CORDIS
EU research results

CORDIS

English EN
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

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.

Coordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Address

Chariteplatz 1
10117 Berlin

Germany

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 715 512,50

Participants (10)

Sort alphabetically

Sort by EU Contribution

Expand all

THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD

United Kingdom

EU Contribution

€ 229 502,50

ODENSE UNIVERSITETSHOSPITAL

Denmark

EU Contribution

€ 415 250

FONDAZIONE POLIAMBULANZA

Italy

EU Contribution

€ 340 575

PLURISTEM LTD

Israel

EU Contribution

€ 2 610 575

BE THE PARTNER AG

Germany

ICON CLINICAL RESEARCH LIMITED

Ireland

EU Contribution

€ 1 250 000

INTERNATIONAL OSTEOPOROSIS FOUNDATION

Switzerland

EU Contribution

€ 100 025

ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU

Italy

EU Contribution

€ 260 600

OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST

United Kingdom

EU Contribution

€ 74 812,50

BE THE PARTNER INC

United States

EU Contribution

€ 440 275

Project information

Grant agreement ID: 779293

Status

Ongoing project

  • Start date

    1 January 2018

  • End date

    31 December 2021

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 7 437 127,50

  • EU contribution

    € 7 437 127,50

Coordinated by:

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Germany