title: Administration of cardiac stem cells in patients with ischemic cardiomyopathy: the SCIPIO trial: surgical aspects and interim analysis of myocardial function and viability by magnetic resonance.
abstract: BACKGROUND
  SCIPIO is a first-in-human, phase 1, randomized, open-label trial of autologous c-kit(+) cardiac stem cells (CSCs) in patients with heart failure of ischemic etiology undergoing coronary artery bypass grafting (CABG). In the present study, we report the surgical aspects and interim cardiac magnetic resonance (CMR) results.
  
  
  RESULTS
  A total of 33 patients (20 CSC-treated and 13 control subjects) met final eligibility criteria and were enrolled in SCIPIO. CSCs were isolated from the right atrial appendage harvested and processed during surgery. Harvesting did not affect cardiopulmonary bypass, cross-clamp, or surgical times. In CSC-treated patients, CMR showed a marked increase in both LVEF (from 27.5 ± 1.6% to 35.1 ± 2.4% [P=0.004, n=8] and 41.2 ± 4.5% [P=0.013, n=5] at 4 and 12 months after CSC infusion, respectively) and regional EF in the CSC-infused territory. Infarct size (late gadolinium enhancement) decreased after CSC infusion (by manual delineation: -6.9 ± 1.5 g [-22.7%] at 4 months [P=0.002, n=9] and -9.8 ± 3.5 g [-30.2%] at 12 months [P=0.039, n=6]). LV nonviable mass decreased even more (-11.9 ± 2.5 g [-49.7%] at 4 months [P=0.001] and -14.7 ± 3.9 g [-58.6%] at 12 months [P=0.013]), whereas LV viable mass increased (+11.6 ± 5.1 g at 4 months after CSC infusion [P=0.055] and +31.5 ± 11.0 g at 12 months [P=0.035]).
  
  
  CONCLUSIONS
  Isolation of CSCs from cardiac tissue obtained in the operating room is feasible and does not alter practices during CABG surgery. CMR shows that CSC infusion produces a striking improvement in both global and regional LV function, a reduction in infarct size, and an increase in viable tissue that persist at least 1 year and are consistent with cardiac regeneration.
  
  
  BACKGROUND
  This study is registered with clinicaltrials.gov, trial number NCT00474461.
authors.affiliation: Division of Cardiovascular Medicine, University of Louisville, Louisville, KY, USA.
authors.forename: Atul R
authors.initials: AR
authors.lastname: Chugh
authors.forename: Garth M
authors.initials: GM
authors.lastname: Beache
authors.forename: John H
authors.initials: JH
authors.lastname: Loughran
authors.forename: Nathan
authors.initials: N
authors.lastname: Mewton
authors.forename: Julius B
authors.initials: JB
authors.lastname: Elmore
authors.forename: Jan
authors.initials: J
authors.lastname: Kajstura
authors.forename: Patroklos
authors.initials: P
authors.lastname: Pappas
authors.forename: Antone
authors.initials: A
authors.lastname: Tatooles
authors.forename: Marcus F
authors.initials: MF
authors.lastname: Stoddard
authors.forename: Joao A C
authors.initials: JA
authors.lastname: Lima
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
authors.forename: Piero
authors.initials: P
authors.lastname: Anversa
authors.forename: Roberto
authors.initials: R
authors.lastname: Bolli
mesh_terms: D020517:Atrial Appendage / Q000166:cytology; D002470:Cell Survival; D003131:Combined Modality Therapy; D001026:Coronary Artery Bypass; D005240:Feasibility Studies; D006321:Heart / Q000502:physiology; D006333:Heart Failure / Q000209:etiology / Q000601:surgery*; D006352:Heart Ventricles / Q000473:pathology; D006801:Humans; D008279:Magnetic Resonance Imaging; D009203:Myocardial Infarction / Q000150:complications / Q000473:pathology / Q000601:surgery*; D032383:Myocytes, Cardiac / Q000473:pathology; D019009:Proto-Oncogene Proteins c-kit / Q000032:analysis; D020127:Recovery of Function; D012038:Regeneration; D033581:Stem Cell Transplantation; D014182:Transplantation, Autologous; D016277:Ventricular Function, Left
chemical_list: D019009:Proto-Oncogene Proteins c-kit