Hip fractures are a major public health concern in the European Union, with an increasing incidence of 1 million patients per year, high direct and indirect costs due to the resulting immobility after fracture and surgery, and with a high one-year mortality rate of 25%-30%.
Currently, no single therapy is available to address the common problem of impaired regeneration and mobility and the high mortality seen after hip fracture surgery. There is consequently a great need for the development of a new therapeutic option which will: improve regenerative capacities, and thereby; improve mobility and prevent immobility; prevent immobility associated diseases; reduce trauma/major surgery related stress reaction.
HIPGEN, a multi-center phase III clinical study under Horizon 2020 funding, will carry out a Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, designed to determine the efficacy, safety and tolerability of intramuscular injections of Allogeneic PLX-PAD Cells, for improved recovery following arthroplasty for hip fracture. The project, coordinated by the Charité Universitätsmedizin Berlin, involves a total of 9 partners from 8 countries. Partners include internationally renowned European orthopaedic and trauma centres (University of Oxford, Odense University Hospital) among other clinics and research institutes.
The involvement of patients and the consideration of their views and needs is a very important part of the HIPGEN project. As a catalyst for improved patient engagement, an innovative patient platform implemented by 'Be the Partner' will be used for the first time in a trial of an advanced therapy medicinal product. As well, the International Osteoporosis Foundation (IOF) will play a role in raising awareness about the project and the need for improved care following hip fractures by disseminating information through its large European and international membership, including patient societies, and among the broader community of healthcare professionals and health authorities.
To find out more about HIPGEN and to keep abreast of project news, visit the new website.