RecruitingPhase 1Phase 2NCT05549609

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

A Multi-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

Sponsor

Xintela AB

Enrollment

6 participants

Start Date

Oct 26, 2022

Study Type

INTERVENTIONAL

Conditions

Venous Leg Ulcer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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

Exclusion Criteria8

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

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Interventions

BIOLOGICALXSTEM-VLU

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.

OTHERVehicle

CryoStor CS10 cryomedium