To investigate the safety and efficacy of H-BMCs therapy in AMI patients.
DESIGN:
A phase 1, randomized and blinded study (February, 2011~ March, 2012) with one-year of follow-up.
SETTING:
A single center for hospitalized care.
PARTICIPANTS:
22 Patients with an acute ST elevation myocardial infarction were recruited and randomized to two groups: normoxia BMCs (N-, n=11) and H-BMCs (n=11).
INTERVENTIONS:
Intracoronary infusion of H-BMCs or N-BMCs within 5-7 days after treatment with percutaneous transluminal coronary intervention (PCI). Patients were similarly treated by a stop-flow technique through an over-the-wire balloon catheter.
MAIN OUTCOMES AND MEASURES:
Primary endpoint was Treatment-emergent 30-day serious adverse event rate defined as a composite of death, MI, sustained ventricular tachycardia, stroke, hospitalization for worsening heart failure and revascularization. Secondary endpoints were change of myocardium perfusion, global left ventricular ejection fraction and left ventricular volumes.
RESULTS:
The primary endpoint events was none for N-BMCs and 9.1% (95% CI, 0.2%-41.3%) for H-BMCs. There was significant increase in the change of LVEF of H-BMCs group at 6 month. The change of end diastolic volume (EDV) and end systolic volume (ESV) in H-BMCs at 12 month were significantly decreased. Ratio of myocardium perfusion defect by Single-Photon Emission Computed Tomography (SPECT) was significantly reduced in H-BMCs group at 6 months, and score of myocardium perfusion defect by SPECT was significantly reduced than that of baseline in H-BMCs group at 6 and 12 months, unlike N- group.
CONCLUSIONS AND RELEVANCE:
Intracoronary infusion with H-BMCs appeared to be safe and effective for patients with AMI. Although the sample size precludes a definitive statement about safety and efficacy, these results provide the basis for larger studies to provide definitive evidence about safety and to assess efficacy of this new therapeutic approach.
Perfusion defect size predicts engraftment but not early retention of intra-myocardially injected cardiosphere-derived cells after acute myocardial infarction
