Deliverables Other (4) First patient treated First patient treated. IMP production final Production of IMP for clinical trial final. Clinical trial kick-off Clinical Trial Kick-off meeting with all clinical partners. International workshop Arrangements for an international scientific workshop on stem cell-based treatment of cardiac disease. Documents, reports (13) Monitoring of clinical sites Monitoring of clinical sites. Status on posting of results Report on the status of the posting of results (to the study registry). Training logs Training logs for personnel complete Quantification of cardiac fibrosis A clinically applicable technique to determine and quantify cardiac fibrosis by MRI Determination of local deformation parameters Easy to use protocol for 3D echocardiography to determine local deformation parameters. Use the local myocardial deformation to assess the local effects of cardiac regenerative therapy on local cardiac function Comprehensive cost-PU effectiveness Comprehensive cost-PU effectiveness: Using country comparisons results and refinement of methods, a conclusive assessment of the economic effects of ASC therapy can be given. Planning tool for cardiac cell therapy Validation of a novel treatment planning tool for cardiac cell therapy, that is based on real time image integration IP management IP management final. Dissemination Dissemination to relevant groups and meetings. Production technology published in peer reviewed journal. Clinical trial design published in peer reviewed journal. Preliminary cost-effectiveness analysis First preliminary results of health economics: Standard cost-effectiveness analysis of ASC therapy for each country involved, analysis of country differences All approvals package All approvals from national ethics committees and national competent authorities of all study sites recieved. Method for a financial analysis Developed tools: A methodology for a financial analysis of innovative medical technology will be set up comprising a software tool to be used on the spot by the developers of the technologies Qualification of production facility Documentation of proper classification for sterile GMP production. Demonstrators, pilots, prototypes (2) Production initiated Production ready to start. Clinical databases IWRS, eCRF and database developed Websites, patent fillings, videos etc. (1) Website Establishment of SCIENCE website for public and partner use. Publications Peer reviewed articles (11) Cryopreserved Off-the-Shelf Allogeneic Adipose-Derived Stromal Cells for Therapy in Patients with Ischemic Heart Disease and Heart Failure-A Safety Study Author(s): Jens Kastrup, Mandana Haack-Sørensen, Morten Juhl, Rebekka Harary Søndergaard, Bjarke Follin, Lisbeth Drozd Lund, Ellen Mønsted Johansen, Abbas Ali Qayyum, Anders Bruun Mathiasen, Erik Jørgensen, Steffen Helqvist, Jens Jørgen Elberg, Helle Bruunsgaard, Annette Ekblond Published in: STEM CELLS Translational Medicine, Issue 6/11, 2017, Page(s) 1963-1971, ISSN 2157-6564 Publisher: AlphaMed Press DOI: 10.1002/sctm.17-0040 Stem cells and clinical practice: new advances and challenges at the time of emerging problems with induced pluripotent stem cell therapies Author(s): Mariusz Z. Ratajczak, Kamila Bujko, Wojciech Wojakowski Published in: Polish Archives of Internal Medicine, Issue 126/11, 2016, Page(s) 879-890, ISSN 1897-9483 Publisher: Medycyna Praktyczna DOI: 10.20452/pamw.3644 Intracoronary autologous bone marrow cell transfer after acute myocardial infarction: abort and refocus Author(s): Jozef Bartunek, Wojtek Wojakowski Published in: European Heart Journal, Issue 38/39, 2017, Page(s) 2944-2947, ISSN 0195-668X Publisher: Oxford University Press DOI: 10.1093/eurheartj/ehx300 Rationale and Design of the First Double-Blind, Placebo-Controlled Trial with Allogeneic Adipose Tissue-Derived Stromal Cell Therapy in Patients with Ischemic Heart Failure: A Phase II Danish Multicentre Study Author(s): Jens Kastrup, Morten Schou, Ida Gustafsson, Olav W. Nielsen, Rasmus Møgelvang, Klaus F. Kofoed, Charlotte Kragelund, Jens Dahlgaard Hove, Andreas Fabricius-Bjerre, Merete Heitman, Mandana Haack-Sørensen, Lisbeth Drozd Lund, Ellen Mønsted Johansen, Abbas Ali Qayyum, Anders Bruun Mathiasen, Annette Ekblond Published in: Stem Cells International, Issue 2017, 2017, Page(s) 1-8, ISSN 1687-966X Publisher: Hindawi DOI: 10.1155/2017/8506370 Meta-Analyses of Human Cell-Based Cardiac Regeneration Therapies Author(s): Mariann Gyöngyösi, Wojciech Wojakowski, Eliano P. Navarese, Lemuel À. Moye Published in: Circulation Research, Issue 118/8, 2016, Page(s) 1254-1263, ISSN 0009-7330 Publisher: Lippincott Williams & Wilkins Ltd. DOI: 10.1161/circresaha.115.307347 Global position paper on cardiovascular regenerative medicine Author(s): Francisco Fernández-Avilés, Ricardo Sanz-Ruiz, Andreu M. Climent, Lina Badimon, Roberto Bolli, Dominique Charron, Valentin Fuster, Stefan Janssens, Jens Kastrup, Hyo-Soo Kim, Thomas F. Lüscher, John F. Martin, Philippe Menasché, Robert D. Simari, Gregg W. Stone, Andre Terzic, James T. Willerson, Joseph C. Wu, Francisco Fernández-Avilés, Andre Terzic, Lina Badimon, Kathleen Broughton, Darcy L Published in: European Heart Journal, Issue 38/33, 2017, Page(s) 2532-2546, ISSN 0195-668X Publisher: Oxford University Press DOI: 10.1093/eurheartj/ehx248 Development of large-scale manufacturing of adipose-derived stromal cells for clinical applications using bioreactors and human platelet lysate Author(s): Mandana Haack-Sørensen, Morten Juhl, Bjarke Follin, Rebekka Harary Søndergaard, Maria Kirchhoff, Jens Kastrup, Annette Ekblond Published in: Scandinavian Journal of Clinical and Laboratory Investigation, Issue 78/4, 2018, Page(s) 293-300, ISSN 0036-5513 Publisher: Taylor & Francis DOI: 10.1080/00365513.2018.1462082 Influence of patient related factors on number of mesenchymal stromal cells reached after in vitro culture expansion for clinical treatment Author(s): Abbas Ali Qayyum, Kamal Preet Kaur, Anders Bruun Mathiasen, Mandana Haack-Sørensen, Annette Ekblond, Jens Kastrup Published in: Scandinavian Journal of Clinical and Laboratory Investigation, Issue 77/7, 2017, Page(s) 541-548, ISSN 0036-5513 Publisher: Taylor & Francis DOI: 10.1080/00365513.2017.1354258 Rationale and design of the European multicentre study on Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE) Author(s): Christina Paitazoglou, Martin W. Bergmann, Bojan Vrtovec, Steven A.J. Chamuleau, Bas van Klarenbosch, Wojtek Wojakowski, Aleksandra Michalewska-Włudarczyk, Mariann Gyöngyösi, Annette Ekblond, Mandana Haack-Sørensen, Kai Jaquet, Karsten Vrangbaek, Jens Kastrup Published in: European Journal of Heart Failure, 2019, ISSN 1388-9842 Publisher: Elsevier BV DOI: 10.1002/ejhf.1412 Senescence and quiescence in adipose-derived stromal cells: Effects of human platelet lysate, fetal bovine serum and hypoxia Author(s): Rebekka Harary Søndergaard, Bjarke Follin, Lisbeth Drozd Lund, Morten Juhl, Annette Ekblond, Jens Kastrup, Mandana Haack-Sørensen Published in: Cytotherapy, Issue 19/1, 2017, Page(s) 95-106, ISSN 1465-3249 Publisher: Taylor & Francis DOI: 10.1016/j.jcyt.2016.09.006 Global Overview of the Transnational Alliance for Regenerative Therapies in Cardiovascular Syndromes (TACTICS) Recommendations Author(s): Francisco Fernández-Avilés, Ricardo Sanz-Ruiz, Andreu M. Climent, Lina Badimon, Roberto Bolli, Dominique Charron, Valentin Fuster, Stefan Janssens, Jens Kastrup, Hyo-Soo Kim, Thomas F. Lüscher, John F. Martin, Philippe Menasché, Fausto J. Pinto, Robert D. Simari, Gregg W. Stone, Andre Terzic, James T. Willerson, Joseph C. Wu Published in: Circulation Research, Issue 122/2, 2018, Page(s) 199-201, ISSN 0009-7330 Publisher: Lippincott Williams & Wilkins Ltd. DOI: 10.1161/circresaha.117.312099 Book chapters (1) Cryopreservation and Revival of Human Mesenchymal Stromal Cells Author(s): Mandana Haack-Sørensen, Annette Ekblond, Jens Kastrup Published in: Mesenchymal Stem Cells - Methods and Protocols, Issue 1416, 2016, Page(s) 357-374, ISBN 978-1-4939-3582-6 Publisher: Springer New York DOI: 10.1007/978-1-4939-3584-0_21 Searching for OpenAIRE data... There was an error trying to search data from OpenAIRE No results available
