Project to support femoral neck fracture trial
Pluristem Therapeutics Inc. a developer of placenta-based cell therapy products, has announced that its Phase III study of PLX-PAD cells to support recovery following surgery for femoral neck fracture has been awarded an €7.4m.
This marks the second grant awarded to a Pluristem Phase III trial under the Horizon 2020 programme, following a €7.6m award for its ongoing Phase III study of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI), which was awarded in August 2016.
The Phase III trial of PLX-PAD cells in the treatment of femoral neck fracture will be a collaborative effort between Pluristem and an international consortium led by the Charité – Universitätsmedizin Berlin, under the leadership of Dr Tobias Winkler, Principal Investigator at the Berlin-Brandenburg Center for Regenerative Therapies, Julius Wolff Institute, Germany, and Center for Musculoskeletal Surgery, US.
The trial demonstrated that patients treated with Pluristem’s PLX-PAD cells during total hip arthroplasty experienced significant muscle regeneration compared to the control group with an improvement in muscle force and in muscle volume six months after surgery.
Winklers said: “Following the impressive results from the Phase I/II study of PLX-PAD cells in a similar orthopedic indication, we are excited to advance PLX-PAD cell therapy into a Phase III study to aid in muscle regeneration in patients recovering from femoral neck fracture. If similar results are achieved in this Phase III trial, it could show that PLX-PAD cells can improve outcomes in these procedures and change the way recovery is managed worldwide.”
Pluristem plans to enrol patients at clinical sites throughout Europe and the US. The study is expected to serve as a pivotal trial for regulatory approval in both regions.
