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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

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.

Call for proposal

H2020-SC1-2016-2017

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Sub call

H2020-SC1-2017-Single-Stage-RTD

Coordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Net EU contribution
€ 1 750 387,50
Address
Chariteplatz 1
10117 Berlin
Germany

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Region
Berlin Berlin Berlin
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00

Participants (16)

THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
Net EU contribution
€ 244 502,50
Address
Wellington Square University Offices
OX1 2JD Oxford

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Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
REGION SYDDANMARK
Denmark
Net EU contribution
€ 415 250,00
Address
Damhaven 12
7100 Vejle

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Region
Danmark Syddanmark Sydjylland
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
FONDAZIONE POLIAMBULANZA
Italy
Net EU contribution
€ 340 575,00
Address
Via Bissolati 57
25124 Brescia

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Region
Nord-Ovest Lombardia Brescia
Activity type
Research Organisations
Non-EU contribution
€ 0,00
PLURISTEM LTD
Israel
Net EU contribution
€ 2 548 075,00
Address
Matam Industrial Park Bldg 20
31905 Haifa

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
BE THE PARTNER AG

Participation ended

Germany
Net EU contribution
€ 0,00
Address
Am Karlsbad 15
10785 Berlin

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Berlin Berlin Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
ICON CLINICAL RESEARCH LIMITED
Ireland
Net EU contribution
€ 356 250,00
Address
South County Business Park Leopardstown
18 Dublin

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Region
Ireland Eastern and Midland Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ICON CLINICAL RESEARCH (U.K.) LIMITED
United Kingdom
Net EU contribution
€ 75 000,00
Address
6 Stoneycroft Rise Chandlers Ford
SO533 LD Hampshire

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Region
South East (England) Hampshire and Isle of Wight South Hampshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ICON CLINICAL RESEARCH GMBH
Germany
Net EU contribution
€ 318 750,00
Address
Heinricht Hertz Strasse 26
63225 Langen

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Region
Darmstadt Offenbach, Landkreis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ICON CLINICAL RESEARCH SRO
Czechia
Net EU contribution
€ 131 250,00
Address
V Parku 2335/20
148 00 Prague Chodov

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Region
Severozápad Ústecký kraj
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ICON CLINICAL RESEARCH ISRAEL LTD
Israel
Net EU contribution
€ 262 500,00
Address
6 Ha'baal Shem Tov
7128906 Lod

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ICON ANKARA KLINIK ARASTIRMA DIS TICARET ANONIM SIRKETI
Turkey
Net EU contribution
€ 106 250,00
Address
Sogutozu Mahallesi Eskisehir Yolu Caddesi
Cankaya/ankara

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Region
Batı Anadolu Ankara Ankara
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
INTERNATIONAL OSTEOPOROSIS FOUNDATION
Switzerland
Net EU contribution
€ 100 025,00
Address
Rue Juste Olivier 9
1260 Nyon

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Region
Schweiz/Suisse/Svizzera Région lémanique Vaud
Activity type
Other
Non-EU contribution
€ 0,00
ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU

Participation ended

Italy
Net EU contribution
€ 190 000,00
Address
Via Fiorentina 151
53100 Siena

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Centro (IT) Toscana Siena
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST
United Kingdom
Net EU contribution
€ 74 812,50
Address
Headley Way The John Radcliffe Hospital
OX39DU Headington

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Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Research Organisations
Non-EU contribution
€ 0,00
BE THE PARTNER INC
United States
Net EU contribution
€ 440 275,00
Address
1506 Boston Providence Highway Suite 29a
02062 Norwood Ma

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
INNOVATION ACTA S.R.L.
Italy
Net EU contribution
€ 83 225,00
Address
Via D.a. Azuni, 9
00196 Roma

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Centro (IT) Lazio Roma
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00