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.
Field of science
- /medical and health sciences/health sciences/public and environmental health
- /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug
- /medical and health sciences/basic medicine/immunology
- /medical and health sciences/medical biotechnology/cells technologies
Programme(s)
Call for proposal
H2020-SC1-2017-Single-Stage-RTD
See other projects for this call
Funding Scheme
RIA - Research and Innovation action
Coordinator
10117 Berlin
Germany
Participants (11)
OX1 2JD Oxford
7100 Vejle
25124 Brescia
31905 Haifa
Participation ended
10785 Berlin
18 Dublin
1260 Nyon
Participation ended
53100 Siena
OX39DU Headington
02062 Norwood Ma
00196 Roma
