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

Atul R. Chugh, Garth M. Beache, John H. Loughran, Nathan Mewton, Julius B. Elmore, Jan Kajstura, Patroklos Pappas, Antone Tatooles, Marcus F. Stoddard, Joao A.C. Lima, Mark S. Slaughter, Piero Anversa, Roberto Bolli

Research output: Contribution to journalArticle

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. Methods and 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. CLINICAL TRIAL REGISTRATION-: This study is registered with clinicaltrials.gov, trial number NCT00474461.

Original languageEnglish (US)
Pages (from-to)S54-S64
JournalCirculation
Volume126
Issue number11 SUPPL.1
DOIs
StatePublished - Sep 11 2012

Keywords

  • MRI
  • coronary artery bypass
  • heart failure
  • infarction
  • regeneration
  • stem cells

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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    Chugh, A. R., Beache, G. M., Loughran, J. H., Mewton, N., Elmore, J. B., Kajstura, J., Pappas, P., Tatooles, A., Stoddard, M. F., Lima, J. A. C., Slaughter, M. S., Anversa, P., & Bolli, R. (2012). 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. Circulation, 126(11 SUPPL.1), S54-S64. https://doi.org/10.1161/CIRCULATIONAHA.112.092627