DEVELOPMENT SAFETY UPDATE REPORT MSC-EB 12.10.2022 – 11.10.2023

Warning

This publication doesn't include Faculty of Sports Studies. It includes Faculty of Medicine. Official publication website can be found on muni.cz.

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