First patient dosed in Xintela's clinical study on difficult-to-heal leg ulcers
Xintela announces that the first patient has been dosed in the company's clinical Phase I/IIa study with XSTEM® in patients with difficult-to-heal venous leg ulcers. XSTEM, which consists of allogeneic (donated) integrin α10β1-selected mesenchymal stem cells, is developed and manufactured by Xintela.
Xintela’s ongoing Phase I/IIa clinical study in patients with difficult-to-heal venous leg ulcers is a placebo-controlled, randomized study. Twelve patients with difficult-to-heal venous leg ulcers will receive one dose of XSTEM or placebo applied to the wound and will then be followed weekly for ten weeks. 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.
"It is gratifying that the first patient in the study has now been dosed. This is a patient group that is difficult to recruit and we are very pleased that our investments in additional clinics and amendments in the study protocol are showing results. We are now hoping for a successful recruitment of the remaining patients”, says Camilla Wennersten, Xintela's Director Clinical Development.