Safety and feasibility of intramyocardial versus intracoronary delivery of autologous cell therapy in advanced heart failure: the REGENERATE-IHD pilot study.

Abstract:

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.

journal_name

Regen Med

journal_title

Regenerative medicine

authors

Mozid A,Yeo C,Arnous S,Ako E,Saunders N,Locca D,Brookman P,Archbold RA,Rothman M,Mills P,Agrawal S,Martin J,Mathur A

doi

10.2217/rme.14.3

subject

Has Abstract

pub_date

2014-05-01 00:00:00

pages

269-78

issue

3

eissn

1746-0751

issn

1746-076X

journal_volume

9

pub_type

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