A team of researchers from the Medical University of Warsaw will conduct a clinical trial to check the safety and efficacy of a medicinal product, in which the active substance is allogeneic mesenchymal cells obtained from adipose tissue, in the treatment of diabetic foot syndrome. The study received over 9 million PLN funding from the Medical Research Agency in a competition concerning development of the new diagnostic and therapeutic procedures in the area of civilization diseases.
In the project entitled "Evaluation of safety and efficacy of an advanced therapy medicinal product containing live ASCs in the treatment of diabetic foot syndrome - a double-blind randomized study (Acronym: FootCell)", an advanced therapy medicinal product designed, developed and manufactured in the Laboratory for Cell Research and Application (LBBK) of the Medical University of Warsaw will be tested.
The clinical trial will be conducted in two research centers - the main researcher is Beata Mrozikiewicz-Rakowska MD, PhD, from the Department of Diabetology and Internal Diseases, UCC Medical University of Warsaw, headed by prof. Leszek Czupryniak. The study is based on preliminary encouraging results obtained by the LBBK and the Department team in a pilot treatment experiment, in which preparation of this type was administered in an open, i.e. unblinded, observation without randomization.
The project includes the search for the mechanisms of action of applied cells with the use of multiomic methods. It will be implemented in consortium with the University of Łódź.