title: Combined delivery of bone marrow-derived mononuclear cells in chronic ischemic heart disease: rationale and study design.
abstract: BACKGROUND
  Treatment with bone marrow-derived mononuclear cells (BM-MNC) may improve left ventricular (LV) function in patients with chronic ischemic heart disease (IHD). Delivery method of the cell product may be crucial for efficacy.
  
  
  OBJECTIVE
  We aimed to demonstrate that the combination of intramyocardial and intracoronary injection of BM-MNC is safe and improves LV function in patients with chronic IHD.
  
  
  METHODS
  After a safety/feasibility phase of 10 patients, 54 patients will be randomly assigned in a 1:1:1 pattern to 1 control and 2 BM-MNC treatment groups. The control group will be treated with state-of-the-art medical management. The treatment groups will receive either exclusively intramyocardial injection or a combination of intramyocardial and intracoronary injection of autologous BM-MNC. Left ventricular function as well as scar size, transmural extension, and regional wall-motion score will be assessed by cardiac magnetic resonance imaging studies at baseline and after 6 months. The primary endpoint is the change in global LV ejection fraction by cardiac magnetic resonance from 6 months to baseline.
  
  
  RESULTS
  The results, it is hoped, will have important clinical impact and provide essential information to improve the design of future regenerative-medicine protocols in cardiology.
  
  
  CONCLUSIONS
  As cell delivery may play an important role in chronic IHD, we aim to demonstrate feasibility and efficacy of a combined cell-delivery approach in patients with decreased LV function.
authors.affiliation: Division of Cardiology, Ticino Cardiac Center Foundation, Lugano, Switzerland; Cell Therapy Unit, Ticino Cardiac Center, Lugano, Switzerland.
authors.forename: Daniel
authors.initials: D
authors.lastname: Sürder
authors.forename: Marina
authors.initials: M
authors.lastname: Radrizzani
authors.forename: Lucia
authors.initials: L
authors.lastname: Turchetto
authors.forename: Viviana Lo
authors.initials: VL
authors.lastname: Cicero
authors.forename: Sabrina
authors.initials: S
authors.lastname: Soncin
authors.forename: Stefano
authors.initials: S
authors.lastname: Muzzarelli
authors.forename: Angelo
authors.initials: A
authors.lastname: Auricchio
authors.forename: Tiziano
authors.initials: T
authors.lastname: Moccetti
mesh_terms: D016026:Bone Marrow Transplantation / Q000379:methods*; D002908:Chronic Disease; D002985:Clinical Protocols; D005240:Feasibility Studies; D006801:Humans; D007267:Injections; D007963:Leukocytes, Mononuclear / Q000637:transplantation*; D008279:Magnetic Resonance Imaging; D009200:Myocardial Contraction; D017202:Myocardial Ischemia / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D009206:Myocardium / Q000473:pathology; D020127:Recovery of Function; D012107:Research Design; D013318:Stroke Volume; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left