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HIPGEN SIGNED

Placenta-expanded adherent stromal cells (PLX-PAD) as an innovative therapy for improving recovery and survival following hip fracture arthroplasty – HIPGEN, a multicenter phase III trial

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

HIPGEN project word cloud

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

reactions plx efficacy stress combined mortality elderly mechanisms create placebo imposed trial iof hip stromal action first incidence strategic volume injured immunology immobilisation cell biomechanical intramuscular organisation medical effect stratifying intraoperative renown demonstrated regeneration individual preclinical osteoporosis therapy disseminate platform plan fractures recovery experts surgery health analysing conventional mobility cells injections charit clinicians postoperative pad arthroplasty randomised direct functional million aim clinical pluristem conduct indirect force communicate public eacute immune allogeneic atmp patients hipgen placental biomarker double characterisation fracture indication engagement patient impairment medicinal blind therapies injury multicentre muscle

Project "HIPGEN" data sheet

The following table provides information about the project.

Coordinator	CHARITE - UNIVERSITAETSMEDIZIN BERLIN Organization address address: Chariteplatz 1 city: BERLIN postcode: 10117 website: www.charite.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.hipgen.eu/
Total cost	7˙437˙127 €
EC max contribution	7˙437˙127 € (100%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-SC1-2017-Single-Stage-RTD
Funding Scheme	RIA
Starting year	2018
Duration (year-month-day)	from 2018-01-01 to 2021-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	CHARITE - UNIVERSITAETSMEDIZIN BERLIN CHARITE - UNIVERSITAETSMEDIZIN BERLIN Organization address address: Chariteplatz 1 city: BERLIN postcode: 10117 website: www.charite.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 (BERLIN)	coordinator	1˙715˙512.00
2	PLURISTEM LTD PLURISTEM LTD Organization address address: MATAM INDUSTRIAL PARK BLDG 20 city: HAIFA postcode: 31905 website: http://www.pluristem.com/index.asp contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IL (HAIFA)	participant	2˙610˙575.00
3	ICON CLINICAL RESEARCH LIMITED ICON CLINICAL RESEARCH LIMITED Organization address address: SOUTH COUNTY BUSINESS PARK LEOPARDSTOWN city: DUBLIN postcode: 18 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.	IE (DUBLIN)	participant	1˙250˙000.00
4	BE THE PARTNER INC BE THE PARTNER INC Organization address address: 1506 BOSTON PROVIDENCE HIGHWAY SUITE 29A city: NORWOOD MA postcode: 2062 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.	US (NORWOOD MA)	participant	440˙275.00
5	ODENSE UNIVERSITETSHOSPITAL ODENSE UNIVERSITETSHOSPITAL Organization address address: Sdr. Boulevard 29 city: ODENSE postcode: 5000 website: www.ouh.dk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (ODENSE)	participant	415˙250.00
6	FONDAZIONE POLIAMBULANZA FONDAZIONE POLIAMBULANZA Organization address address: VIA BISSOLATI 57 city: BRESCIA postcode: 25124 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.	IT (BRESCIA)	participant	340˙575.00
7	ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU Organization address address: VIA FIORENTINA 151 city: SIENA postcode: 53100 website: www.altaweb.eu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (SIENA)	participant	260˙600.00
8	THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD Organization address address: WELLINGTON SQUARE UNIVERSITY OFFICES city: OXFORD postcode: OX1 2JD website: www.ox.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 (OXFORD)	participant	229˙502.00
9	INTERNATIONAL OSTEOPOROSIS FOUNDATION INTERNATIONAL OSTEOPOROSIS FOUNDATION Organization address address: RUE JUSTE OLIVIER 9 city: NYON postcode: 1260 website: http://www.iofbonehealth.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (NYON)	participant	100˙025.00
10	OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST Organization address address: HEADLEY WAY THE JOHN RADCLIFFE HOSPITAL city: HEADINGTON postcode: OX39DU website: http://www.oxfordradcliffe.nhs.uk/home.aspx contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (HEADINGTON)	participant	74˙812.00
11	BE THE PARTNER AG BE THE PARTNER AG Organization address address: AM KARLSBAD 15 city: BERLIN postcode: 10785 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 (BERLIN)	participant	0.00

Map

Project objective

Aim of the HIPGEN project is to develop the first cell therapy to improve functional recovery following hip fracture arthroplasty. Hip fractures are a major public health concern in the EU with an increasing incidence of 1 million patients per year, high direct and indirect costs and high mortality. Conventional therapies are not able to address the main medical problems of hip fracture in these elderly patients, being the impairment of mobility and the stress imposed as a combined result of injury, surgery and immobilisation. PLX-PAD are an allogeneic, placental-derived, stromal cell product and currently the only Advanced Therapy Medicinal Product (ATMP) in phase III in this indication. Based on comprehensive preclinical work on the effect of PLX-PAD on muscle regeneration after injury, a phase I/II study under the collaboration of Pluristem and Charité demonstrated an increase in muscle force and volume in hip arthroplasty patients and a reduction of early postoperative stress. We plan to conduct a multicentre, randomised, double blind, placebo controlled phase III clinical trial evaluating the efficacy of intraoperative intramuscular injections of PLX-PAD for the recovery of hip fracture patients. The clinical study will include biomechanical analyses and in-depth biomarker studies of treated patients analysing the effects of the cells on the immune system and individual stress reactions aiming at stratifying patients in future therapies. Further preclinical characterisation of the mechanisms of action of PLX-PAD in injured patients will be conducted. The “Be the Partner” platform will be used to improve patient experience in the trial, and create a strategic patient engagement beyond the trial. In addition to renown experts in hip fracture, cell therapy and immunology, our consortium includes the main organisation for osteoporosis, IOF, who will help disseminate and communicate the results of the phase III study among clinicians and patient organisations.

Deliverables

List of deliverables.
Project web site	Websites, patent fillings, videos etc.	2020-04-16 10:13:22
Initial dissemination plan	Documents, reports	2020-04-16 10:13:22
Project visual identity	Websites, patent fillings, videos etc.	2020-04-16 10:13:22

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

Publications

List of publications.
year	authors and title	journal	last update
2019	Guido Moll, James A. Ankrum, Julian Kamhieh-Milz, Karen Bieback, Olle RingdÃ©n, Hans-Dieter Volk, Sven Geissler, Petra Reinke Intravascular Mesenchymal Stromal/Stem Cell Therapy Product Diversification: Time for New Clinical Guidelines published pages: 149-163, ISSN: 1471-4914, DOI: 10.1016/j.molmed.2018.12.006	Trends in Molecular Medicine 25/2	2020-04-16
2018	Oliver Klein, Kristin Strohschein, Grit Nebrich, Michael Fuchs, Herbert Thiele, Patrick Giavalisco, Georg N. Duda, Tobias Winkler, Jan Hendrik Kobarg, Dennis Trede, Sven Geissler Unraveling local tissue changes within severely injured skeletal muscles in response to MSC-based intervention using MALDI Imaging mass spectrometry published pages: , ISSN: 2045-2322, DOI: 10.1038/s41598-018-30990-w	Scientific Reports 8/1	2020-04-16
2018	Tobias Winkler, Carsten Perka, Philipp von Roth, Alison N. Agres, Henning Plage, Bernd Preininger, Matthias Pumberger, Sven Geissler, Esther Lukasiewicz Hagai, Racheli Ofir, Lena Pinzur, Eli Eyal, Gisela Stoltenburg-Didinger, Christian Meisel, Christine Consentius, Mathias Streitz, Petra Reinke, Georg N. Duda, Hans-Dieter Volk Immunomodulatory placental-expanded, mesenchymal stromal cells improve muscle function following hip arthroplasty published pages: 880-897, ISSN: 2190-5991, DOI: 10.1002/jcsm.12316	Journal of Cachexia, Sarcopenia and Muscle 9/5	2020-04-16
2019	Antonietta R. Silini, Alice Masserdotti, Andrea Papait, Ornella Parolini Shaping the Future of Perinatal Cells: Lessons From the Past and Interpretations of the Present published pages: 1-7, ISSN: 2296-4185, DOI: 10.3389/fbioe.2019.00075	Frontiers in Bioengineering and Biotechnology 7	2020-04-16
2019	Taimoor H. Qazi, Georg N. Duda, Melanie J. Ort, Carsten Perka, Sven Geissler, Tobias Winkler Cell therapy to improve regeneration of skeletal muscle injuries published pages: 501-516, ISSN: 2190-5991, DOI: 10.1002/jcsm.12416	Journal of Cachexia, Sarcopenia and Muscle 10/3	2020-04-16

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

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