Clinical evaluation of XSTEM, a novel stem cell therapy for treatment of difficult-to-heal venous leg ulcers

Purpose and goal:

Project aim: Evaluation of XSTEM® in a clinical study on patients with difficult-to-heal venous leg ulcers. XSTEM is a new stem cell product consisting of integrin alpha10beta1-selected and quality-assured mesenchymal stem cells (MSCs) derived from donated adipose tissue. The primary objective of the study is to evaluate the safety and tolerability of XSTEM after topical treatment of patients with difficult-to-heal venous leg ulcers.

A secondary objective is to evaluate preliminary effect up to 10 weeks after treatment in terms of wound healing rate and changes in perceived pain. Expected results and effects:

A batch of XSTEM has been manufactured in Xintela´s GMP-approved production facility for the clinical study. The batch was released with approved release assays according to schedule.

The clinical study is still ongoing. The study has taken longer than expected due to a difficult-to-recruit patient group. Patients with difficult-to-heal venous ulcers are often elderly with other diseases and complications, which makes participation challenging. Currently, three patients have completed the study. As the study has been extended, we do not yet have clinical study results to report.

Approach and implementation:

The clinical study has been planned and set up in collaboration with Folke Sjöberg and his team at Linköping University Hospital and a CRO was contracted to perform the study. Due to slow patient recruitment, three additional clinics in Sweden have been added and several protocol changes to facilitate recruitment have been made. In addition to advertising in the daily press and social media, a great deal of work has been done to actively seek potential patients through contact with for example primary care and home healthcare.