Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting
Tài liệu tham khảo
Young, 2015, Cell-based therapies for cardiac disease: a cellular therapist’s perspective, Transfusion, 55, 441, 10.1111/trf.12826
Raval, 2008, Therapeutic potential of adult progenitor cells in the management of chronic myocardial ischemia, Am J Cardiovasc Drugs, 8, 315, 10.2165/00129784-200808050-00004
Vrtovec, 2013, Comparison of transendocardial and intracoronary CD34+ cell transplantation in patients with nonischemic dilated cardiomyopathy, Circulation, 128, S42, 10.1161/CIRCULATIONAHA.112.000230
Perin, 2008, Comparison of intracoronary and transendocardial delivery of allogeneic mesenchymal cells in a canine model of acute myocardial infarction, J Mol Cell Cardiol, 44, 486, 10.1016/j.yjmcc.2007.09.012
de la Fuente, 2007, Transendocardial autologous bone marrow in chronic myocardial infarction using a helical needle catheter: 1-year follow-up in an open-label, nonrandomized, single-center pilot study (the TABMMI study), American Heart Journal, 154, e1, 10.1016/j.ahj.2007.04.051
Kornowski, 1999, Evaluation of the acute and chronic safety of the biosense injection catheter system in porcine hearts, Catheter Cardiovasc Interv, 48, 447, 10.1002/(SICI)1522-726X(199912)48:4<447::AID-CCD23>3.0.CO;2-Y
Ince, 2004, Transcatheter transplantation of autologous skeletal myoblasts in postinfarction patients with severe left ventricular dysfunction, J Endovasc Ther, 11, 695, 10.1583/04-1386R.1
Behfar, 2013, Optimized delivery system achieves enhanced endomyocardial stem cell retention, Circ Cardiovasc Interv, 6, 710, 10.1161/CIRCINTERVENTIONS.112.000422
Gepstein, 1997, A novel method for nonfluoroscopic catheter-based electroanatomical mapping of the heart. In vitro and in vivo accuracy results, Circulation, 95, 1611, 10.1161/01.CIR.95.6.1611
Ben-Haim, 1996, Nonfluoroscopic, in vivo navigation and mapping technology, Nat Med, 2, 1393, 10.1038/nm1296-1393
Psaltis, 2010, Intramyocardial navigation and mapping for stem cell delivery, J Cardiovasc Transl Res, 3, 135, 10.1007/s12265-009-9138-1
Losordo, 2011, Intramyocardial, autologous CD34+ cell therapy for refractory angina, Circ Res, 109, 428, 10.1161/CIRCRESAHA.111.245993
Heeger, 2012, Percutaneous, transendocardial injection of bone marrow-derived mononuclear cells in heart failure patients following acute ST-elevation myocardial infarction: ALSTER-stem cell trial, EuroIntervention, 8, 732, 10.4244/EIJV8I6A113
Henry, 2017, The Athena trials: autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricular dysfunction, Catheter Cardiovasc Interv, 89, 169, 10.1002/ccd.26601
Briguori, 2006, Direct intramyocardial percutaneous delivery of autologous bone marrow in patients with refractory myocardial angina, Am Heart J, 151, 674, 10.1016/j.ahj.2005.04.033
Dib, 2009, One-year follow-up of feasibility and safety of the first U.S., randomized, controlled study using 3-dimensional guided catheter-based delivery of autologous skeletal myoblasts for ischemic cardiomyopathy (CAuSMIC study), JACC Cardiovasc Interv, 2, 9, 10.1016/j.jcin.2008.11.003
Bartunek, 2013, Cardiopoietic stem cell therapy in heart failure: the C-CURE (Cardiopoietic stem cell therapy in heart failURE) multicenter randomized trial with lineage-specified biologics, J Am Coll Cardiol, 61, 2329, 10.1016/j.jacc.2013.02.071
Bartunek, 2017, Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial, European Heart Journal, 38, 648
Comella, 2016, Effects of the intramyocardial implantation of stromal vascular fraction in patients with chronic ischemic cardiomyopathy, J Transl Med, 14, 158, 10.1186/s12967-016-0918-5
Duckers, 2011, Final results of a phase IIa, randomised, open-label trial to evaluate the percutaneous intramyocardial transplantation of autologous skeletal myoblasts in congestive heart failure patients: the SEISMIC trial, EuroIntervention, 6, 805, 10.4244/EIJV6I7A139
Santoso, 2014, Endomyocardial implantation of autologous bone marrow mononuclear cells in advanced ischemic heart failure: a randomized placebo-controlled trial (END-HF), J Cardiovasc Transl Res, 7, 545, 10.1007/s12265-014-9580-6
Perin, 2012, Effect of transendocardial delivery of autologous bone marrow mononuclear cells on functional capacity, left ventricular function, and perfusion in chronic heart failure: the FOCUS-CCTRN trial, JAMA, 307, 10.1001/jama.2012.418
Fuchs, 2006, Safety and feasibility of transendocardial autologous bone marrow cell transplantation in patients with advanced heart disease, Am J Cardiol, 97, 823, 10.1016/j.amjcard.2005.09.132
Gwizdala, 2017, Safety, feasibility and effectiveness of first in-human administration of muscle-derived stem/progenitor cells modified with connexin-43 gene for treatment of advanced chronic heart failure, Eur J Heart Fail, 19, 148, 10.1002/ejhf.700
Henry, 2014, Safety and efficacy of ixmyelocel-T: an expanded, autologous multi-cellular therapy, in dilated cardiomyopathy, Circ Res, 115, 730, 10.1161/CIRCRESAHA.115.304554
Patel, 2016, Ixmyelocel-T for patients with ischaemic heart failure: a prospective randomised double-blind trial, Lancet, 387, 2412, 10.1016/S0140-6736(16)30137-4
Krause, 2009, Percutaneous intramyocardial stem cell injection in patients with acute myocardial infarction: first-in-man study, Heart, 95, 1145, 10.1136/hrt.2008.155077
Losordo, 2007, Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial, Circulation, 115, 10.1161/CIRCULATIONAHA.106.687376
Guijarro, 2016, Intramyocardial transplantation of mesenchymal stromal cells for chronic myocardial ischemia and impaired left ventricular function: results of the MESAMI 1 pilot trial, Int J Cardiol, 209, 258, 10.1016/j.ijcard.2016.02.016
Gyongyosi, 2009, Combined delivery approach of bone marrow mononuclear stem cells early and late after myocardial infarction: the MYSTAR prospective, randomized study, Nat Clin Pract Cardiovasc Med, 6, 70, 10.1038/ncpcardio1388
Perin, 2003, Transendocardial, autologous bone marrow cell transplantation for severe, chronic ischemic heart failure, Circulation, 107, 2294, 10.1161/01.CIR.0000070596.30552.8B
Perin, 2015, A phase II dose-escalation study of allogeneic mesenchymal precursor cells in patients with ischemic or nonischemic heart failure, Circ Res, 117, 576, 10.1161/CIRCRESAHA.115.306332
Perin EC, Silva GV, Zheng Y, Gahremanpour A, Canales J, Patel D, Fernandes MR, Keller LH, Quan X, Coulter SA, Moore WH, Herlihy JP and Willerson JT. Randomized, double-blind pilot study of transendocardial injection of autologous aldehyde dehydrogenase-bright stem cells in patients with ischemic heart failure. Am Heart J. 2012;163:415–21, 421 e1.
Hare, 2012, Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial, JAMA, 308, 10.1001/jama.2012.25321
Hare, 2017, Randomized comparison of allogeneic versus autologous mesenchymal stem cells for nonischemic dilated cardiomyopathy: POSEIDON-DCM Trial, Journal of the American College of Cardiology, 69, 526, 10.1016/j.jacc.2016.11.009
Povsic, 2011, A double-blind, randomized, controlled, multicenter study to assess the safety and cardiovascular effects of skeletal myoblast implantation by catheter delivery in patients with chronic heart failure after myocardial infarction, Am Heart J, 162, 654, 10.1016/j.ahj.2011.07.020
Tse, 2007, Prospective randomized trial of direct endomyocardial implantation of bone marrow cells for treatment of severe coronary artery diseases (PROTECT-CAD trial), Eur Heart J, 28, 2998, 10.1093/eurheartj/ehm485
Wojakowski, 2017, Effects of transendocardial delivery of bone marrow-derived CD133(+) cells on left ventricle perfusion and function in patients with refractory angina: final results of randomized, double-blinded, placebo-controlled REGENT-VSEL trial, Circ Res, 120, 670, 10.1161/CIRCRESAHA.116.309009
Smits, 2003, Catheter-based intramyocardial injection of autologous skeletal myoblasts as a primary treatment of ischemic heart failure: clinical experience with six-month follow-up, J Am Coll Cardiol, 42, 2063, 10.1016/j.jacc.2003.06.017
Heldman, 2014, Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial, JAMA, 311, 62, 10.1001/jama.2013.282909
Florea, 2017, Dose comparison study of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy (The TRIDENT Study), Circ Res, 121, 1279, 10.1161/CIRCRESAHA.117.311827
Tse, 2003, Angiogenesis in ischaemic myocardium by intramyocardial autologous bone marrow mononuclear cell implantation, Lancet, 361, 47, 10.1016/S0140-6736(03)12111-3
Vrtovec, 2016, Efficacy of CD34+ stem cell therapy in nonischemic dilated cardiomyopathy is absent in patients with diabetes but preserved in patients with insulin resistance, Stem Cells Transl Med, 5, 632, 10.5966/sctm.2015-0172
Vrtovec, 2018, Effects of repetitive transendocardial CD34(+) cell transplantation in patients with nonischemic dilated cardiomyopathy, Circ Res, 123, 389, 10.1161/CIRCRESAHA.117.312170
Williams, 2011, Intramyocardial stem cell injection in patients with ischemic cardiomyopathy: functional recovery and reverse remodeling, Circ Res, 108, 792, 10.1161/CIRCRESAHA.111.242610
Fuchs, 2006, A randomized, double-blind, placebo-controlled, multicenter, pilot study of the safety and feasibility of catheter-based intramyocardial injection of AdVEGF121 in patients with refractory advanced coronary artery disease, Catheter Cardiovasc Interv, 68, 372, 10.1002/ccd.20859
Favaloro, 2013, High-dose plasmid-mediated VEGF gene transfer is safe in patients with severe ischemic heart disease (Genesis-I). A phase I, open-label, two-year follow-up trial, Catheter Cardiovasc Interv, 82, 899, 10.1002/ccd.24555
Baldazzi, 2008, Release of biomarkers of myocardial damage after direct intramyocardial injection of genes and stem cells via the percutaneous transluminal route, Eur Heart J, 29, 1819, 10.1093/eurheartj/ehn233
Losordo, 2002, Phase 1/2 placebo-controlled, double-blind, dose-escalating trial of myocardial vascular endothelial growth factor 2 gene transfer by catheter delivery in patients with chronic myocardial ischemia, Circulation, 105, 2012, 10.1161/01.CIR.0000015982.70785.B7
Stewart, 2009, VEGF gene therapy fails to improve perfusion of ischemic myocardium in patients with advanced coronary disease: results of the NORTHERN trial, Mol Ther, 17, 1109, 10.1038/mt.2009.70
Penn, 2013, An open-label dose escalation study to evaluate the safety of administration of nonviral stromal cell-derived factor-1 plasmid to treat symptomatic ischemic heart failure, Circ Res, 112, 816, 10.1161/CIRCRESAHA.111.300440
Ripa, 2006, Intramyocardial injection of vascular endothelial growth factor-A165 plasmid followed by granulocyte-colony stimulating factor to induce angiogenesis in patients with severe chronic ischaemic heart disease, Eur Heart J, 27, 1785, 10.1093/eurheartj/ehl117
Chung, 2015, Changes in ventricular remodelling and clinical status during the year following a single administration of stromal cell-derived factor-1 non-viral gene therapy in chronic ischaemic heart failure patients: the STOP-HF randomized phase II trial, Eur Heart J, 36, 2228, 10.1093/eurheartj/ehv254
Kukula, 2011, Intramyocardial plasmid-encoding human vascular endothelial growth factor A165/basic fibroblast growth factor therapy using percutaneous transcatheter approach in patients with refractory coronary artery disease (VIF-CAD), Am Heart J, 161, 581, 10.1016/j.ahj.2010.11.023
Bassetti, 2018, Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived CD133(+) cells in ischemic refractory cardiomyopathy trial (RECARDIO), Stem Cell Res Ther, 9, 235, 10.1186/s13287-018-0969-z
Jimenez-Quevedo, 2014, Selected CD133(+) progenitor cells to promote angiogenesis in patients with refractory angina: final results of the PROGENITOR randomized trial, Circ Res, 115, 950, 10.1161/CIRCRESAHA.115.303463
Silva, 2004, Catheter-based transendocardial delivery of autologous bone-marrow-derived mononuclear cells in patients listed for heart transplantation, Tex Heart Inst J, 31, 214
Perin, 2014, Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: the PRECISE trial, Am Heart J, 168, 88, 10.1016/j.ahj.2014.03.022
Kastrup, 2005, Direct intramyocardial plasmid vascular endothelial growth factor-A165 gene therapy in patients with stable severe angina pectoris a randomized double-blind placebo-controlled study: the Euroinject one trial, J Am Coll Cardiol, 45, 982, 10.1016/j.jacc.2004.12.068
Perin, 2006, Methods of stem cell delivery in cardiac diseases, Nat Clin Pract Cardiovasc Med, 3, S110, 10.1038/ncpcardio0447
Mitsutake, 2017, Improvement of local cell delivery using helix transendocardial delivery catheter in a porcine heart, Int Heart J, 58, 435, 10.1536/ihj.16-179
Dick, 2003, Magnetic resonance fluoroscopy allows targeted delivery of mesenchymal stem cells to infarct borders in swine, Circulation, 108, 2899, 10.1161/01.CIR.0000095790.28368.F9
Corti, 2005, Real time magnetic resonance guided endomyocardial local delivery, Heart, 91, 348, 10.1136/hrt.2004.034363
Karmarkar, 2004, MR-trackable intramyocardial injection catheter, Magn Reson Med, 51, 1163, 10.1002/mrm.20086
Hatt, 2013, MRI-3D ultrasound-X-ray image fusion with electromagnetic tracking for transendocardial therapeutic injections: in-vitro validation and in-vivo feasibility, Comput Med Imaging Graph, 37, 162, 10.1016/j.compmedimag.2013.03.006
Schmuck, 2015, Intravenous followed by X-ray fused with MRI-guided transendocardial mesenchymal stem cell injection improves contractility reserve in a swine model of myocardial infarction, J Cardiovasc Transl Res, 8, 438, 10.1007/s12265-015-9654-0
Tomkowiak, 2011, Targeted transendocardial therapeutic delivery guided by MRI-x-ray image fusion, Catheter Cardiovasc Interv, 78, 468
de Silva, 2006, X-ray fused with magnetic resonance imaging (XFM) to target endomyocardial injections: validation in a swine model of myocardial infarction, Circulation, 114, 2342, 10.1161/CIRCULATIONAHA.105.598524
Wagner, 2018, A dynamic model-based approach to motion and deformation tracking of prosthetic valves from biplane x-ray images, Med Phys, 45, 2583, 10.1002/mp.12913
Wagner, 2016, 4D interventional device reconstruction from biplane fluoroscopy, Med Phys, 43, 1324, 10.1118/1.4941950
Povsic, 2012, Incidence and clinical significance of cardiac biomarker elevation during stem cell mobilization, apheresis, and intramyocardial delivery: an analysis from ACT34-CMI, Am Heart J, 164, 689, 10.1016/j.ahj.2012.06.022
Leon, 2011, Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the valve academic research consortium, J Am Coll Cardiol, 57, 253, 10.1016/j.jacc.2010.12.005
Mehran, 2011, Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the bleeding academic research consortium, Circulation, 123, 2736, 10.1161/CIRCULATIONAHA.110.009449
Borow, 2019, Phase 3 DREAM-HF trial of mesenchymal precursor cells in chronic heart failure, Circ Res, 125, 265, 10.1161/CIRCRESAHA.119.314951
Raval, 2018, The CardiAMP heart failure trial: a randomized controlled pivotal trial of high-dose autologous bone marrow mononuclear cells using the CardiAMP cell therapy system in patients with post-myocardial infarction heart failure: trial rationale and study design, Am Heart J, 201, 141, 10.1016/j.ahj.2018.03.016
de la Fuente, 2011, Tansendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label Phase I safety study (the TABMMI study), Eurointervention, 7, 805, 10.4244/EIJV7I7A127