Ethics and regulation
In 2011, as soon as the announcement of CRYOSTEM’s selection for the ANR’s “Cohorts” call for projects, the collective took steps to meet the ethical and regulatory requirements that conditioned the start of the sampling collection activity within its network.
The documents intended for patients (consents, information notes and additional information) were drafted in collaboration with several patient associations. At the same time, the Steering Committee has defined a set of harmonized procedures and protocols required for the proper functioning of the network. In the fall of 2011, all ethical and regulatory files were submitted to the various official bodies (governmental, ethical, legal). Less than one year later, all the authorizations (ministerial, CPP, CCTIRS and CNIL) were obtained, which allowed CRYOSTEM to include a first patient in the cohort as early as July 2012.
Since 2012, these authorizations have been updated on a regular basis, as the network and the project grew, in keeping with the legislation in force.
The initial objective of the constitution of the collection was to conduct research in the field of GvHD, being the major complication of HSCT. This research topic was broadened to all the complications of HSCT, after validation in March 2016 by the Committee of the Protection of Persons – CPP – South Mediterranean I. The entire collection and cryopreserved samples are now available for research into the extend field of HSCT complications.