The Danish Medicines Agency has approved a Phase I trial treating diabetic foot ulcer with allogeneic adipose tissue-derived mesenchymal stromal/stem cells (ASCs)

Cell2Cure will be investigating treatment of patients with diabetic foot ulcers with ASCs.

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.

The clinical trial will be carried out in collaboration with Professor Ole Lander Svendsen and his team at Bispebjerg University Hospital, Copenhagen, Denmark. The trial was approved by the Danish Medical Research Ethics Committees on May the 30th, 2022, and by the Danish Medicines Agency on June the 28th 2022. The clinical trial will investigate safety and efficacy of treatment with 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 to either ASC treatment or to a control group. The 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.

“We are really pleased with the approval from the Danish Medicines Agency so that we can follow the plan and start our clinical trial with treatment of patients with diabetic foot ulcers with our ASC product. The treatment concept has the potential to become a pioneering treatment for diabetic foot ulcers,”

says Professor Jens Kastrup, CEO and Clinical Director.