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.
Fields of science
- medical and health scienceshealth sciencespublic health
- medical and health sciencesclinical medicinesurgery
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- medical and health sciencesbasic medicineimmunology
- medical and health sciencesmedical biotechnologycells technologies
Programme(s)
Funding Scheme
RIA - Research and Innovation action
Coordinator
10117 Berlin
Germany
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Participants (16)
OX1 2JD Oxford
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7100 Vejle
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25124 Brescia
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31905 Haifa
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Participation ended
10785 Berlin
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
18 Dublin
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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.
SO533 LD Hampshire
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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.
63225 Langen
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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.
148 00 Prague Chodov
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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.
7128906 Lod
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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.
Cankaya/ankara
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1260 Nyon
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53100 Siena
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
OX39DU Headington
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02062 Norwood Ma
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
53100 Siena
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.