CA23140 - Boost and secure ATMP for BURN patient (ESENBURN)

Accidental burns are among the main etiologies of trauma and death with 11 million consultations in hospitals and 300,000 deaths per year worldwide. The main aim and objective of ESENBURN COST action is to create, structure and support a network of biomanufacturers, burn centers, pre-clinical validation sites, regulatory bodies R&D departments to evaluate, boost and secure the clinical applications of advanced therapy medicinal product (ATMPs) for burn patients.

In particular it aims at: 

●       Harnessing all expertise within the network to share and agglomerate all fragmented knowledge and create an ad-hoc information platform compiling and implementing production sites with their regulatory authorizations (cell and/or gene therapy, tissue engineering), with the type of the ATMPs produced (type of cells or biological product, combined or not with a device, gene therapy …), with the clinical indications, facility and environment controls, national regulation application

●       Synergizing regulatory experts, selected Patients’ Associations, researchers, biomanufacturers and clinicians in order to guide the latter for the successful implementation of efficient and safe clinical applications, backed with a proper regulatory support to lift barriers

●       Disseminating knowledge for control, validation, production protocols but also in clinical practices to approach optimal consensus, to define guidelines, and to possibly set inputs for future standards

●       Training the medical teams Surgeon/anesthetist/nurses/ reeducation team for knowledge dissemination

●       Fostering networking between those who perform in vitro, ex vivo and animal clinical validation tests to propose guidelines combining ethics and regulatory request for efficacy and safety

●       Ensuring the longevity of such  a network, for patients, research and medical community worldwide.