近期前壁心肌梗死患者冠状动脉内输注外周血干细胞联合粒细胞集落刺激因子和促红细胞生成素的干细胞治疗的安全性和可行性：一项1期研究的一年随访

Safety and feasibility of combined granulocyte colony stimulating factor and erythropoetin based-stem cell therapy using intracoronary infusion of peripheral blood stem cells in patients with recent anterior myocardial infarction: one-year follow-up of a phase 1 study.

作者信息

Santoso Teguh, Irawan Cosphiadi, Alwi Idrus, Aziz Auda, Kosasih Agus, Inggriani Sri, Saputra Ardian, Wintery Merry, Lison Linda

机构信息

Department of Internal Medicine, University of Indonesia, Faculty of Medicine-Dr. Cipto Mangunkusumo Hospital. Jl. Diponegoro no. 71, Jakarta, Indonesia.

出版信息

Acta Med Indones. 2011 Apr;43(2):112-21.

PMID:21785174

Abstract

AIM

to assess the safety and feasibility of combined granulocyte colony-stimulating factor (G-CSF) and erythropoietin (EPO) based intracoronary peripheral blood stem cells (PBSCs) therapy in patients with recent myocardial infarction (RMI) who had successful reperfusion therapy with drug-eluting stent.

METHODS

a total of 18 patients diagnosed with anterior ST-segment elevation AMI who had successful percutaneous coronary intervention (PCI) with drug-eluting stent implantation within 15 days after onset of symptom were enrolled. PBSCs were harvested and injected into the infarct-related artery after 5 consecutive days of G-CSF administration. Recombinant human erythropoietin was administered at the time of intracoronary PBSCs injection.

RESULTS

there were no procedural and periprocedural complications, such as ventricular arrhythmia, visible thrombus formation, distal embolization, injury of the coronary artery associated with the cell infusion catheterization procedure or elevation of CK-MB of more than two-times. After PBSCs injection, all patients had grade III myocardial blush grade. At follow-up of 21.1±5.5 months (range 12 to 30 months) there was no death, no re-infarction, no target lesion revascularization nor re-hospitalization for heart failure. Paired cardiac MRI demonstrated no change in left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) at 3 months, but they increased significantly at one year. Despite this, left ventricular ejection fraction (LVEF), wall motion score index (WMSI) and perfusion score index (PSI) improved at 3 months and remained stable at one year. The percentage of late gadolinium enhancement to LV mass (%LGE) were continuously improved until one year. There was no correlation between the level of CD34+, CD 45+, other cell subtypes as well as total number of PBSCs injected to the changes of LVEDV, LVESV, LVEF, WMSI, PSI, and %LGE (p >0.05).

CONCLUSION

combined G-CSF and EPO based- intracoronary infusion of PBSCs in patients RAMI is safe and feasible.

摘要

目的

评估在近期心肌梗死（RMI）且药物洗脱支架再灌注治疗成功的患者中，基于粒细胞集落刺激因子（G-CSF）和促红细胞生成素（EPO）联合应用的冠状动脉内外周血干细胞（PBSCs）治疗的安全性和可行性。

方法

共纳入18例诊断为前壁ST段抬高型急性心肌梗死且在症状发作后15天内成功进行经皮冠状动脉介入治疗（PCI）并植入药物洗脱支架的患者。在连续5天给予G-CSF后采集PBSCs并注入梗死相关动脉。在冠状动脉内注入PBSCs时给予重组人促红细胞生成素。

结果

未出现手术及围手术期并发症，如室性心律失常、可见血栓形成、远端栓塞、与细胞输注导管操作相关的冠状动脉损伤或CK-MB升高超过两倍。注入PBSCs后，所有患者心肌 blush分级均为III级。在21.1±5.5个月（范围12至30个月）的随访中，无死亡、无再梗死、无靶病变血管重建及因心力衰竭再次住院情况。配对心脏磁共振成像显示3个月时左心室舒张末期容积（LVEDV）和左心室收缩末期容积（LVESV）无变化，但1年时显著增加。尽管如此，左心室射血分数（LVEF）、壁运动评分指数（WMSI）和灌注评分指数（PSI）在3个月时改善并在1年时保持稳定。钆延迟增强占左心室心肌质量的百分比（%LGE）直至1年持续改善。注入的PBSCs中CD34 +、CD45 +、其他细胞亚型水平以及总数与LVEDV、LVESV、LVEF、WMSI、PSI和%LGE的变化之间无相关性（p>0.05）。