title: Rationale and design of the first randomized, double-blind, placebo-controlled trial of intramyocardial injection of autologous bone-marrow derived Mesenchymal Stromal Cells in chronic ischemic Heart Failure (MSC-HF Trial).
abstract: BACKGROUND
  Stem cell therapy is an emerging treatment modality in cardiovascular disease. The best cell type and delivery method in different cardiovascular diseases remain to be determined.
  
  
  METHODS
  The MSC-HF trial is a phase 2, single-center, double-blind, randomized, placebo-controlled trial of intramyocardial delivery of autologous bone-marrow derived mesenchymal stromal cells (MSCs) in patients with chronic ischemic heart failure. A total of 60 patients will be randomized in a 2:1 pattern to receive intramyocardial injections of either MSCs or placebo. Patients will be followed up for 12 months.
  
  
  METHODS
  Bone marrow will be obtained by aspiration from the iliac crest. Mesenchymal stromal cells will be isolated, and culture will be expanded for 6 to 8 weeks. A total of 12 to 15 MSC or placebo injections will be placed in an ischemic viable region of the myocardium using the electromechanical NOGA-XP system (Biologics Delivery Systems Group, Johnson & Johnson, Irwindale, CA).
  
  
  METHODS
  The primary endpoint is change in left ventricle end-systolic volume, measured by magnetic resonance imaging (MRI) or computed tomography (CT) at 6-month follow-up. Secondary endpoints are left ventricle ejection fraction, ventricular volumes, wall thickness, and systolic wall thickening measured by MRI or CT in addition to measurement of myocardial scar tissue by MRI. Other secondary endpoints are safety of treatment, clinical symptoms and functional capacity, weekly angina attacks, use of short-term nitroglycerine, and quality of life.
  
  
  CONCLUSIONS
  A randomized, double-blind, placebo-controlled, clinical trial of intramyocardial delivery of MSCs in patients with ischemic heart failure has been set up to confirm the positive findings in open-labeled clinical trials.
authors.affiliation: Cardiac Stem Cell Laboratory and Catheterization Laboratory, Rigshospitalet, Copenhagen University Hospital, Denmark. abbe@dadlnet.dk
authors.forename: Anders Bruun
authors.initials: AB
authors.lastname: Mathiasen
authors.forename: Erik
authors.initials: E
authors.lastname: Jørgensen
authors.forename: Abbas Ali
authors.initials: AA
authors.lastname: Qayyum
authors.forename: Mandana
authors.initials: M
authors.lastname: Haack-Sørensen
authors.forename: Annette
authors.initials: A
authors.lastname: Ekblond
authors.forename: Jens
authors.initials: J
authors.lastname: Kastrup
mesh_terms: D001854:Bone Marrow Cells; D003324:Coronary Artery Disease / Q000503:physiopathology / Q000628:therapy*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D007267:Injections; D008279:Magnetic Resonance Imaging; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods*; D012107:Research Design; D013318:Stroke Volume; D013599:Systole; D014057:Tomography, X-Ray Computed; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000502:physiology