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)" will test an advanced therapy medicinal product designed, developed and manufactured in the Laboratory for Cell Research and Application of the Medical University of Warsaw, under the direction of Professor Małgorzata Lewandowska-Szumieł.
The clinical trial will be conducted in two centers - the principal investigator is Beata Mrozikiewicz-Rakowska, MD, PhD, from the Department of Diabetology and Internal Medicine, UCC MUW, headed by Prof. Leszek Czupryniak. The study is based on preliminary encouraging results obtained by the LBBK Laboratory and the Department team in a pilot treatment experiment, where a formulation of this type was administered in an open, i.e., unblinded observation without randomization.
The project includes the search for mechanisms of action of applied cells with the use of multiomic methods. It will be implemented in consortium with the University of Łódź.
Diabetic foot syndrome (DFS) is the result of long-term diabetes. It occurs in all types of the disease. The research shows that among people with type 2 diabetes, ulceration will occur in 25 percent of people during their lifetime. Up to 50 percent of elderly patients have more than one factor that increases the risk of foot ulceration, i.e.: neuropathy, hypertension, or elevated body mass index.
The care of a patient with DFS requires an efficient multidisciplinary team of experienced diabetologists, surgeons, orthopedists, interventional radiologists, nurses and physiotherapists. Despite efforts, treatment fails repeatedly, requiring amputation of the limb. It is estimated that in developed countries DFS takes the first place among the causes of non-traumatic lower limb amputations. Compared to 31 European countries, Poland is on the 10th place.
In 2015 in Poland, there were 1,795 amputations resulting from diabetes. Many of these could be prevented by intensifying treatment early in the development of DFS. Therefore, the search for an effective treatment for patients with this condition that will allow faster healing and reduce infectious complications as well as reduce the risk of failures requiring limb amputation is important.