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Working Group 2: Technical

GMP conforming cell production, Standard Operation Procedures (SOPs) and Quality Management (QM)

WG Leader:      Prof. Jan E. Brinchmann, Norway
WG Co-Leader: Prof. Karl D. Sievert, Austria
WG Members:   Dr. Melanie Hart, Germany
                         Dr. Ander Izeta, Spain
                         Dr. Bernardo Herrera Imbroda, Spain
                         Dr. Daniel Eberli, Switzerland
                         Prof. Katia Monastyrskaja, Switzerland
                         Dr. Reinhold Zimmermann, Austria
                         Dr. Esra Foditsch, Austria
                         Prof. Nico Rijkhoff, Denmark
                         Prof. Pablo Pennisi, Denmark

During regular meetings WG2 will be responsible for determining the optimal cellular source for sphincter muscle regeneration.

This challenge is tackled by:

  • reviewing the state of the art in stem cell or progenitor cell-based muscle regeneration and repair
  • exploring possible sources of autologous progenitor or stem cells for sphincter therapy
  • developing SOPs for production of cells compliant with actual GMP regulations by the EMA  and valid EU and national laws
  • collaboration with experts from WG4 in advancing medical technology