title: A critical challenge: dosage-related efficacy and acute complication intracoronary injection of autologous bone marrow mesenchymal stem cells in acute myocardial infarction.
abstract: BACKGROUND
  Previous studies showed improvement in heart function by injecting bone marrow mesenchymal stem cells (BMSCs) after AMI. Emerging evidence suggested that both the number and function of BMSCs decline with ageing. We designed a randomized, controlled trial to further investigate the safety and efficacy of this treatment.
  
  
  METHODS
  Patients with ST-elevation AMI undergoing successful reperfusion treatment within 12 hours were randomly assigned to receive an intracoronary infusion of BMSCs (n=21) or standard medical treatment (n=22) (the numbers of patients were limited because of the complication of coronary artery obstruction).
  
  
  RESULTS
  There is a closely positive correlation of the number and function of BMSCs vs. the cardiac function reflected by LVEF at baseline (r=0.679, P=0.001) and at 12-month follow-up (r=0.477, P=0.039). Six months after cell administration, myocardial viability within the infarct area by 18-FDG SPECT was improved in both groups compared with baseline, but no significant difference in the BMSCs compared with control groups (4.0±0.4% 95%CI 3.1-4.9 vs. 3.2±0.5% 95%CI 2.1-4.3, P=0.237). 99mTc-sestamibi SPECT demonstrated that myocardial perfusion within the infarct area in the BMSCs did not differ from the control group (4.4±0.5% 95%CI 3.2-5.5 vs. 3.9±0.6% 95%CI 2.6-5.2, P=0.594). Similarly, LVEF after 12 and 24 months follow-up did not show any difference between the two groups. In the BMSCs group, one patient suffered a serious complication of coronary artery occlusion during the BMSCs injection procedure.
  
  
  CONCLUSIONS
  The clinical benefits of intracoronary injection of autologous BMSCs in acute STEMI patients need further investigation and reevaluation.
authors: Center of Cardiology, Navy General Hospital, Beijing, China. Electronic address: lianru@yahoo.com.cn.
authors: Lian R
authors: LR
authors: Gao
authors: Xue T
authors: XT
authors: Pei
authors: Qing A
authors: QA
authors: Ding
authors: Yu
authors: Y
authors: Chen
authors: Ning K
authors: NK
authors: Zhang
authors: Hai Y
authors: HY
authors: Chen
authors: Zhi G
authors: ZG
authors: Wang
authors: Yun F
authors: YF
authors: Wang
authors: Zhi M
authors: ZM
authors: Zhu
authors: Tian C
authors: TC
authors: Li
authors: Hui L
authors: HL
authors: Liu
authors: Zi C
authors: ZC
authors: Tong
authors: Yong
authors: Y
authors: Yang
authors: Xue
authors: X
authors: Nan
authors: Feng
authors: F
authors: Guo
authors: Jian L
authors: JL
authors: Shen
authors: Yan H
authors: YH
authors: Shen
authors: Jian J
authors: JJ
authors: Zhang
authors: Yu X
authors: YX
authors: Fei
authors: Hong T
authors: HT
authors: Xu
authors: Li H
authors: LH
authors: Wang
authors: Hai T
authors: HT
authors: Tian
authors: Da Q
authors: DQ
authors: Liu
authors: Ye
authors: Y
authors: Yang
mesh_terms: D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007269:Injections, Intra-Arterial; D007431:Intraoperative Complications / Q000000981:diagnostic imaging*; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging* / Q000601:surgery*; D011877:Radionuclide Imaging; D016037:Single-Blind Method; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome
keywords: Acute myocardial infarction; Bone marrow mesenchymal stem cells; Intracoronary injection