DEVELOPMENT SAFETY UPDATE REPORT MSC-EB 12.10.2022 – 11.10.2023

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Authors	DEMLOVÁ Regina KUBÁTOVÁ Jana
Year of publication	2023
MU Faculty or unit	Faculty of Medicine
Web	MSC-EB
Description	The first periodic report for the MSC-EB study evaluates the safety data received by the sponsor of the study during the period 12/10/2022 to 11/10/2023. The clinical evaluation took place in 1 center in the Czech Republic. This study aims to evaluate a new therapeutic approach to promote wound healing in patients with EB who are i.d. application of mesenchymal stromal cells (MSC) derived from adipose tissue of allogeneic donors. This single-arm, non-randomized, unblinded phase I/II clinical trial. It took place in 1 center in the Czech Republic. The total duration of the patient's participation in KH is 365 days. The study will take place in two consecutive cohorts. A total of 15 patients will participate in the study.
Related projects:	CZECRIN - Czech National Node to the European Clinical Research Infrastructure Network