Phases I-III clinical trials using adult stem cells

Stem Cells International

Volumn , Issue , 2010, Pages

  Fernández Avilés, Francisco ^a   Sanz Ruiz, Ricardo ^a   Gutiérrez Ibañes, Enrique ^a   Arranz, Adolfo Villa ^a   Fernández Santos, María Eugenia ^a   Fernández, Pedro L Sánchez ^a  

^a HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

AVE 9488; GRANULOCYTE COLONY STIMULATING FACTOR; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; NITRIC OXIDE DONOR; ROSIGLITAZONE; UNCLASSIFIED DRUG;

ACUTE HEART INFARCTION; ADIPOSE DERIVED STEM CELL; ADULT; ANGIOGENESIS; AUTOLOGOUS STEM CELL TRANSPLANTATION; CELL DIFFERENTIATION; CELL SURVIVAL; CHEMICAL REACTION; CONCEPTUAL FRAMEWORK; HEART DEVELOPMENT; HEART FAILURE; HEART INFARCTION PREVENTION; HEART LEFT VENTRICLE CONTRACTILITY; HEART LEFT VENTRICLE EJECTION FRACTION; HEART MUSCLE BLOOD FLOW; HEART MUSCLE ISCHEMIA; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; MEDICAL ETHICS; MESENCHYMAL STEM CELL TRANSPLANTATION; METHODOLOGY; MUSCLE DEVELOPMENT; NONHUMAN; PARACRINE SIGNALING; PATIENT SELECTION; PERIPHERAL BLOOD STEM CELL TRANSPLANTATION; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RADIOCARDIOGRAPHY; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; TISSUE REGENERATION; TISSUE REPAIR;

EID: 79959401934     PISSN: None     EISSN: 16879678     Source Type: Journal    
DOI: 10.4061/2010/579142     Document Type: Review

References (46)

1. Wollert K. C., Drexler H., Cell therapy for the treatment of coronary heart disease: a critical appraisal Nature Reviews Cardiology 2010 7 4 204 215
2. Chen S.-L., Fang W.-W., Ye F., Liu Y.-H., Qian J., Shan S.-J., Zhang J.-J., Chunhua R. Z., Liao L.-M., Lin S., Sun J.-P., Effect on left ventricular function of intracoronary transplantation of autologous bone marrow mesenchymal stem cell in patients with acute myocardial infarction American Journal of Cardiology 2004 94 1 92 95 (Pubitemid 38813459)
3. Wollert K. C., Meyer G. P., Lotz J., Ringes-Lichtenberg S., Lippolt P., Breidenbach C., Fichtner S., Korte T., Hornig B., Messinger D., Arseniev L., Hertenstein B., Ganser A., Drexler H., Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial Lancet 2004 364 9429 141 148 (Pubitemid 38891685)
4. Schchinger V., Erbs S., Elssser A., Haberbosch W., Hambrecht R., Hlschermann H., Yu J., Corti R., Mathey D. G., Hamm C. W., Sselbeck T., Assmus B., Tonn T., Dimmeler S., Zeiher A. M., Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction New England Journal of Medicine 2006 355 12 1210 1221 (Pubitemid 44427445)
5. Janssens S., Dubois C., Bogaert J., Theunissen K., Deroose C., Desmet W., Kalantzi M., Herbots L., Sinnaeve P., Dens J., Maertens J., Rademakers F., Dymarkowski S., Gheysens O., Van Cleemput J., Bormans G., Nuyts J., Belmans A., Mortelmans L., Boogaerts M., Van De Werf F., Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: double-blind, randomised controlled trial Lancet 2006 367 9505 113 121 (Pubitemid 43077127)
6. Lunde K., Solheim S., Aakhus S., Arnesen H., Abdelnoor M., Egeland T., Endresen K., Ilebekk A., Mangschau A., Fjeld J. G., Smith H. J., Taraldsrud E., Grgaard H. K., Bjrnerheim R., Brekke M., Mller C., Hopp E., Ragnarsson A., Brinchmann J. E., Forfang K., Intracoronary injection of mononuclear bone marrow cells in acute myocardial infarction New England Journal of Medicine 2006 355 12 1199 1209 (Pubitemid 44427444)
7. Ge J., Li Y., Qian J., Shi J., Wang Q., Niu Y., Fan B., Liu X., Zhang S., Sun A., Zou Y., Efficacy of emergent transcatheter transplantation of stem cells for treatment of acute myocardial infarction (TCT-STAMI) Heart 2006 92 12 1764 1767 (Pubitemid 44851319)
8. Huikuri H. V., Kervinen K., Niemel M., Ylitalo K., Sily M., Koistinen P., Savolainen E.-R., Ukkonen H., Pietil M., Airaksinen J. K. E., Knuuti J., Mkikallio T. H., Effects of intracoronary injection of mononuclear bone marrow cells on left ventricular function, arrhythmia risk profile, and restenosis after thrombolytic therapy of acute myocardial infarction European Heart Journal 2008 29 22 2723 2732
9. Meluzn J., Mayer J., Groch L., Autologous transplantation of mononuclear bone marrow cells in patients with acute myocardial infarction: the effect of the dose of transplanted cells on myocardial function American Heart Journal 2006 152 5 e9 e15
10. Penicka M., Horak J., Kobylka P., Pytlik R., Kozak T., Belohlavek O., Lang O., Skalicka H., Simek S., Palecek T., Linhart A., Aschermann M., Widimsky P., Intracoronary injection of autologous bone marrow-derived mononuclear cells in patients with large anterior acute myocardial infarction: a prematurely terminated randomized study Journal of the American College of Cardiology 2007 49 24 2373 2374 (Pubitemid 46891709)
11. Van Der Laan A. M., Hirsch A., Nijveldt R., Van Der Vleuten P. A., Van Der Giessen W. J., Doevendans P. A., Waltenberger J., Ten Berg J. M., Aengevaeren W. R. M., Zwaginga J. J., Biemond B. J., Van Rossum A. C., Tijssen J. G. P., Zijlstra F., Piek J. J., Bone marrow cell therapy after acute myocardial infarction: the HEBE trial in perspective, first results Netherlands Heart Journal 2008 16 12 436 439
12. Tendera M., Wojakowski W., Ruzyllo W., Chojnowska L., Kpka C., Tracz W., Musiaek P., Piwowarska W., Nessler J., Buszman P., Grajek S., Brborowicz P., Majka M., Ratajczak M. Z., Intracoronary infusion of bone marrow-derived selected CD34 + CXCR4 + cells and non-selected mononuclear cells in patients with acute STEMI and reduced left ventricular ejection fraction: results of randomized, multicentre Myocardial Regeneration by Intracoronary Infusion of Selected Population of Stem Cells in Acute Myocardial Infarction (REGENT) Trial European Heart Journal 2009 30 11 1313 1321
13. Lipinski M. J., Biondi-Zoccai G. G. L., Abbate A., Khianey R., Sheiban I., Bartunek J., Vanderheyden M., Kim H.-S., Kang H.-J., Strauer B. E., Vetrovec G. W., Impact of intracoronary cell therapy on left ventricular function in the setting of acute myocardial infarction. A collaborative systematic review and meta-analysis of controlled clinical trials Journal of the American College of Cardiology 2007 50 18 1761 1767 (Pubitemid 47600592)
14. Martin-Rendon E., Brunskill S. J., Hyde C. J., Stanworth S. J., Mathur A., Watt S. M., Autologous bone marrow stem cells to treat acute myocardial infarction: a systematic review European Heart Journal 2008 29 15 1807 1818
15. Hare J. M., Traverse J. H., Henry T. D., Dib N., Strumpf R. K., Schulman S. P., Gerstenblith G., DeMaria A. N., Denktas A. E., Gammon R. S., Hermiller J. B. Jr., Reisman M. A., Schaer G. L., Sherman W., 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 2009 54 24 2277 2286
16. Ince H., Petzsch M., Kleine H. D., Schmidt H., Rehders T., Krber T., Schmichen C., Freund M., Nienaber C. A., Preservation from left ventricular remodeling by front-integrated revascularization and stem cell liberation in evolving acute myocardial infarction by use of granulocyte-colony-stimulating factor (FIRSTLINE-AMI) Circulation 2005 112 20 3097 3106 (Pubitemid 43113441)
17. Leone A. M., Galiuto L., Garramone B., Rutella S., Giannico M. B., Brugaletta S., Perfetti M., Liuzzo G., Porto I., Burzotta F., Niccoli G., Biasucci L. M., Leone G., Rebuzzi A. G., Crea F., Usefulness of granulocyte colony-stimulating factor in patients with a large anterior wall acute myocardial infarction to prevent left ventricular remodeling (the rigenera study) American Journal of Cardiology 2007 100 3 397 403 (Pubitemid 47094686)
18. Takano H., Hasegawa H., Kuwabara Y., Nakayama T., Matsuno K., Miyazaki Y., Yamamoto M., Fujimoto Y., Okada H., Okubo S., Fujita M., Shindo S., Kobayashi Y., Komiyama N., Takekoshi N., Imai K., Himi T., Ishibashi I., Komuro I., Feasibility and safety of granulocyte colony-stimulating factor treatment in patients with acute myocardial infarction International Journal of Cardiology 2007 122 1 41 47 (Pubitemid 47503345)
19. Kang H.-J., Kim H.-S., Zhang S.-Y., Park K.-W., Cho H.-J., Koo B.-K., Kim Y.-J., Lee D. S., Sohn D.-W., Han K.-S., Oh B.-H., Lee M.-M., Park Y.-B., Effects of intracoronary infusion of peripheral blood stem-cells mobilised with granulocyte-colony stimulating factor on left ventricular systolic function and restenosis after coronary stenting in myocardial infarction: the MAGIC cell randomised clinical trial Lancet 2004 363 9411 751 756 (Pubitemid 38315164)
20. Kang H.-J., Lee H.-Y., Na S.-H., Chang S.-A., Park K.-W., Kim H.-K., Kim S.-Y., Chang H.-J., Lee W., Kang W. J., Koo B.-K., Kim Y.-J., Lee D. S., Sohn D.-W., Han K.-S., Oh B.-H., Park Y.-B., Kim H.-S., Differential effect of intracoronary infusion of mobilized peripheral blood stem cells by granulocyte colony-stimulating factor on left ventricular function and remodeling in patients with acute myocardial infarction versus old myocardial infarction: the MAGIC cell-3-DES randomized, controlled trial Circulation 2006 114 1, supplement 1 I145 I151
21. Menasché P., Alfieri O., Janssens S., McKenna W., Reichenspurner H., Trinquart L., Vilquin J.-T., Marolleau J.-P., Seymour B., Larghero J., Lake S., Chatellier G., Solomon S., Desnos M., Hagge A. A., The myoblast autologous grafting in ischemic cardiomyopathy (MAGIC) trial: first randomized placebo-controlled study of myoblast transplantation Circulation 2008 117 9 1189 1200 (Pubitemid 351552018)
22. Dib N., Michler R. E., Pagani F. D., Wright S., Kereiakes D. J., Lengerich R., Binkley P., Buchele D., Anand I., Swingen C., Di Carli M. F., Thomas J. D., Jaber W. A., Opie S. R., Campbell A., McCarthy P., Yeager M., Dilsizian V., Griffith B. P., Korn R., Kreuger S. K., Ghazoul M., MacLellan W. R., Fonarow G., Eisen H. J., Dinsmore J., Diethrich E., Safety and feasibility of autologous myoblast transplantation in patients with ischemic cardiomyopathy: four-year follow-up Circulation 2005 112 12 1748 1755 (Pubitemid 41368151)
23. Assmus B., Honold J., Schchinger V., Britten M. B., Fischer-Rasokat U., Lehmann R., Teupe C., Pistorius K., Martin H., Abolmaali N. D., Tonn T., Dimmeler S., Zeiher A. M., Transcoronary transplantation of progenitor cells after myocardial infarction New England Journal of Medicine 2006 355 12 1222 1232 (Pubitemid 44427446)
24. Losordo D. W., Schatz R. A., White C. J., Udelson J. E., Veereshwarayya V., Durgin M., Poh K. K., Weinstein R., Kearney M., Chaudhry M., Burg A., Eaton L., Heyd L., Thorne T., Shturman L., Hoffmeister P., Story K., Zak V., Dowling D., Traverse J. H., Olson R. E., Flanagan J., Sodano D., Murayama T., Kawamoto A., Kusano K. F., Wollins J., Welt F., Shah P., Soukas P., Asahara T., Henry T. D., Intramyocardial transplantation of autologous CD34 + stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial Circulation 2007 115 25 3165 3172 (Pubitemid 47018140)
25. Tse H.-F., Thambar S., Kwong Y.-L., Rowlings P., Bellamy G., McCrohon J., Thomas P., Bastian B., Chan J. K. F., Lo G., Ho C.-L., Chan W.-S., Kwong R. Y., Parker A., Hauser T. H., Chan J., Fong D. Y. T., Lau C.-P., Prospective randomized trial of direct endomyocardial implantation of bone marrow cells for treatment of severe coronary artery diseases (PROTECT-CAD trial) European Heart Journal 2007 28 24 2998 3005 (Pubitemid 350262782)
26. Van Ramshorst J., Bax J. J., Beeres S. L. M. A., Dibbets-Schneider P., Roes S. D., Stokkel M. P. M., De Roos A., Fibbe W. E., Zwaginga J. J., Boersma E., Schalij M. J., Atsma D. E., Intramyocardial bone marrow cell injection for chronic myocardial ischemia: a randomized controlled trial Journal of the American Medical Association 2009 301 19 1997 2004
27. Lo B., Kriegstein A., Grady D., Clinical trials in stem cell transplantation: guidelines for scientific and ethical review Clinical Trials 2008 5 5 517 522
28. Valgimigli M., Rigolin G. M., Cittanti C., Malagutti P., Curello S., Percoco G., Bugli A. M., Della Porta M., Bragotti L. Z., Ansani L., Mauro E., Lanfranchi A., Giganti M., Feggi L., Castoldi G., Ferrari R., Use of granulocyte-colony stimulating factor during acute myocardial infarction to enhance bone marrow stem cell mobilization in humans: clinical and angiographic safety profile European Heart Journal 2005 26 18 1838 1845 (Pubitemid 41253295)
29. Zohlnhfer D., Ott I., Mehilli J., Schmig K., Michalk F., Ibrahim T., Meisetschlger G., Von Wedel J., Bollwein H., Seyfarth M., Dirschinger J., Schmitt C., Schwaiger M., Kastrati A., Schmig A., Stem cell mobilization by granulocyte colony-stimulating factor in patients with acute myocardial infarction: a randomized controlled trial Journal of the American Medical Association 2006 295 9 1003 1010
30. Ripa R. S., Jrgensen E., Wang Y., Thune J. J., Nilsson J. C., Sndergaard L., Johnsen H. E., Kber L., Grande P., Kastrup J., Stem cell mobilization induced by subcutaneous granulocyte-colony stimulating factor to improve cardiac regeneration after acute ST-elevation myocardial infarction: result of the double-blind, randomized, placebo-controlled stem cells in myocardial infarction (STEMMI) trial Circulation 2006 113 16 1983 1992
31. Engelmann M. G., Theiss H. D., Hennig-Theiss C., Autologous bone marrow stem cell mobilization induced by granulocyte colony-stimulating factor after subacute ST-segment elevation myocardial infarction undergoing late revascularization: final results from the G-CSF-STEMI (Granulocyte Colony-Stimulating Factor ST-Segment Elevation Myocardial Infarction) trial Journal of the American College of Cardiology 2006 48 8 1712 1721 (Pubitemid 44528196)
32. Ellis S. G., Penn M. S., Bolwell B., Garcia M., Chacko M., Wang T., Brezina K. J., McConnell G., Topol E. J., Granulocyte colony stimulating factor in patients with large acute myocardial infarction: results of a pilot dose-escalation randomized trial American Heart Journal 2006 152 6 1051.e9 1051.e14
33. Lindsey M. L., Mann D. L., Entman M. L., Spinale F. G., Extracellular matrix remodeling following myocardial injury Annals of Medicine 2003 35 5 316 326 (Pubitemid 37013672)
34. Dewald O., Ren G., Duerr G. D., Zoerlein M., Klemm C., Gersch C., Tincey S., Michael L. H., Entman M. L., Frangogiannis N. G., Of mice and dogs: species-specific differences in the inflammatory response following myocardial infarction American Journal of Pathology 2004 164 2 665 677 (Pubitemid 38364680)
35. Cho H.-J., Lee N., Ji Y. L., Yong J. C., Ii M., Wecker A., Jeong J.-O., Curry C., Qin G., Yoon Y.-S., Role of host tissues for sustained humoral effects after endothelial progenitor cell transplantation into the ischemic heart Journal of Experimental Medicine 2007 204 13 3257 3269
36. Mazhari R., Hare J. M., Mechanisms of action of mesenchymal stem cells in cardiac repair: potential influences on the cardiac stem cell niche Nature Clinical Practice Cardiovascular Medicine 2007 4 supplement 1 S21 S26
37. Gnecchi M., Zhang Z., Ni A., Dzau V. J., Paracrine mechanisms in adult stem cell signaling and therapy Circulation Research 2008 103 11 1204 1219
38. San Romn J. A., Candell-Riera J., Arnold R., Snchez P. L., Aguadé-Bruix S., Bermejo J., Revilla A., Villa A., Cuéllar H., Hernndez C., Fernndez-Avilés F., Quantitative analysis of left ventricular function as a tool in clinical research. Theoretical basis and methodology Revista Espanola de Cardiologia 2009 62 5 535 551
39. Yousef M., Schannwell C. M., Kstering M., Zeus T., Brehm M., Strauer B. E., The BALANCE Study: clinical benefit and long-term outcome after intracoronary autologous bone marrow cell transplantation in patients with acute myocardial infarction Journal of the American College of Cardiology 2009 53 24 2262 2269
40. Fuster V., Sanz J., Viles-Gonzalez J. F., Rajagopalan S., The utility of magnetic resonance imaging in cardiac tissue regeneration trials Nature Clinical Practice Cardiovascular Medicine 2006 3 supplement 1 S2 S7
41. San Romn J. A., Fernndez-Avilés F., The role of noninvasive imaging techniques in the assessment of stem cell therapy after acute myocardial infarction Nature Clinical Practice Cardiovascular Medicine 2006 3 supplement 1 S38 S41
42. George J. C., Stem cell therapy in acute myocardial infarction: a review of clinical trials Translational Research 2010 155 1 10 19
43. Bartunek J., Dimmeler S., Drexler H., Fernndez-Avilés F., Galinanes M., Janssens S., Martin J., Mathur A., Menasche P., Priori S., Strauer B., Tendera M., Wijns W., Zeiher A., 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 European Heart Journal 2006 27 11 1338 1340 (Pubitemid 43998109)
44. Takahashi K., Tanabe K., Ohnuki M., Narita M., Ichisaka T., Tomoda K., Yamanaka S., Induction of pluripotent stem cells from adult human fibroblasts by defined factors Cell 2007 131 5 861 872 (Pubitemid 350138099)
45. Yu J., Vodyanik M. A., Smuga-Otto K., Antosiewicz-Bourget J., Frane J. L., Tian S., Nie J., Jonsdottir G. A., Ruotti V., Stewart R., Slukvin I. I., Thomson J. A., Induced pluripotent stem cell lines derived from human somatic cells Science 2007 318 5858 1917 1920
46. Ott H. C., Matthiesen T. S., Goh S.-K., Black L. D., Kren S. M., Netoff T. I., Taylor D. A., Perfusion-decellularized matrix: using nature's platform to engineer a bioartificial heart Nature Medicine 2008 14 2 213 221 (Pubitemid 351214548)