title: Isolated coronary artery bypass graft combined with bone marrow mononuclear cells delivered through a graft vessel for patients with previous myocardial infarction and chronic heart failure: a single-center, randomized, double-blind, placebo-controlled clinical trial.
abstract: OBJECTIVE
  This study aimed at examining the efficacy of bone marrow mononuclear cell (BMMNC) delivery through graft vessel for patients with a previous myocardial infarction (MI) and chronic heart failure during coronary artery bypass graft (CABG).
  
  
  BACKGROUND
  Little evidence exists supporting the practice of BMMNC delivery through graft vessel for patients with a previous MI and chronic heart failure during CABG.
  
  
  METHODS
  From November 2006 to June 2009, a randomized, placebo-controlled trial was conducted to test the efficacy and safety of CABG for multivessel coronary artery disease combined with autologous BMMNCs in patients with congestive heart failure due to severe ischemic cardiomyopathy. Sixty-five patients were recruited, and 60 patients remained in the final trial and were randomized to a CABG + BMMNC group (n = 31) and a placebo-control group (i.e., CABG-only group, n = 29). All patients discharged received a 6-month follow-up. Changes in left ventricular ejection fraction from baseline to 6-month follow-up, as examined by magnetic resonance imaging, were of primary interest.
  
  
  RESULTS
  The overall baseline age was 59.5 ± 9.2 years, and 6.7% were women. After a 6-month follow-up, compared with the placebo-control group, the CABG + BMMNC group had significant changes in left ventricular ejection fraction (p = 0.029), left ventricular end-systolic volume index (p = 0.017), and wall motion index score (p = 0.011). Also, the changes in the distance on the 6-min walking test as well as B-type natriuretic peptide were significantly greater in the CABG + BMMNC group than in the control group.
  
  
  CONCLUSIONS
  In summary, patients with a previous MI and chronic heart failure could potentially benefit from isolated CABG (i.e., those who received CABG only) combined with BMMNCs delivered through a graft vessel. (Stem Cell Therapy to Improve Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting [CABG]; NCT00395811).
authors.affiliation: Department of Cardiovascular Surgery, Fuwai Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China. shengshouhu@yahoo.com
authors.forename: Shengshou
authors.initials: S
authors.lastname: Hu
authors.forename: Sheng
authors.initials: S
authors.lastname: Liu
authors.forename: Zhe
authors.initials: Z
authors.lastname: Zheng
authors.forename: Xin
authors.initials: X
authors.lastname: Yuan
authors.forename: Lihuan
authors.initials: L
authors.lastname: Li
authors.forename: Minjie
authors.initials: M
authors.lastname: Lu
authors.forename: Rui
authors.initials: R
authors.lastname: Shen
authors.forename: Fujian
authors.initials: F
authors.lastname: Duan
authors.forename: Xiaoling
authors.initials: X
authors.lastname: Zhang
authors.forename: Jun
authors.initials: J
authors.lastname: Li
authors.forename: Xuewen
authors.initials: X
authors.lastname: Liu
authors.forename: Yunhu
authors.initials: Y
authors.lastname: Song
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.forename: Shihua
authors.initials: S
authors.lastname: Zhao
authors.forename: Zuoxiang
authors.initials: Z
authors.lastname: He
authors.forename: Hao
authors.initials: H
authors.lastname: Zhang
authors.forename: Keming
authors.initials: K
authors.lastname: Yang
authors.forename: Wei
authors.initials: W
authors.lastname: Feng
authors.forename: Xin
authors.initials: X
authors.lastname: Wang
mesh_terms: D000368:Aged; D016026:Bone Marrow Transplantation / Q000379:methods*; D016009:Chi-Square Distribution; D002681:China; D003131:Combined Modality Therapy; D001026:Coronary Artery Bypass / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection; D006085:Graft Survival; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000628:therapy; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D008297:Male; D008875:Middle Aged; D016343:Monitoring, Intraoperative / Q000379:methods; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D020257:Ventricular Remodeling / Q000502:physiology