The Meeting, organized by the HIPGEN project’s coordinator Dr Tobias Winkler (Charité - Universitätsmedizin Berlin) in collaboration with host organization ALTA, brought together more than 30 participants representing a network of ten organizations located in eight countries. It was an important opportunity for all the key stakeholders to update each other on progress and discuss current challenges.
The HIPGEN project is currently in the phase III clinical trial stage, and many clinical sites across Europe have begun recruiting patients to start the trials. As well, trials will be run in the US and Israel. This phase will be key to the success of the project, assessing the efficacy, safety and tolerability of PLX-PAD intra-muscular injections for improved recovery following arthroplasty for hip fractures.
The HIPGEN network primarily represents expertise in the fields of cell therapy development and clinical research in the field of orthopaedics. In contrast, the International Osteoporosis Foundation’s (IOF) role is to help bridge the communication gap between science and patients through outreach to the IOF global community of osteoporosis-related stakeholders and patients.
At this First Annual Meeting the Project Coordinator gave an overview of the status of the entire project and, together with Charitè team, Pluristem Therapeutics as sponsor of the clinical study, and ICON (CRO) he gave insights on all aspects related to the clinical trial. All the other partners (University of Oxford, Oxford University Hospital NHS Trust, Odense University Hospital, CREM, Be The Partner Inc, ALTA and IOF) had the opportunity to present the work done during the first year of the project.
IOF Science Project Coordinator Masaki Fujita presented on several key IOF operations in science, communications and advocacy. He described how IOF will contribute to the HIPGEN project by focusing on the communication and dissemination of the project’s key achievements, and by raising awareness of this new innovative therapy among global experts, researchers, policy makers and patients.
Hip fractures are a major public health concern, with high direct and indirect costs due to the resulting immobility after fracture and surgery, and a mortality of up to 30% during the first year (comparable to cancer). At present, there is no therapy available to address the problem of impaired regeneration and mobility and the consequences, including high mortality, after hip fracture surgery.
HIPGEN is a multicenter phase III trial which aims to address the problem of impaired regeneration and mobility after hip fracture surgery. The trial seeks to bring to market approval the first regenerative therapy (called allogenic placental cell therapy with PLX-PAD cells for the enhanced recovery following hip fracture surgery).
HIPGEN will work to:
- Confirm safety and efficacy of PLX-PAD cell therapy in patients undergoing arthroplasty for hip fracture by means of a randomized, double-blind, multicentre, placebo-controlled, phase III study
- Challenge and widen the immunomodulatory mode of action (MoA), seen in a recent phase I/IIa trial, in a larger group of patients with diverse background in adaptive immunity (“immune aging”) and correlate the efficacy of the treatment to patients´ immune experience using a well standardised immune monitoring approach
- Evaluate the degree of immune-mediated mechanisms exerted by the standardized PLX-PAD product in muscle regeneration
- Define by in vitro and ex vivo MoA studies the PLX-PAD immune-mediated consequences on muscle tissue structure and function through a reshaped pro-regenerative environment
- Create a strategic engagement of the patients and family as early adopters to the cell product and foster patient and family centered care
- Achieve a role model for combating major trauma/surgery-related challenged immune balance in elderly patients with poor clinical outcome, like after any major surgery in elderly patients
The successful completion of the phase III study would enable market entry in the hip fracture indication.
For complete information about HIPGEN, and the list of partners, click here.
The HIPGEN project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 779293.