Pilar Jimenez-Quevedo1, Juan Jose Gonzalez-Ferrer2, Manel Sabate2, Xavier Garcia-Moll2, Roberto Delgado-Bolton2, Leopoldo Llorente2, Esther Bernardo2, Aranzazu Ortega-Pozzi2, Rosana Hernandez-Antolin2, Fernando Alfonso2, Nieves Gonzalo2, Javier Escaned2, Camino Bañuelos2, Ander Regueiro2, Pedro Marin2, Antonio Fernandez-Ortiz2, Barbara Das Neves2, Maria Del Trigo2, Cristina Fernandez2, Teresa Tejerina2, Santiago Redondo2, Eulogio Garcia2, Carlos Macaya2. 1. From the Cardiology and Hematology Department, Hospital Clínico San Carlos, IdISSC, Madrid, Spain (P.J.-Q., J.J.G.-F., L.L., E.B., A.O.-P., R.H.-A., F.A., N.G., J.E., C.B., A.F.-O., B.D.N., M.d.T., E.G., C.M.); Cardiology and Hematology Department, Hospital Clinic, IDIBAPS, Barcelona, Spain (M.S., A.R., P.M.); Cardiology Department, Hospital Sant Pau, Barcelona, Spain (X.G.-M.); Department of Radiology and Nuclear Medicine, San Pedro Hospital and Centre for Biomedical Research of La Rioja (CIBIR), Logroño (La Rioja), Spain, and Institute Focuscan, Madrid, Spain (R.D.-B.); Statistic Department, Hospital Clínico San Carlos, Madrid, Spain (C.F.); and Pharmacology Department, Complutense University, Madrid, Spain (T.T., S.R.). pjimenezq@salud.madrid.org. 2. From the Cardiology and Hematology Department, Hospital Clínico San Carlos, IdISSC, Madrid, Spain (P.J.-Q., J.J.G.-F., L.L., E.B., A.O.-P., R.H.-A., F.A., N.G., J.E., C.B., A.F.-O., B.D.N., M.d.T., E.G., C.M.); Cardiology and Hematology Department, Hospital Clinic, IDIBAPS, Barcelona, Spain (M.S., A.R., P.M.); Cardiology Department, Hospital Sant Pau, Barcelona, Spain (X.G.-M.); Department of Radiology and Nuclear Medicine, San Pedro Hospital and Centre for Biomedical Research of La Rioja (CIBIR), Logroño (La Rioja), Spain, and Institute Focuscan, Madrid, Spain (R.D.-B.); Statistic Department, Hospital Clínico San Carlos, Madrid, Spain (C.F.); and Pharmacology Department, Complutense University, Madrid, Spain (T.T., S.R.).
Abstract
RATIONALE: Refractory angina constitutes a clinical problem. OBJECTIVE: The aim of this study was to assess the safety and the feasibility of transendocardial injection of CD133(+) cells to foster angiogenesis in patients with refractory angina. METHODS AND RESULTS: In this randomized, double-blinded, multicenter controlled trial, eligible patients were treated withgranulocyte colony-stimulating factor, underwent an apheresis and electromechanical mapping, and were randomized to receive treatment with CD133(+) cells or no treatment. The primary end point was the safety of transendocardial injection of CD133(+) cells, as measured by the occurrence of major adverse cardiac and cerebrovascular event at 6 months. Secondary end points analyzed the efficacy. Twenty-eight patients were included (n=19 treatment; n=9 control). At 6 months, 1 patient in each group had ventricular fibrillation and 1 patient in each group died. One patient (treatment group) had a cardiac tamponade during mapping. There were no significant differences between groups with respect to efficacy parameters; however, the comparison within groups showed a significant improvement in the number of angina episodes per month (median absolute difference, -8.5 [95% confidence interval, -15.0 to -4.0]) and in angina functional class in the treatment arm but not in the control group. At 6 months, only 1 simple-photon emission computed tomography (SPECT) parameter: summed score improved significantly in the treatment group at rest and at stress (median absolute difference, -1.0 [95% confidence interval, -1.9 to -0.1]) but not in the control arm. CONCLUSIONS: Our findings support feasibility and safety of transendocardial injection of CD133(+) cells in patients with refractory angina. The promising clinical results and favorable data observed in SPECT summed score may set up the basis to test the efficacy of cell therapy in a larger randomized trial.
RCT Entities:
RATIONALE: Refractory angina constitutes a clinical problem. OBJECTIVE: The aim of this study was to assess the safety and the feasibility of transendocardial injection of CD133(+) cells to foster angiogenesis in patients with refractory angina. METHODS AND RESULTS: In this randomized, double-blinded, multicenter controlled trial, eligible patients were treated with granulocyte colony-stimulating factor, underwent an apheresis and electromechanical mapping, and were randomized to receive treatment with CD133(+) cells or no treatment. The primary end point was the safety of transendocardial injection of CD133(+) cells, as measured by the occurrence of major adverse cardiac and cerebrovascular event at 6 months. Secondary end points analyzed the efficacy. Twenty-eight patients were included (n=19 treatment; n=9 control). At 6 months, 1 patient in each group had ventricular fibrillation and 1 patient in each group died. One patient (treatment group) had a cardiac tamponade during mapping. There were no significant differences between groups with respect to efficacy parameters; however, the comparison within groups showed a significant improvement in the number of angina episodes per month (median absolute difference, -8.5 [95% confidence interval, -15.0 to -4.0]) and in angina functional class in the treatment arm but not in the control group. At 6 months, only 1 simple-photon emission computed tomography (SPECT) parameter: summed score improved significantly in the treatment group at rest and at stress (median absolute difference, -1.0 [95% confidence interval, -1.9 to -0.1]) but not in the control arm. CONCLUSIONS: Our findings support feasibility and safety of transendocardial injection of CD133(+) cells in patients with refractory angina. The promising clinical results and favorable data observed in SPECT summed score may set up the basis to test the efficacy of cell therapy in a larger randomized trial.
Authors: April Stempien-Otero; Deri Helterline; Tabitha Plummer; Stephen Farris; Andrew Prouse; Nayak Polissar; Derek Stanford; Nahush A Mokadam Journal: J Am Coll Cardiol Date: 2015-04-14 Impact factor: 24.094
Authors: Rahman Shah; Samuel B Latham; Sajjad A Khan; Muhammad Shahreyar; Inyong Hwang; Ion S Jovin Journal: Clin Cardiol Date: 2018-04-17 Impact factor: 2.882