Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, has expanded its five-year collaborative research agreement with the Berlin-Brandenburg Center for Regenerative Therapy at Charité - University Medicine Berlin.

The expanded agreement, which was executed on October 11 at the Berlin-Tel Aviv Business Forum in Tel Aviv, broadens the parties’ cooperation to include identification of orthopaedic indications that may be eligible for development under Europe’s Adaptive Pathways and conditional marketing approval in the European Union. Pluristem’s programme to develop PLX cells in critical limb ischemia is already under discussion with the EMA and other European stakeholders under the Adaptive Pathways.

Under the five-year collaborative research agreement, Pluristem and Charité have jointly completed a successful orthopaedic phase I/II study using PLacental eXpanded (PLX) cells in muscle injury. The parties have also collaborated on a variety of other indications, including kidney diseases such as acute kidney injury, cardiovascular indications such as inflammatory cardiomyopathy, and comprehensive immunological research for Pluristem’s peripheral artery disease clinical programmes.

Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charité, who served as senior scientist on the completed phase I/II orthopaedic study, commented, “In our studies PLX cells demonstrated the potential to improve overall muscle functionality, with an impressive magnitude of effect. An additional orthopaedic PLX indication has a promising potential.”

“Pluristem has enjoyed a very productive relationship with European regulators and our PLX cells have already been selected for the Adaptive Pathways in critical limb ischemia. Working with the prestigious Charité, we look forward to advancing an orthopaedic indication through Adaptive Pathways as well,” stated Pluristem chairman and CEO, Zami Aberman.

The Berlin-Brandenburg Center for Regenerative Therapies was founded as a cooperative research institution of the Charité University Hospital in Berlin and Germany's largest research association, the Helmholtz Association. The mission of the BCRT is to develop a translational platform for regenerative therapies from bench-to-bedside. The five clinical platforms–immune, musculoskeletal, hepatic, neuronal, and cardiovascular system–are cross-linked by technology platforms (basic science, bio-engineering, translational technologies).

The purpose of Europe’s Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programmes in early stages of development only. After a therapy is selected for the programme, the Adaptive Pathways Discussion Group provides detailed guidance to the applicant previous to the formal regulatory processes that precede a trial targeting early or conditional approval and further expansion of the indications.