The first patient with diabetic foot ulcer was treated with Cell2Cure’s allogeneic adipose tissue-derived mesenchymal stromal cell product (C2C_ASCs) January 24, 2023 at Bispebjerg University Hospital, Copenhagen, Denmark. The STEMFOOT study is carried out in collaboration with Professor Ole Lander Svendsen and Wound Healing Center, Bispebjerg University Hospital.
The study team was very encouraged by the demonstrated very easy and smooth preparation of the C2C_ASC cell product, which without any problems was delivered in 5 subcutaneous injections in healthy tissue around the ulcer. The outcome of the treatment will be evaluated in the following 12 weeks period.
Diabetic foot ulcers is a very huge problem for the patients and the health care system. One of the most severe complications to diabetes is foot ulcers, which affects up to 26 million annually. A feared diabetic ulcer complication is the need for lower limb amputation and globally a diabetic person is amputated every 30 sec. There is currently no effective cure for this indication.
This phase I clinical study STEMFOOT will investigate the safety and efficacy of treatment with C2C_ASCs in addition to conventional treatments for healing and complications of foot ulcers in diabetes patients. A total of 30 patients will be randomized 1:1 either to C2C_ASC treatment or to a control group.
This treatment concept has the potential to become a pioneering treatment for diabetic foot ulcers.