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Objectives

Specific objectives of this Action are:

  • Establish an interdisciplinary network of experts focusing on cellular sphincter therapy. 
  • Integrate health authorities and patient advocacy groups at an early stage. 
  • Develop EMA conforming procedures for all steps required for sphincter therapy. 
  • Open a common platform with related medical technology companies to improve surgical and imaging tools for application of a cell based therapy. 
  • Define common needs and patient criteria for cell-based therapy. 
  • Harmonize surgical methodology and follow-up of cell based sphincter therapies. 
  • Generate knowledge on clinical outcomes and the best approach to sphincter therapy. 
  • Describe all requirements necessary for funding of a first phase I clinical study. 
  • Develop logistics for banking of cell and tissue samples for later studies.