Assessment of the safety and efficacy of an advanced therapy medicinal product containing living ASCs in the treatment of diabetic foot syndrome - a randomized, double-blind study (FootCell)

The aim of the project is to conduct a non-commercial clinical study of the safety and efficacy of an advanced therapy medicinal product, in which the active substance is allogeneic mesenchymal cells obtained from adipose tissue (ATMP-ASC) in the treatment of DFU. The study is based on the preliminary results obtained by the Research Laboratory Team - Cell Bank of the Medical University of Warsaw and the Department of Diabetology and Internal Medicine of the Medical University of Warsaw, as part of a pilot treatment experiment, where a preparation of this type was administered in an open, i.e. unblinded, observation without randomization. One hundred and five patients aged> 18 years who have been diagnosed with uninfected neuropathic diabetic foot syndrome will be enrolled in the study.