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Placenta-expanded adherent stromal cells (PLX-PAD) as an innovative therapy for improving recovery and survival following hip fracture arthroplasty – HIPGEN, a multicenter phase III trial

Periodic Reporting for period 3 - HIPGEN (Placenta-expanded adherent stromal cells (PLX-PAD) as an innovative therapy for improving recovery and survival following hip fracture arthroplasty – HIPGEN, a multicenter phase III trial)

Reporting period: 2021-01-01 to 2021-12-31

The HIPGEN project aims at bringing the first regenerative therapy for improving recovery following a surgically treated injury to market approval. The focus of the HIPGEN trial are patients undergoing total or hemiarthroplasty 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 of up to 30% during the first year. The injury itself as well as the consequent surgery presents a huge challenge for elderly patients whose regenerative capacity is low. There is currently no therapy available after hip fracture surgery to address the problem of impaired regeneration, reduced mobility and the risks, including the high mortality. HIPGEN proposes a new innovative therapy to address these issues, which is in an advanced clinical development stage: allogeneic placental cell therapy with placenta-expanded adherent stromal (PLX-PAD) cells for the enhanced recovery following hip fracture surgery.
The initial phase of the project included preparation, submission and finalisation of all study documents. Clinical grade PLX-PAD batches were successfully manufactured and stored/used for the patients’ treatment and sent for accompanying in-depth characterisation to the partners. Consequently, the 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 PLX-PAD cells after arthroplasty has been successfully completed. To meet the negative impact on enrollment and follow-up during the COVID-19 pandemic, home and phone visits were implemented in the study protocols.
As of December 31st 2021 enrollment was complete with 240 patients found eligible for randomization into the trial at 21 study sites in Europe, Israel and in the US. After the fulfilment of preparatory tasks analyzing the mechanism of action, samples from study patients are also studied in order to identify surrogate biomarkers for therapy response and to reveal paracrine as well as immune-mediated mechanisms of actions of PLX-PAD on muscle regeneration. 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 ‘Be the Partner’ 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 the HIPGEN website, social media, scientific and public presentations/posters at conferences and workshops as well as video interviews with the PI and project coordinator.
The HIPGEN project has the potential to advance the clinical application of an “off-the-shelf” cell product for the high, unmet medical need of recovery after hip fracture in elderly frail patients. It could lead to a transformation of the clinical management of hip fractures and in general to the establishment of future strategies for clinical development of Advanced Therapy Medicinal Products. The HIPGEN-project is contributing to a comprehensive in-depth understanding of the immunomodulatory and muscle trophic modes of action of PLX-PAD cells in a large and relevant patient cohort, thereby allowing translation into clinical applications. Consequently, HIPGEN will have significant impact on health services, future research projects in the field and patient management.
theraphy cell product
hip fracture
Flyer for German operators