A Single-centre, Randomised, Single-blind Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of a Single Topical Dose of Allogeneic Integrin α10β1-selected Mesenchymal Stem Cells (XSTEM-VLU) in Patients With Difficult-to-heal Venous Leg Ulcers

  • participants needed
  • sponsor
    Xintela AB
Updated on 21 September 2023


The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers. The study is randomised and the patients will receive either XSTEM-VLU or vehicle as add on to standard wound care.

The patients will be followed weekly for 10 weeks after treatment. At 6 months after treatment, the patients will return to the clinic for an end-of-study visit.

Condition Venous Leg Ulcer
Treatment Vehicle, XSTEM-VLU
Clinical Study IdentifierNCT05549609
SponsorXintela AB
Last Modified on21 September 2023

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