Xintela announces that the XSTEM® treatment in the clinical Phase I/IIa study on patients with difficult-to-heal venous leg ulcers was considered safe and well tolerated and thus achieved the primary objective of the study. XSTEM, which consists of allogeneic (donated) integrin α10β1-selected mesenchymal stem cells, is developed and manufactured by Xintela.
Xintela’s completed Phase I/IIa clinical study in patients with difficult-to-heal venous leg ulcers is a placebo-controlled, randomized study. The patients in the study have received one dose of XSTEM (100,000 cells/cm2, 4 patients) or placebo (2 patients) applied to the wound and then followed weekly for 10 weeks and after 4 months. Xintela has previously communicated that the number of patients enrolled was reduced from 12 to 6 due to slow recruitment and that the final results will focus on safety and tolerability which is the primary objective of the study.
The study has now been analysed and the results showed that XSTEM administered as a single dose was safe and well tolerated and thus achieved the primary objective of the study. The majority of the adverse events reported in the study were assessed as mild and unlikely to be related to the study treatment or study procedure. No serious adverse events were reported.
“This is an important clinical milestone for Xintela. Based on these positive safety results from the difficult-to-heal venous leg ulcer study, the effect of XSTEM can be evaluated on other wound indications going forward”, says Evy Lundgren-Åkerlund, Xintela’s CEO.