Regenerative cell therapy after hip fracture
20 December 2017. The HIPGEN project at the Berlin-Brandenburg Center for Regenerative Therapies (BCRT) of the Charité – Universitätsmedizin Berlin is committed to improving the mobilization of patients after a hip prosthesis implantation after femoral neck fracture. The focus is on a Phase III clinical trial investigating the effects of a foreign cell therapy on post-operative muscle healing. The international multicenter study is made possible by research funding from the EU’s Horizon 2020 program amounting to 7.4 million euros.
With about one million cases a year in the EU, hip fractures pose major challenges to health care systems. As the number of older people, who are mostly affected, grows, the need for better care continues to rise. Due to degenerative aging processes, muscle wasting and age-related changes in the immune system, elderly patients have a limited regeneration capacity. HIPGEN's novel approach, in the context of the implantation of a hip prosthesis, aims to improve the recovery of muscle function through a regenerative cell therapy. "During the operation, so-called PLX cells are injected into the injured muscle tissue. These mesenchymal cells are obtained from the placenta and have particular regenerative and immunomodulatory capabilities,” explains the project’s coordinator Dr. Tobias Winkler, Head of the Research Group Advanced Therapy in Compromised Patients in the Clinical Research Field Musculoskeletal System at BCRT, and orthopedist and surgeon at the Center for Musculoskeletal Surgery (CMSC) and researcher at the Julius Wolff Institute (JWI) of the Charité.
In addition to the stimulus for regeneration, postoperative stress-related immune imbalances should also be reduced. The goal of the international team of physicians and researchers is to mobilize patients earlier and easier after surgery and thus lower the mortality rate. So far, there is no therapy worldwide addressing these issues. "In the now planned Phase III study, we will investigate for the first time the effects of an allogeneic, i.e. donor-derived, cell therapy on postoperative muscle healing and the associated improvement in mobility after hip replacement," says Dr. Winkler. "Conventional therapies usually focus on the primary treatment of the fracture. The negative consequences of impaired movement function and of stress are usually disregarded," says the scientist.
HIPGEN is an international collaborative project involving a large number of clinical and academic institutions, industry partners and a patient organization. It is based on extensive previous preclinical studies and a Phase I/II clinical trial, also performed at the BCRT, demonstrating that the intramuscular injection of placental cells increases the contractile force and the volume of healing hip muscles.
Cooperation partners of the HIPGEN project are: Charité – Universitätsmedizin Berlin (Germany), University of Oxford NDORMS (UK), Department of Orthopedic Surgery and Traumatology, Odense University Hospital (Denmark), Centro di Ricerca E. Menni, Fondazione Poliambulanza-Istituto Ospedaliero ( Italy), Pluristem Therapeutics Inc. (Israel), Be the Partner AG (Germany), ICON Clinical Research (Ireland), International Osteoporosis Foundation (Switzerland), ALTA Ricerca e Sviluppo in Biotechnology Srlu (Italy). The European funding program Horizon 2020 supports the development of science, innovation, a competitive economy and sustainable development – taking breakthroughs from the lab to the market.