A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of Intravenous Adult Human Mesenchymal Stem Cells (Prochymal) After Acute Myocardial Infarction

Journal of the American College of Cardiology - Tập 54 - Trang 2277-2286 - 2009
Joshua M. Hare1, Jay H. Traverse2, Timothy D. Henry2, Nabil Dib3, Robert K. Strumpf3, Steven P. Schulman4, Gary Gerstenblith4, Anthony N. DeMaria5, Ali E. Denktas6, Roger S. Gammon7, James B. Hermiller8, Mark A. Reisman9, Gary L. Schaer10, Warren Sherman11
1Department of Medicine, Cardiovascular Division and the Interdisciplinary Stem Cell Institute, Miller School of Medicine, University of Miami, Miami, Florida
2Minneapolis Heart Institute, Minneapolis, Minnesota
3Arizona Heart Institute, Phoenix, Arizona
4The Johns Hopkins Hospital, Baltimore, Maryland
5University of California San Diego, San Diego, California.
6University of Texas Houston Medical School, Houston, Texas
7Heart Hospital of Austin, Austin, Texas
8The Care Group, LLC, Indianapolis, Indiana
9Swedish Medical Center, Seattle, Washington
10Rush University Medical Center, Chicago, Illinois
11New York Presbyterian Hospital, New York, New York

Tài liệu tham khảo

Boyle, 2006, Is stem cell therapy ready for patients?, Circulation, 114, 339, 10.1161/CIRCULATIONAHA.105.590653

Abdel-Latif, 2007, Adult bone marrow-derived cells for cardiac repair: a systematic review and meta-analysis, Arch Intern Med, 167, 989, 10.1001/archinte.167.10.989

Schachinger, 2006, Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction, N Engl J Med, 355, 1210, 10.1056/NEJMoa060186

van der, 2008, Bone marrow cell therapy after acute myocardial infarction: the HEBE trial in perspective, first results, Neth Heart J, 16, 436, 10.1007/BF03086194

Dill, 2009, Am Heart J, 157, 541, 10.1016/j.ahj.2008.11.011

Schaefer, 2006, Impact of intracoronary bone marrow cell transfer on diastolic function in patients after acute myocardial infarction: results from the BOOST trial, Eur Heart J, 27, 929, 10.1093/eurheartj/ehi817

Assmus, 2007, Transcoronary transplantation of functionally competent BMCs is associated with a decrease in natriuretic peptide serum levels and improved survival of patients with chronic postinfarction heart failure: results of the TOPCARE-CHD registry, Circ Res, 100, 1234, 10.1161/01.RES.0000264508.47717.6b

Schuleri, 2007, Mesenchymal stem cells for cardiac regenerative therapy, Handb Exp Pharmacol, 180, 195, 10.1007/978-3-540-68976-8_9

Chamberlain, 2007, Concise review: mesenchymal stem cells: their phenotype, differentiation capacity, immunological features, and potential for homing, Stem Cells, 25, 2739, 10.1634/stemcells.2007-0197

Rubio, 2005, Spontaneous human adult stem cell transformation, Cancer Res, 65, 3035, 10.1158/0008-5472.CAN-04-4194

Breitbach, 2007, Potential risks of bone marrow cell transplantation into infarcted hearts, Blood, 110, 1362, 10.1182/blood-2006-12-063412

Vulliet, 2004, Intra-coronary arterial injection of mesenchymal stromal cells and microinfarction in dogs, Lancet, 363, 783, 10.1016/S0140-6736(04)15695-X

1985, The Thrombolysis In Myocardial Infarction (TIMI) trial, N Engl J Med, 312, 932, 10.1056/NEJM198504043121437

Gibson, 2000, Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs, Circulation, 101, 125, 10.1161/01.CIR.101.2.125

Schiller, 1989, Recommendations for quantitation of the left ventricle by two-dimensional echocardiography, J Am Soc Echocardiogr, 2, 358, 10.1016/S0894-7317(89)80014-8

Kwong, 2003, Detecting acute coronary syndrome in the emergency department with cardiac magnetic resonance imaging, Circulation, 107, 531, 10.1161/01.CIR.0000047527.11221.29

Miller, 2005, Standardisation of spirometry, Eur Respir J, 26, 319, 10.1183/09031936.05.00034805

2002, ATS statement: guidelines for the six-minute walk test, Am J Respir Crit Care Med, 166, 111, 10.1164/ajrccm.166.1.at1102

Meyer, 2006, Intracoronary bone marrow cell transfer after myocardial infarction: eighteen months' follow-up data from the randomized, controlled BOOST (BOne marrOw transfer to enhance ST-elevation infarct regeneration) trial, Circulation, 113, 1287, 10.1161/CIRCULATIONAHA.105.575118

Bartunek, 2006, The consensus of the task force of the European Society of Cardiology concerning the clinical investigation of the use of autologous adult stem cells for repair of the heart, Eur Heart J, 27, 1338, 10.1093/eurheartj/ehi793

Dai, 2005, Allogeneic mesenchymal stem cell transplantation in postinfarcted rat myocardium: short- and long-term effects, Circulation, 112, 214, 10.1161/CIRCULATIONAHA.104.527937

Freyman, 2006, A quantitative, randomized study evaluating three methods of mesenchymal stem cell delivery following myocardial infarction, Eur Heart J, 27, 1114, 10.1093/eurheartj/ehi818

Kraitchman, 2003, In vivo magnetic resonance imaging of mesenchymal stem cells in myocardial infarction, Circulation, 107, 2290, 10.1161/01.CIR.0000070931.62772.4E

Silva, 2005, Mesenchymal stem cells differentiate into an endothelial phenotype, enhance vascular density, and improve heart function in a canine chronic ischemia model, Circulation, 111, 150, 10.1161/01.CIR.0000151812.86142.45

Amado, 2005, Cardiac repair with intra-myocardial injection of allogeneic mesenchymal stem cells following myocardial infarction, Proc Natl Acad Sci U S A, 102, 11474, 10.1073/pnas.0504388102

Quevedo, 2009, Allogeneic mesenchymal stem cells restore cardiac function in chronic ischemic cardiomyopathy via trilineage differentiating capacity, Proc Natl Acad Sci U S A, 106, 14022, 10.1073/pnas.0903201106

Burns, 2005, Tumorigenic heterogeneity in cancer stem cells evolved from long-term cultures of telomerase-immortalized human mesenchymal stem cells, Cancer Res, 65, 3126, 10.1158/0008-5472.CAN-04-2218

Chin, 2003, 111In oxine labelled mesenchymal stem cell SPECT after intravenous administration in myocardial infarction, Nucl Med Commun, 24, 1149, 10.1097/00006231-200311000-00005

Ringden, 2006, Mesenchymal stem cells for treatment of therapy-resistant graft-versus-host disease, Transplantation, 81, 1390, 10.1097/01.tp.0000214462.63943.14

Horwitz, 2002, Isolated allogeneic bone marrow-derived mesenchymal cells engraft and stimulate growth in children with osteogenesis imperfecta: implications for cell therapy of bone, Proc Natl Acad Sci U S A, 99, 8932, 10.1073/pnas.132252399

Koc, 2002, Allogeneic mesenchymal stem cell infusion for treatment of metachromatic leukodystrophy (MLD) and Hurler syndrome (MPS-IH), Bone Marrow Transplant, 30, 215, 10.1038/sj.bmt.1703650

Mazhari, 2007, Mechanisms of action of mesenchymal stem cells in cardiac repair: potential influences on the cardiac stem cell niche, Nat Clin Pract Cardiovasc Med, 4, S21, 10.1038/ncpcardio0770

Mirotsou, 2007, Secreted frizzled related protein 2 (Sfrp2) is the key Akt-mesenchymal stem cell-released paracrine factor mediating myocardial survival and repair, Proc Natl Acad Sci U S A, 104, 1643, 10.1073/pnas.0610024104

Anversa, 2006, Life and death of cardiac stem cells: a paradigm shift in cardiac biology, Circulation, 113, 1451, 10.1161/CIRCULATIONAHA.105.595181

Urbanek, 2006, Stem cell niches in the adult mouse heart, Proc Natl Acad Sci U S A, 103, 9226, 10.1073/pnas.0600635103

Gnecchi, 2009, Early beneficial effects of bone marrow-derived mesenchymal stem cells overexpressing Akt on cardiac metabolism after myocardial infarction, Stem Cells, 27, 971, 10.1002/stem.12