title: The safety and feasibility of the local implantation of autologous bone marrow cells for ischemic heart disease.
abstract: OBJECTIVE
  Local autologous bone marrow cell implantation (BMCI) can induce therapeutic angiogenesis. We evaluated the safety and feasibility of this treatment for ischemic heart disease.
  
  
  METHODS
  The safety of BMCI was preclinically confirmed in dogs by giving a direct injection of either 2 x 10(7) bone marrow cells (n = 4) suspended in 0.1 mL phosphate-buffered saline (PBS), or 0.1 ml PBS only (n = 4, PBS group), into the myocardium of the left ventricle at six points. Electrocardiograph (ECG), echocardiography, and systemic biochemistry indexes were recorded 1, 7, 30, and 240 days after treatment, and histological change was examined 240 days after treatment. We also evaluated the clinical safety and feasibility of BMCI in six patients with ischemic heart disease, who were given BMCI treatment in combination with coronary artery bypass grafting (CABG), by recording Holter ECG, echocardiography, computed tomography, and systemic biochemistry indexes in the acute and chronic phases after treatment.
  
  
  RESULTS
  No significant changes in systemic biochemistry indexes were found after BMCI treatment in comparison with control groups, in either the experimental investigation or the clinical trial. No cardiac damage related to BMCI was detected by ECG or echocardiography, and histological examination showed minimal fibrotic change within the myocardium after BMCI or PBS injection in the dogs. Local calcification was not detected on histological slices 240 days after treatment in the dogs, or on computed tomography 1 year after treatment in the patients.
  
  
  CONCLUSIONS
  BMCI treatment appears to be a safe and feasible method of inducing angiogenesis to treat ischemic heart disease
authors.affiliation: Department of Medical Bioregulation, Division of Cardiovascular Surgery, Yamaguchi University School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, Japan 755-8505.
authors.forename: Tao-Sheng
authors.initials: TS
authors.lastname: Li
authors.forename: Kimikazu
authors.initials: K
authors.lastname: Hamano
authors.forename: Ken
authors.initials: K
authors.lastname: Hirata
authors.forename: Toshiro
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Masahiko
authors.initials: M
authors.lastname: Nishida
mesh_terms: D000818:Animals; D016026:Bone Marrow Transplantation; D003131:Combined Modality Therapy; D001026:Coronary Artery Bypass; D003326:Coronary Circulation; D004285:Dogs; D004452:Echocardiography; D004562:Electrocardiography; D005240:Feasibility Studies; D006321:Heart / Q000000981:diagnostic imaging; D006801:Humans; D007267:Injections; D017202:Myocardial Ischemia / Q000601:surgery*; D018919:Neovascularization, Physiologic; D011859:Radiography; D014182:Transplantation, Autologous