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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - HIPGEN (Placenta-expanded adherent stromal cells (PLX-PAD) as an innovative therapy for improving recovery and survival following hip fracture arthroplasty â€“ HIPGEN, a multicenter phase III trial)

Teaser

Summary

The HIPGEN project aims at bringing the first regenerative therapy for improving recovery following a surgically treated injury to market approval. HIPGEN proposes a new innovative therapy, which is in advanced clinical development stage: allogeneic placental cell therapy with PLX-PAD cells for the enhanced recovery following hip fracture surgery. The focus of the HIPGEN trial are patients undergoing total or hemiarthoplasty after femoral neck fracture. These 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 due to the resulting immobility after fracture and surgery, and a mortality comparing to cancer with up to 30% during the first year. The elderly patients are massively challenged by the incidence of injury and the consequent surgery and exhibit a very low regenerative capacity. No therapy is currently available to address the problem of impaired regeneration and mobility and the risks, including the high mortality, after hip fracture surgery.

Work performed

Within the reporting period, we prepared and started a randomized, double-blind, multicentre, placebo-controlled phase III trial for restoring muscle function, mobilisation and reduction of post-operative stress-related immune disbalance in hip fracture patients treated with placenta-expanded adherent stromal cells (PLX-PAD cells) after arthroplasty. By these regenerative mechanisms, we also aim at improving the survival of these patients.
The initial phase of the project included preparation, submission and finalisation of all study documents. Clinical grade PLX-PAD batches were successful manufactured and used/stored for the patientsâ€™ treatment and sent for accompanying in-depth characterisation to the partners. As of June 2019 76 patients were found eligible for randomization into the trial. Currently 19 sites are active in Europe, Israel and in the US. The study patients will be investigated to identify surrogate biomarkers and to reveal paracrine as well as immune-mediated mechanisms of actions of PLX-PAD on muscle regeneration. The preparatory tasks for these analyses have also been finished and approvals have been received. These mechanistical side studies help to understand the mode-of-action of the applied therapy. To keep patients engaged during the trial, a HIPGEN-specific â€˜Be the Partnerâ€™ platform has been created and launched. In addition to the scientific progress, the overall awareness of Advanced Therapies in hip fracture patients and the HIPGEN project itself increased due to diverse dissemination activities by all partners, for example via social media, scientific and public presentations/posters as well as video interviews with the PI and project coordinator, the latter will be available soon on the HIPGEN and International Osteoporosis Foundation (IOF) website.

Final results

The HIPGEN-project generates comprehensive in depth understanding on the immunomodulatory and muscle trophic modes of action in a large and relevant patient cohort; thereby establishing a role model in the ground-breaking regenerative therapeutic field of Advanced Therapies by providing advanced business and reimbursement models.