Projects

W REALIZACJI

Evaluation of the safety and effectiveness of an advanced therapy medicinal product containing live ASC cells in the treatment of diabetic foot syndrome - a double-blind, randomized study (Acronym: FootCell)"

The project was funded by the Medical Research Agency under the competition for non-commercial clinical trials in the area of civilization diseases ABM/2021/3.

The goal of the project

The aim of the project is to evaluate safety and efficacy of an advanced therapy medicinal product, containing allogeneic mesenchymal cells derived from adipose tissue as the active substance (ATMP-ASC) - for the treatment of Diabetic Foot Syndrome.

The way of implementation

The study is based on the preliminary results obtained by the Laboratory for Cell Research and Apllication of the Medical University of Warsaw and the Department of Diabetology and Internal Diseases of the UCK 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. No drug-related side effects were observed, and at the same time, a statistically significant improvement in wound healing in DFU patients was obtained after administration of the cell-containing formulation, compared to the analogous treatment without cells. Both effects require confirmation in a randomized, double-blind clinical trial, which is the subject of this study. To strengthen the reliability of the results, adaptive randomization was planned based on selected clinical features and important factors related to the course of diabetes.

The study participants will be assigned to 3 groups: control or 1 of 2 study groups (A and B), which differ in terms of the ASC administration algorithm. In the arm A, patients will receive 2 doses of ASC with an interval of 2 weeks, in the arm B, patients will receive 1 dose of ASC and 1 dose of placebo with an interval of 2 weeks. In the control group, placebo will be administered twice with an interval of 2 weeks.

In addition to evaluation the safety and effectiveness of the therapy, a multi-omics, i.e. transcriptomic, proteomic and methylomic analysis of tissue and wound exudate harvested at various time points of the clinical observations, will be one of the most important part of the study. It increases the likelihood of detecting the molecular processes associated with the mechanisms of action of ASC. Such data, coming from a clinical trial, are unique and will be a desirable contribution to the state of the art in the field of cell-based therapies.