Xintela starts its second clinical study (Phase I/IIa) with XSTEM® for the treatment of difficult-to-heal venous leg ulcers. XSTEM, which consists of allogeneic (donated) integrin α10β1-selected mesenchymal stem cells, is developed and manufactured by Xintela.
The recruitment of patients for the Phase I/IIa study for the treatment of difficult-to-heal venous leg ulcers, which is carried out at Linköping University Hospital, has now begun. Twelve patients with difficult-to-heal venous leg ulcers will receive a treatment of XSTEM or placebo applied to the wound and will then be followed up weekly for 10 weeks and after 6 months. The primary goal of the study is to show that the treatment is safe but also that XSTEM has a positive effect on wound healing. Early safety and efficacy data are expected before the end of 2022.
“We are very excited to start the second clinical study with our stem cell product XSTEM. Our previous preclinical studies have shown that XSTEM has an excellent wound healing effect in a preclinical model and has the potential to become a pioneering treatment for difficult-to-heal leg ulcers and other skin defects,” says Xintela’s CEO Evy Lundgren-Åkerlund.
