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HemAcure SIGNED

Application of combined gene and cell therapy within an implantable therapeutic device for the treatment of severe hemophilia A

Total Cost €

EC-Contrib. €

Partnership

Views

Outcomes and
results

HemAcure project word cloud

Explore the words cloud of the HemAcure project. It provides you a very rough idea of what is the project "HemAcure" about.

viii prevent led risk manipulation appropriate therapy cell passage therapeutic patient treat mutations medicyte worldwide monitoring patients medical maximizing implantation quality repair refine bleeding animal blood disease prepared hemophilia defect systematic copy gmp reliver beginning haemophilia comply fp7 manufacturability fviii tools deficiency isolation gene efficacy genetic profile balance life culture ultimately involve respect safety caused relates minimizing designed adapting hemacure proof models cells bioreactor device clear risks regulations introducing correct refinement expansion goals ex acceptable vivo automation clotting technologies scalable

Project "HemAcure" data sheet

The following table provides information about the project.

Coordinator	UNIVERSITAETSKLINIKUM WUERZBURG - KLINIKUM DER BAYERISCHEN JULIUS-MAXIMILIANS-UNIVERSITAT Organization address address: JOSEF-SCHNEIDER-STRASSE 2 city: WURZBURG postcode: 97080 website: www.uk-wuerzburg.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Germany [DE]
Project website	https://www.hemacure.eu/
Total cost	5˙564˙395 €
EC max contribution	5˙564˙395 € (100%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-PHC-2015-two-stage
Funding Scheme	RIA
Starting year	2015
Duration (year-month-day)	from 2015-11-01 to 2018-10-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	UNIVERSITAETSKLINIKUM WUERZBURG - KLINIKUM DER BAYERISCHEN JULIUS-MAXIMILIANS-UNIVERSITAT UNIVERSITAETSKLINIKUM WUERZBURG - KLINIKUM DER BAYERISCHEN JULIUS-MAXIMILIANS-UNIVERSITAT Organization address address: JOSEF-SCHNEIDER-STRASSE 2 city: WURZBURG postcode: 97080 website: www.uk-wuerzburg.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (WURZBURG)	coordinator	1˙714˙513.00
2	UNIVERSITA DEGLI STUDI DEL PIEMONTE ORIENTALE AMEDEO AVOGADRO UNIVERSITA DEGLI STUDI DEL PIEMONTE ORIENTALE AMEDEO AVOGADRO Organization address address: DUOMO 6 city: VERCELLI postcode: 13100 website: www.unipmn.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (VERCELLI)	participant	1˙400˙000.00
3	LOUGHBOROUGH UNIVERSITY LOUGHBOROUGH UNIVERSITY Organization address address: ASHBY ROAD city: LOUGHBOROUGH postcode: LE11 3TU website: www.lboro.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LOUGHBOROUGH)	participant	983˙280.00
4	SERNOVA CORP. SERNOVA CORP. Organization address address: 700 COLLIP CIRCLE SUITE 114 city: LONDON ONTARIO postcode: N6G4X8 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CA (LONDON ONTARIO)	participant	944˙177.00
5	GRUNEWALD JURGEN GRUNEWALD JURGEN Organization address address: KETTELERSTRASSE 30 city: HEPPENHEIM postcode: 64646 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HEPPENHEIM)	participant	179˙845.00
6	GRUNEWALD VERWALTUNGS GMBH GRUNEWALD VERWALTUNGS GMBH Organization address address: SPESSARTSTRASSE 2 city: HEPPENHEIM postcode: 64646 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HEPPENHEIM)	participant	158˙342.00
7	ARTTIC ARTTIC Organization address address: RUE DU DESSOUS DES BERGES 58A city: PARIS postcode: 75013 website: www.arttic.eu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	150˙000.00
8	GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG Organization address address: OSKAR VON MILLER RING 29 city: MUENCHEN postcode: 80333 website: www.gabo-mi.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (MUENCHEN)	participant	34˙237.00

Map

Project objective

The main objective of the HemAcure project is to develop and refine the tools and technologies for a novel ex vivo prepared cell based therapy to treat the bleeding disease haemophilia A (caused by genetic deficiency in clotting factor VIII (FVIII)) that should ultimately lead to improved quality of life of the patients. The concept is a further development of our approach, established during the FP7 ReLiver project led by Medicyte. From the very beginning, we balance two important goals, maximizing the product’s efficacy and safety profile on one side and minimizing production cost on the other by enhancing the product’s manufacturability. HemAcure relates to the work program as we focus on the refinement of all steps and tools of our ex vivo gene therapy approach. These steps involve 1) isolation and culture of cells from patients’ blood, 2) manipulation of patient cells to repair its genetic defect by ex vivo introducing the correct genetic copy of FVIII (mutations in this gene lead to hemophilia A), 3) automation of cell expansion in a novel and passage-less scalable bioreactor, 4) continuously monitoring of cells during and after expansion with respect to their safety profile and functionality, 5) cell implantation into a worldwide unique medical device for targeted delivery of therapeutic Factor VIII and 6) proof-of-concept and safety studies in appropriate haemophilia A animal models. The aim of adapting the proof-of-concept to GMP requires a risk based approach, by means of a clear understanding of the whole process from design to production of the therapeutic cells and a systematic way to identify and prevent risks that are not acceptable for the patient. All steps will be designed and conducted according to European GMP-regulations to ensure that the product will fully comply to the requirements for quality of the European authorities.

Deliverables

List of deliverables.
Final dissemination activity on project results	Other	2019-08-30 14:16:29
Exploitation activity (as above)	Documents, reports	2019-08-30 14:16:29
Launch of website, Twitter, Facebook, LinkedIn etc.	Websites, patent fillings, videos etc.	2019-08-30 14:16:29
Individualized press release for every partner	Documents, reports	2019-08-30 14:16:29

Take a look to the deliverables list in detail: detailed list of HemAcure deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2017	Patrick Bittorf, Martin Zierau, Ralf Sanzenbacher, Heike Walles, Joris Braspenning Combined ATMPs Containing Genetically Modified Cells published pages: 168-174, ISSN: , DOI:	Pharmazeutische Medizin	2019-08-30
2017	Chiara Borsotti, Simone Merlin, Cristina Olgasi, Thorsten Bergmann, Delfina M. Mazzuca, Alexandra Stolzing, Martin Zierau, Philip M. Toleikis, Joris Braspenning and Antonia Follenzi Application of combined gene and cell therapy within an implantabletherapeutic device for the treatment of severe haemophilia A published pages: s483, ISSN: 1723-2007, DOI:	Blood Transfusion Vol.15, Supplement No. 3, Septe	2019-08-30
2018	Miguel Rodrigues \"\"\"Use of BOECs for therapeutic applications\"\"\" published pages: , ISSN: , DOI:		2019-08-30
2017	Cristina Olgasi, Simone Merlin, Thorsten Bergmann, Chiara Borsotti, Delfina M. Mazzuca, Alexandra Stolzing, Martin Zierau, Philip M. Toleikis, Joris Braspenning and Antonia Follenzi Application of combined gene and cell therapy within an implantabletherapeutic device for the treatment of severe haemophilia A (poster presentation at ESGCT congress, Berlin, 2017) published pages: pp A92, ISSN: 1043-0342, DOI:	Human Gene Therapy Vol.28, No. 12, 1st December 20	2019-08-30
2019	Patrick Bittorf Genetically modified cells for treatment of heamophilia A published pages: , ISSN: , DOI:		2019-08-30
2018	C Olgasi, S Merlin, C Borsotti, T Bergmann, D M Mazzucca, A Stolzing, M Zierau, P M Toleikis, J Braspenning, A Follenzi Â Application of combined gene and cell therapy within an implantable therapeutic device for the treatment of severe haemophilia A published pages: , ISSN: , DOI:	ESGCT abstract book 2018 16th-19th October 2018	2019-08-30

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The information about "HEMACURE" are provided by the European Opendata Portal: CORDIS opendata.