title: Safety and feasibility of intramyocardial versus intracoronary delivery of autologous cell therapy in advanced heart failure: the REGENERATE-IHD pilot study.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  Peripheral mobilization of BMSCs with or without subsequent direct myocardial delivery appears safe and feasible in patients with chronic ischemic heart failure.
authors.affiliation: Department of Cardiology, London Chest Hospital, Barts Health Trust, London, E2 9JX, UK.
authors.forename: Abdul
authors.initials: A
authors.lastname: Mozid
authors.forename: Chia
authors.initials: C
authors.lastname: Yeo
authors.forename: Samer
authors.initials: S
authors.lastname: Arnous
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Ako
authors.forename: Natalie
authors.initials: N
authors.lastname: Saunders
authors.forename: Didier
authors.initials: D
authors.lastname: Locca
authors.forename: Pat
authors.initials: P
authors.lastname: Brookman
authors.forename: R Andrew
authors.initials: RA
authors.lastname: Archbold
authors.forename: Martin
authors.initials: M
authors.lastname: Rothman
authors.forename: Peter
authors.initials: P
authors.lastname: Mills
authors.forename: Samir
authors.initials: S
authors.lastname: Agrawal
authors.forename: John
authors.initials: J
authors.lastname: Martin
authors.forename: Anthony
authors.initials: A
authors.lastname: Mathur
mesh_terms: D016026:Bone Marrow Transplantation / Q000379:methods*; D004333:Drug Administration Routes; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000494:pharmacology; D006321:Heart; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D009206:Myocardium; D020097:Natriuretic Peptide, Brain / Q000008:administration & dosage / Q000494:pharmacology; D010446:Peptide Fragments / Q000008:administration & dosage / Q000494:pharmacology; D010865:Pilot Projects; D014182:Transplantation, Autologous
chemical_list: D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain; D016179:Granulocyte Colony-Stimulating Factor
keywords: autologous bone marrow-derived stem/progenitor cells; chronic ischemic heart failure; granulocyte-colony stimulating factor; intracoronary delivery; intramyocardial delivery