PMID- 24935040 OWN - NLM STAT- MEDLINE DCOM- 20150202 LR - 20140617 IS - 1746-076X (Electronic) IS - 1746-0751 (Linking) VI - 9 IP - 3 DP - 2014 May TI - Safety and feasibility of intramyocardial versus intracoronary delivery of autologous cell therapy in advanced heart failure: the REGENERATE-IHD pilot study. PG - 269-78 LID - 10.2217/rme.14.3 [doi] AB - 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. FAU - Mozid, Abdul AU - Mozid A AD - Department of Cardiology, London Chest Hospital, Barts Health Trust, London, E2 9JX, UK. FAU - Yeo, Chia AU - Yeo C FAU - Arnous, Samer AU - Arnous S FAU - Ako, Emmanuel AU - Ako E FAU - Saunders, Natalie AU - Saunders N FAU - Locca, Didier AU - Locca D FAU - Brookman, Pat AU - Brookman P FAU - Archbold, R Andrew AU - Archbold RA FAU - Rothman, Martin AU - Rothman M FAU - Mills, Peter AU - Mills P FAU - Agrawal, Samir AU - Agrawal S FAU - Martin, John AU - Martin J FAU - Mathur, Anthony AU - Mathur A LA - eng GR - Medical Research Council/United Kingdom PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Regen Med JT - Regenerative medicine JID - 101278116 RN - 0 (Peptide Fragments) RN - 0 (pro-brain natriuretic peptide (1-76)) RN - 114471-18-0 (Natriuretic Peptide, Brain) RN - 143011-72-7 (Granulocyte Colony-Stimulating Factor) SB - IM MH - Bone Marrow Transplantation/*methods MH - *Drug Administration Routes MH - Granulocyte Colony-Stimulating Factor/administration & dosage/pharmacology MH - *Heart MH - Heart Failure/*therapy MH - Humans MH - *Myocardium MH - Natriuretic Peptide, Brain/administration & dosage/pharmacology MH - Peptide Fragments/administration & dosage/pharmacology MH - Pilot Projects MH - Transplantation, Autologous OTO - NOTNLM OT - autologous bone marrow-derived stem/progenitor cells OT - chronic ischemic heart failure OT - granulocyte-colony stimulating factor OT - intracoronary delivery OT - intramyocardial delivery EDAT- 2014/06/18 06:00 MHDA- 2015/02/03 06:00 CRDT- 2014/06/18 06:00 PHST- 2014/06/18 06:00 [entrez] PHST- 2014/06/18 06:00 [pubmed] PHST- 2015/02/03 06:00 [medline] AID - 10.2217/rme.14.3 [doi] PST - ppublish SO - Regen Med. 2014 May;9(3):269-78. doi: 10.2217/rme.14.3.