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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

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

Ziel

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.
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Koordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Adresse

Chariteplatz 1
10117 Berlin

Deutschland

Aktivitätstyp

Higher or Secondary Education Establishments

EU-Beitrag

€ 1 715 512,50

Beteiligte (10)

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THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD

Vereinigtes Königreich

EU-Beitrag

€ 229 502,50

ODENSE UNIVERSITETSHOSPITAL

Dänemark

EU-Beitrag

€ 415 250

FONDAZIONE POLIAMBULANZA

Italien

EU-Beitrag

€ 340 575

PLURISTEM LTD

Israel

EU-Beitrag

€ 2 610 575

BE THE PARTNER AG

Deutschland

ICON CLINICAL RESEARCH LIMITED

Irland

EU-Beitrag

€ 1 250 000

INTERNATIONAL OSTEOPOROSIS FOUNDATION

Schweiz

EU-Beitrag

€ 100 025

ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU

Italien

EU-Beitrag

€ 260 600

OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST

Vereinigtes Königreich

EU-Beitrag

€ 74 812,50

BE THE PARTNER INC

Vereinigte Staaten

EU-Beitrag

€ 440 275

Projektinformationen

ID Finanzhilfevereinbarung: 779293

Status

Laufendes Projekt

  • Startdatum

    1 Januar 2018

  • Enddatum

    31 Dezember 2021

Finanziert unter:

H2020-EU.3.1.3.

  • Gesamtbudget:

    € 7 437 127,50

  • EU-Beitrag

    € 7 437 127,50

Koordiniert durch:

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Deutschland