AIM: This study presents an interim safety and feasibility analysis of the REGENERATE-IHD randomized controlled trial, which is examining the safety and efficacy of three different delivery routes of bone marrow-derived stem cells (BMSCs) in patients with ischemic heart failure. METHODS & RESULTS: The first 58 patients recruited to the REGENERATE-IHD study are included in this interim analysis (pilot). Symptomatic patients with ischemic heart failure were randomized to receive subcutaneous granulocyte colony-stimulating factor or saline injections only; or subcutaneous granulocyte colony-stimulating factor injections followed by intracoronary or intramyocardial injections of BMSCs or serum (control). No significant differences were found in terms of safety and feasibility between the different delivery routes, with no significant difference in procedural complications or major adverse cardiac events. There was a signal towards improved heart failure symptoms in the patients treated with intramyocardial injection of mobilized BMSCs. CONCLUSION: Peripheral mobilization of BMSCs with or without subsequent direct myocardial delivery appears safe and feasible in patients with chronic ischemic heart failure.
RCT Entities:
AIM: This study presents an interim safety and feasibility analysis of the REGENERATE-IHD randomized controlled trial, which is examining the safety and efficacy of three different delivery routes of bone marrow-derived stem cells (BMSCs) in patients with ischemic heart failure. METHODS & RESULTS: The first 58 patients recruited to the REGENERATE-IHD study are included in this interim analysis (pilot). Symptomatic patients with ischemic heart failure were randomized to receive subcutaneous granulocyte colony-stimulating factor or saline injections only; or subcutaneous granulocyte colony-stimulating factor injections followed by intracoronary or intramyocardial injections of BMSCs or serum (control). No significant differences were found in terms of safety and feasibility between the different delivery routes, with no significant difference in procedural complications or major adverse cardiac events. There was a signal towards improved heart failure symptoms in the patients treated with intramyocardial injection of mobilized BMSCs. CONCLUSION: Peripheral mobilization of BMSCs with or without subsequent direct myocardial delivery appears safe and feasible in patients with chronic ischemic heart failure.
Authors: Tawfiq Choudhury; Abdul Mozid; Steve Hamshere; Chia Yeo; Cyril Pellaton; Samer Arnous; Natalie Saunders; Pat Brookman; Ajay Jain; Didier Locca; Andrew Archbold; Charles Knight; Andrew Wragg; Ceri Davies; Peter Mills; Mahesh Parmar; Martin Rothman; Fizzah Choudry; Daniel A Jones; Samir Agrawal; John Martin; Anthony Mathur Journal: Eur J Heart Fail Date: 2016-10-28 Impact factor: 15.534
Authors: Francisco Fernández-Avilés; Ricardo Sanz-Ruiz; Andreu M Climent; Lina Badimon; Roberto Bolli; Dominique Charron; Valentin Fuster; Stefan Janssens; Jens Kastrup; Hyo-Soo Kim; Thomas F Lüscher; John F Martin; Philippe Menasché; Robert D Simari; Gregg W Stone; Andre Terzic; James T Willerson; Joseph C Wu Journal: Eur Heart J Date: 2017-09-01 Impact factor: 29.983
Authors: Antonio Carlos Campos de Carvalho; Tais H Kasai-Brunswick; Adriana Bastos Carvalho Journal: Front Pharmacol Date: 2021-04-12 Impact factor: 5.810