Rezultaty
First patient treated.
IMP production finalProduction of IMP for clinical trial final.
Clinical trial kick-offClinical Trial Kick-off meeting with all clinical partners.
International workshopArrangements for an international scientific workshop on stem cell-based treatment of cardiac disease.
Monitoring of clinical sites.
Status on posting of resultsReport on the status of the posting of results (to the study registry).
Training logsTraining logs for personnel complete
Quantification of cardiac fibrosisA clinically applicable technique to determine and quantify cardiac fibrosis by MRI
Determination of local deformation parametersEasy 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 effectivenessComprehensive 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 therapyValidation of a novel treatment planning tool for cardiac cell therapy, that is based on real time image integration
IP managementIP management final.
DisseminationDissemination to relevant groups and meetings. Production technology published in peer reviewed journal. Clinical trial design published in peer reviewed journal.
Preliminary cost-effectiveness analysisFirst preliminary results of health economics: Standard cost-effectiveness analysis of ASC therapy for each country involved, analysis of country differences
All approvals packageAll approvals from national ethics committees and national competent authorities of all study sites recieved.
Method for a financial analysisDeveloped 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 facilityDocumentation of proper classification for sterile GMP production.
Production ready to start.
Clinical databasesIWRS, eCRF and database developed
Establishment of SCIENCE website for public and partner use.
Publikacje
Autorzy:
Jozef Bartunek, Wojtek Wojakowski
Opublikowane w:
European Heart Journal, Numer 38/39, 2017, Strona(/y) 2944-2947, ISSN 0195-668X
Wydawca:
Oxford University Press
DOI:
10.1093/eurheartj/ehx300
Autorzy:
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
Opublikowane w:
European Heart Journal, Numer 38/33, 2017, Strona(/y) 2532-2546, ISSN 0195-668X
Wydawca:
Oxford University Press
DOI:
10.1093/eurheartj/ehx248
Autorzy:
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
Opublikowane w:
European Journal of Heart Failure, 2019, ISSN 1388-9842
Wydawca:
Elsevier BV
DOI:
10.1002/ejhf.1412
Autorzy:
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
Opublikowane w:
Circulation Research, Numer 122/2, 2018, Strona(/y) 199-201, ISSN 0009-7330
Wydawca:
Lippincott Williams & Wilkins Ltd.
DOI:
10.1161/circresaha.117.312099
Prawa własności intelektualnej
Numer wniosku/publikacji:
20
16075407
Data:
2016-10-21
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