PMID- 31526779 OWN - NLM STAT- MEDLINE DCOM- 20200527 LR - 20240427 IS - 1552-6259 (Electronic) IS - 0003-4975 (Print) IS - 0003-4975 (Linking) VI - 109 IP - 4 DP - 2020 Apr TI - Intramyocardial Bone Marrow Stem Cells in Patients Undergoing Cardiac Surgical Revascularization. PG - 1142-1149 LID - S0003-4975(19)31394-3 [pii] LID - 10.1016/j.athoracsur.2019.07.093 [doi] AB - BACKGROUND: Bone marrow stromal or stem cells (BMSCs) remain a promising potential therapy for ischemic cardiomyopathy. The primary objective of this study was to evaluate the safety and feasibility of direct intramyocardial injection of autologous BMSCs in patients undergoing transmyocardial revascularization (TMR) or coronary artery bypass graft surgery (CABG). METHODS: A phase I trial was conducted on adult patients who had ischemic heart disease with depressed left ventricular ejection fraction and who were scheduled to undergo TMR or CABG. Autologous BMSCs were expanded for 3 weeks before the scheduled surgery. After completion of surgical revascularization, BMSCs were directly injected into ischemic myocardium. Safety and feasibility of therapy were assessed. Cardiac functional status and changes in quality of life were evaluated at 1 year. RESULTS: A total of 14 patients underwent simultaneous BMSC and surgical revascularization therapy (TMR+BMSCs = 10; CABG+BMSCs = 4). BMSCs were successfully expanded, and no significant complications occurred as a result of the procedure. Regional contractility in the cell-treated areas demonstrated improvement at 12 months compared with baseline (TMR+BMSCs Delta strain: -4.6% +/- 2.1%; P = .02; CABG+MSCs Delta strain: -4.2% +/- 6.0%; P = .30). Quality of life was enhanced, with substantial reduction in angina scores at 1 year after treatment (TMR+BMSCs: 1.3 +/- 1.2; CABG+MSCs: 1.0 +/- 1.4). CONCLUSIONS: In this phase I trial, direct intramyocardial injection of autologous BMSCs in conjunction with TMR or CABG was technically feasible and could be performed safely. Preliminary results demonstrate improved cardiac function and quality of life in patients at 1 year after treatment. CI - Copyright (c) 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved. FAU - Chan, Joshua L AU - Chan JL AD - Cardiothoracic Surgery Research Program, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland. FAU - Miller, Justin G AU - Miller JG AD - Cardiothoracic Surgery Research Program, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland. FAU - Zhou, Yifu AU - Zhou Y AD - Cardiothoracic Surgery Research Program, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland. FAU - Robey, Pamela G AU - Robey PG AD - NIH Bone Marrow Stromal Cell Transplantation Center, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, Maryland. FAU - Stroncek, David F AU - Stroncek DF AD - Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland. FAU - Arai, Andrew E AU - Arai AE AD - Advanced Cardiovascular Imaging Group, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland. FAU - Sachdev, Vandana AU - Sachdev V AD - Echocardiography Laboratory, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland. FAU - Horvath, Keith A AU - Horvath KA AD - Cardiothoracic Surgery Research Program, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: khorvath@aamc.org. LA - eng GR - HHSN268201300001C/HB/NHLBI NIH HHS/United States GR - U01 CA224766/CA/NCI NIH HHS/United States GR - ZIB DE000730/ImNIH/Intramural NIH HHS/United States PT - Clinical Trial, Phase I PT - Journal Article PT - Multicenter Study PT - Research Support, N.I.H., Extramural DEP - 20190914 PL - Netherlands TA - Ann Thorac Surg JT - The Annals of thoracic surgery JID - 15030100R SB - IM CIN - Ann Thorac Surg. 2020 Dec;110(6):2104. PMID: 32497645 CIN - Ann Thorac Surg. 2020 Dec;110(6):2104-2105. PMID: 32504595 MH - Coronary Angiography MH - Feasibility Studies MH - Female MH - Follow-Up Studies MH - Humans MH - Injections MH - Male MH - Mesenchymal Stem Cell Transplantation/*methods MH - Mesenchymal Stem Cells/*cytology MH - Middle Aged MH - Myocardial Contraction/*physiology MH - Myocardial Ischemia/diagnosis/physiopathology/*therapy MH - Myocardial Revascularization/*methods MH - Myocardium MH - Preoperative Care/*methods MH - Quality of Life MH - Ventricular Function, Left/*physiology PMC - PMC8045460 MID - NIHMS1544312 EDAT- 2019/09/19 06:00 MHDA- 2020/05/28 06:00 PMCR- 2021/04/14 CRDT- 2019/09/19 06:00 PHST- 2019/01/21 00:00 [received] PHST- 2019/07/04 00:00 [revised] PHST- 2019/07/29 00:00 [accepted] PHST- 2019/09/19 06:00 [pubmed] PHST- 2020/05/28 06:00 [medline] PHST- 2019/09/19 06:00 [entrez] PHST- 2021/04/14 00:00 [pmc-release] AID - S0003-4975(19)31394-3 [pii] AID - 10.1016/j.athoracsur.2019.07.093 [doi] PST - ppublish SO - Ann Thorac Surg. 2020 Apr;109(4):1142-1149. doi: 10.1016/j.athoracsur.2019.07.093. Epub 2019 Sep 14.