The HIPGEN study includes a network of 10 partners from eight countries, as well as the International Osteoporosis Foundation (IOF) as a communications partner. It is a Phase III, multicenter, randomized, double-blind, placebo-controlled trial, designed to determine the efficacy, safety and tolerability of intramuscular injections of allogeneic placenta-expanded adherent stromal (PLX-PAD) cells for improved recovery following arthroplasty for hip fracture. 

The focus of the HIPGEN trial is on patients undergoing total or hemiarthroplasty after femoral neck fracture. Hip fractures are a major public health concern worldwide as they result in enormous direct and indirect costs and high mortality. According to the International Osteoporosis Foundation, of all osteoporosis-related fractures, hip fractures cause the most morbidity and mortality. Reported mortality rates are up to 20-24% in the first year after a hip fracture, and a greater risk of dying may persist for at least 5 years afterward. Loss of function and independence among survivors is profound, with 40% unable to walk independently, and 60% requiring assistance a year later. Because of these losses, 33% are totally dependent or in a nursing home in the year following a hip fracture.¹

There is currently no therapy available after hip fracture surgery to address the problem of impaired regeneration, reduced mobility and the associated risks, including the high mortality. By exploring the efficacy of allogeneic placental cell therapy with placenta-expanded adherent stromal (PLX-PAD) cells for enhanced recovery following hip fracture surgery, 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.

At the 4th annual meeting on March 1st, 2022, HIPGEN project partners - including Pluristem, leaders of the specific trial sites, and IOF as the HIPGEN Consortium communications partner - met to share an update of the clinical Phase III Study and to discuss ongoing progress, challenges, and next steps. An important milestone was reached when as of November 12, 2021 enrolment in the trial was completed, with 240 patients found eligible for randomization into the trial at 21 study sites in Europe, Israel, and in the USA. 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. 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.

HIPGEN project coordinator Professor Tobias Winkler, Charité Universitätsmedizin Berlin, stated:

“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 a significant impact on health services, future research projects in the field, and patient management.”

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The HIPGEN project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement n. 779293

Visit the HIPGEN website for further information.

1.    https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-os…