title: [Observation on the safety: clinical trail on intracoronary autologous bone marrow mononuclear cells transplantation for acute myocardial infarction].
abstract: OBJECTIVE
  To investigate the safety of autologous bone marrow mononuclear cell (BM-MNCs) transplantation by intracoronary infusion in patients with acute myocardial infarction (AMI).
  
  
  METHODS
  One hundred and eighty-four patients with AMI treated with percutaneous coronary intervention (PCI) were randomized in a 1:1 way to either intracoronary transplantation of autologous BM-MNCs (n = 92) right after PCI or to sodium chloride concluding heparin (controlled, n = 92) via a micro infusion catheter. In the process of the intracoronary infusion of BM-MNCs, the complications should be recorded, which were aberration reflect (including of pale, syncope, nausea, hypotension and shock), deterioration of angina or heart failure, arrhythmias (including of bradycardia, sinus arrest or atrial ventricular block or ventricular fibrillation), embolism etc. Body temperature, blood pressure and heart rates should be monitored during the first week after transplantation. Holter, coronary angiography and ultrasonic cardiography were performed at the designed time points. Main heart accidents, restenosis and tumor were recorded during 2-years follow up.
  
  
  RESULTS
  During the period of bone marrow puncture and intracoronary infusion of BM-MNCs, few patients occurred pale, dizziness, bradycardia and hypotension, which were transient and due to vagus reflect. No stem cell-related arrhythmias, deterioration of angina were noted. In BM-MNCs group one patient developed in-stent reocclusion in one week after transplantation, five developed in-stent restenosis during further follow-up 30 months, which were similar with control group. There were no deaths, major adverse cardiac events, tumor and other late adverse events during follow-up period in both groups.
  
  
  CONCLUSIONS
  Intracoronary transplantation of autologous BM-MNCs in the acute phase after AMI is feasible and seems safe in the 30 months of follow-up.
authors.affiliation: Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai 200032, China.
authors.forename: Kang
authors.initials: K
authors.lastname: Yao
authors.forename: Rong-chong
authors.initials: RC
authors.lastname: Huang
authors.forename: Lei
authors.initials: L
authors.lastname: Ge
authors.forename: Ju-ying
authors.initials: JY
authors.lastname: Qian
authors.forename: Yan-lin
authors.initials: YL
authors.lastname: Li
authors.forename: Shi-kun
authors.initials: SK
authors.lastname: Xu
authors.forename: Feng
authors.initials: F
authors.lastname: Zhang
authors.forename: Yi-qi
authors.initials: YQ
authors.lastname: Zhang
authors.forename: Yu-hong
authors.initials: YH
authors.lastname: Niu
authors.forename: Jian-hui
authors.initials: JH
authors.lastname: Shi
authors.forename: Shao-heng
authors.initials: SH
authors.lastname: Zhang
authors.forename: Bing
authors.initials: B
authors.lastname: Fan
authors.forename: Qi-bing
authors.initials: QB
authors.lastname: Wang
authors.forename: Ai-jun
authors.initials: AJ
authors.lastname: Sun
authors.forename: Yun-zeng
authors.initials: YZ
authors.lastname: Zou
authors.forename: Jun-bo
authors.initials: JB
authors.lastname: Ge
mesh_terms: D000328:Adult; D000368:Aged; D016026:Bone Marrow Transplantation / Q000379:methods*; D003331:Coronary Vessels; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods; D008875:Middle Aged; D009203:Myocardial Infarction / Q000601:surgery*; D014182:Transplantation, Autologous