Safety and Feasibility of Intramyocardial Versus Intracoronary Delivery of Autologous Cell Therapy in Advanced Heart Failure: The REGENERATE-IHD Pilot Study

• DOI: 10.2217/rme.14.3
• Publication Date: 2014-06-17T12:39:59Z
• Authors: Abdul Mozid; Chia Yeo; Samer Arnous; Emmanuel Ako; Natalie Saunders; Didier Locca; Pat Brookman; R Andrew Archbold; Martin Rothman; Peter Mills; Samir Agrawal; John Martin; Anthony Mathur
• Keywords: Heart Failure; 0301 basic medicine; Drug Administration Routes; Myocardium; Heart; Pilot Projects; Transplantation, Autologous; Peptide Fragments; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Granulocyte Colony-Stimulating Factor; Natriuretic Peptide, Brain; Humans; Bone Marrow Transplantation

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.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.Peripheral mobilization of BMSCs with or without subsequent direct myocardial delivery appears safe and feasible in patients with chronic ischemic heart failure.