Cell2Cure will be investigating treatment of patients with diabetic foot ulcus with C2C_ASC.
The clinical study will be carried out in collaboration with Professor Ole Lander Svendsen and his team at Bispebjerg University Hospital, Copenhagen, Denmark. The study was approved by the Danish Ethical Medical Committees of Science May 30, 2022, and by the Danish Medical Agency on 28. of June 2022. The clinical study will investigate safety and efficacy of treatment with allogeneic adipose tissue-derived mesenchymal stromal cells (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. The C2C_ASC group will be treated with subcutaneous injections of the cell product around the ulcus and patients will be followed for 12 weeks. The first patient is expected to be treated in the autumn of 2022 and results are expected by the end of 2023.
One of the most severe complications to diabetes is foot ulcers, which affects up to 26 million annually. Lower limb amputation is a feared complication associated with foot ulcers, and globally a person is amputated every 30 sec due to diabetes. There is currently no effective cure for this indication.
“We are really pleased with the approval from the Danish Medicines Agency so that we can follow the plan and start our clinical study with treatment of patients with diabetic foot ulcers with our cell product C2C_ASC. The treatment concept has the potential to become a pioneering treatment for diabetic foot ulcers,” says Professor Jens Kastrup, CEO and Clinical Director.