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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-SC1-2017-Single-Stage-RTD
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Coordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Address
Chariteplatz 1
10117 Berlin
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 750 387,50

Participants (11)

THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 244 502,50
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
REGION SYDDANMARK
Denmark
EU contribution
€ 415 250
Address
Damhaven 12
7100 Vejle
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
FONDAZIONE POLIAMBULANZA
Italy
EU contribution
€ 340 575
Address
Via Bissolati 57
25124 Brescia
Activity type
Research Organisations
PLURISTEM LTD
Israel
EU contribution
€ 2 548 075
Address
Matam Industrial Park Bldg 20
31905 Haifa
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BE THE PARTNER AG

Participation ended

Germany
EU contribution
€ 0
Address
Am Karlsbad 15
10785 Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ICON CLINICAL RESEARCH LIMITED
Ireland
EU contribution
€ 1 250 000
Address
South County Business Park Leopardstown
18 Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INTERNATIONAL OSTEOPOROSIS FOUNDATION
Switzerland
EU contribution
€ 100 025
Address
Rue Juste Olivier 9
1260 Nyon
Activity type
Other
ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU

Participation ended

Italy
EU contribution
€ 190 000
Address
Via Fiorentina 151
53100 Siena
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 74 812,50
Address
Headley Way The John Radcliffe Hospital
OX39DU Headington
Activity type
Research Organisations
BE THE PARTNER INC
United States
EU contribution
€ 440 275
Address
1506 Boston Providence Highway Suite 29A
02062 Norwood Ma
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INNOVATION ACTA S.R.L.
Italy
EU contribution
€ 83 225
Address
Via D.a. Azuni, 9
00196 Roma
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)