In the clinical study, which will be carried out in collaboration with Professor Folke Sjöberg and his team at the University Hospital in Linköping, 12 patients with difficult-to-heal venous leg ulcers will be treated with XSTEM or placebo. XSTEM/placebo will be applied onto the wounds and the patients will be followed for 10 weeks to evaluate safety and wound healing effect. The study will start after the summer and early results are expected by the end of 2022.
 
Difficult-to-heal venous leg ulcers, which affect about 4% of people over the age of 65, result in pain and reduced quality of life for patients as well as large costs for the healthcare system. There is currently no effective cure for this indication.
 
“We are really pleased with the approval from the Medical Products Agency so that we can start our clinical study in patients with difficult-to-heal venous leg ulcers according to plan. We now have the opportunity to generate clinical data with XSTEM within a short time and in a patient group where the medical need is huge. Our preclinical studies have shown that XSTEM has excellent wound healing capacity and has the potential to become a pioneering treatment for difficult-to-heal leg ulcers,” says Camilla Wennersten, Director Clinical Development.