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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 €

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EC-Contrib. €

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Partnership

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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 DE (BERLIN) coordinator 1˙715˙512.00
2    PLURISTEM LTD IL (HAIFA) participant 2˙610˙575.00
3    ICON CLINICAL RESEARCH LIMITED IE (DUBLIN) participant 1˙250˙000.00
4    BE THE PARTNER INC US (NORWOOD MA) participant 440˙275.00
5    ODENSE UNIVERSITETSHOSPITAL DK (ODENSE) participant 415˙250.00
6    FONDAZIONE POLIAMBULANZA IT (BRESCIA) participant 340˙575.00
7    ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU IT (SIENA) participant 260˙600.00
8    THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD UK (OXFORD) participant 229˙502.00
9    INTERNATIONAL OSTEOPOROSIS FOUNDATION CH (NYON) participant 100˙025.00
10    OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST UK (HEADINGTON) participant 74˙812.00
11    BE THE PARTNER AG 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

year authors and title journal last update
List of publications.
2019 Guido Moll, James A. Ankrum, Julian Kamhieh-Milz, Karen Bieback, Olle Ringdén, 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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