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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-26

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Venous Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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XSTEM-VLU

Single topical dose of XSTEM-VLU

Group Type EXPERIMENTAL

XSTEM-VLU

Intervention Type BIOLOGICAL

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.

Vehicle

Single topical dose of CryoStor CS10

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type OTHER

CryoStor CS10 cryomedium

Interventions

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XSTEM-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.

Intervention Type BIOLOGICAL

Vehicle

CryoStor CS10 cryomedium

Intervention Type OTHER

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No