Deliverables
First patient treated.
Production of IMP for clinical trial final.
Clinical Trial Kick-off meeting with all clinical partners.
Arrangements for an international scientific workshop on stem cell-based treatment of cardiac disease.
Monitoring of clinical sites.
Report on the status of the posting of results (to the study registry).
Training logs for personnel complete
A clinically applicable technique to determine and quantify cardiac fibrosis by MRI
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: Using country comparisons results and refinement of methods, a conclusive assessment of the economic effects of ASC therapy can be given.
Validation of a novel treatment planning tool for cardiac cell therapy, that is based on real time image integration
IP management final.
Dissemination to relevant groups and meetings. Production technology published in peer reviewed journal. Clinical trial design published in peer reviewed journal.
First preliminary results of health economics: Standard cost-effectiveness analysis of ASC therapy for each country involved, analysis of country differences
All approvals from national ethics committees and national competent authorities of all study sites recieved.
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
Documentation of proper classification for sterile GMP production.
Production ready to start.
IWRS, eCRF and database developed
Establishment of SCIENCE website for public and partner use.
Publications
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
DOI: 10.1002/sctm.17-0040
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
DOI: 10.20452/pamw.3644
Author(s): Jozef Bartunek, Wojtek Wojakowski
Published in: European Heart Journal, Issue 38/39, 2017, Page(s) 2944-2947, ISSN 0195-668X
DOI: 10.1093/eurheartj/ehx300
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
DOI: 10.1155/2017/8506370
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
DOI: 10.1161/circresaha.115.307347
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
DOI: 10.1093/eurheartj/ehx248
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
DOI: 10.1080/00365513.2018.1462082
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
DOI: 10.1080/00365513.2017.1354258
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
DOI: 10.1002/ejhf.1412
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
DOI: 10.1016/j.jcyt.2016.09.006
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
DOI: 10.1161/circresaha.117.312099
Author(s): Mandana Haack-Sørensen, Annette Ekblond, Jens Kastrup
Published in: Mesenchymal Stem Cells - Methods and Protocols, Issue 1416, 2016, Page(s) 357-374
DOI: 10.1007/978-1-4939-3584-0_21