A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers

Xintela AB6 enrolled

Overview

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 4 months after treatment, the patients will return to the clinic for an end-of-study visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Venous Leg Ulcer

Interventions

XSTEM-VLUBIOLOGICAL

XSTEM-VLU is an allogeneic, adipose tissue-derived, integrin alpha10beta1-selected and expanded mesenchymal stem cell (MSC) product for the treatment of venous leg ulcers.

VehicleOTHER

CryoStor CS10 cryomedium

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Major Inclusion Criteria: * Written informed consent for participation in the study * Male or female patient aged ≥18 years * BMI ≥18.5 and ≥40.0 kg/m2 * Lower leg wound due to venous insufficiency * Target wound has failed to heal despite standard wound care for a minimum of 6 weeks * A surface area of the target wound of ≥2 and ≤40 cm2 Major Exclusion Criteria: * Signs or symptoms of clinically significant ongoing infection i the target wound requiring anti-microbial treatment * History of autoimmune disease, such as but not limited to systemic lupus erythematosus, Addison's disease, Crohn's disease and type I diabetes mellitus * B-HbA1C value ≥52 mmol/mol * Plaque psoriasis or any other skin disease that could interfere with the outcome of the study * Arterial insufficiency * History of any malignancy within the past 5 years * Target wound diagnosed as a malignant wound, neuropathic wound, pressure wound or osteomyelitis * Patients who are immunocompromised due to disease or for other reasons such as the use of systemic immunosuppressants

Locations (2)

Clinical Trial Center (CTC)

Gothenburg, Sweden

Clinical Trial Consultants (CTC) Karolinska

Stockholm, Sweden

Outcomes

Primary Outcomes

Safety and tolerability: Adverse events (AEs)

Frequency, seriousness and intensity of AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)