HIPGEN is a multicenter phase III trial which aims to bring the first regenerative therapy for improving recovery following a surgically treated injury to market approval. The new innovative therapy proposed (which is in advanced clinical development stage) is called allogenic placental cell therapy with PLX-PAD cells for the enhanced recovery following hip fracture surgery.

 

The HIPGEN project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 779293.

IOF is a member of the HIPGEN alliance, a network of 10 partners from eight countries, primarily with expertise in the fields of cell therapy development and clinical research in the field of orthopaedics. The International Osteoporosis Foundation’s role in the consortium is to fill the communication gap between science and patients. 

For complete information about the project visit the HipGen website the list of partners, visit the website.

View a report on the final meeting of September 12/13, 2022 in Brussels 

View the video of the Public Session on September 13, 2022

HIPGEN Objectives:
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 comparing to cancer with up to 30% during the first year. 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 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.