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Completed

NCT Number: NCT05549609

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

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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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Trial Center (CTC), Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XSTEM-VLU

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

Other

CryoStor CS10 cryomedium

Primary outcomes

  1. Safety and tolerability: Adverse events (AEs)

    Time frame: From study start to 4 months after dosing

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

  2. Safety and tolerability: Local tolerability

    Time frame: From study start to 4 months after dosing

    Local tolerability evaluated by direct inspection by need for debridement (Yes/No) and clinical signs of wound infection (Yes/No)

  3. Safety and tolerability: Number of participants with abnormal 12-lead electrocardiogram (ECG)

    Time frame: From study start to 4 months after dosing

    Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.

  4. Safety and tolerability: Number of participants with abnormal vital signs

    Time frame: From study start to 4 months after dosing

    Vital signs include blood pressure, pulse and body temperature. Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.

  5. Safety and tolerability: Number of participants with abnormal laboratory test results

    Time frame: From study start to 4 months after dosing

    Laboratory tests include clinical chemistry, haematology and coagulation parameters. Abnormal values assessed by the Investigator as clinically significant will be reported as AEs.

  6. Safety and tolerability: Number of participants with abnormal physical examination findings

    Time frame: From study start to 4 months after dosing

    Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.

Secondary outcomes

  1. Preliminary efficacy: Wound area reduction (absolute and percentage) compared to baseline

    Time frame: From study start to 4 months after dosing

  2. Preliminary efficacy: Proportion of patients with re-epithelialization of >=95% and >=50% of the wound area measured at baseline

    Time frame: From study start to 4 months after dosing

  3. Preliminary efficacy: Time to re-epithelialization of >=95% and >=50% of the wound area measured at baseline

    Time frame: From study start to 4 months after dosing

  4. Preliminary efficacy: Pain for target wound and the affected leg using Visual Analogue Scale (VAS)

    Time frame: From study start to 4 months after dosing

    The VAS consists of a 100 mm line from no pain (0 mm) to worst possible pain (100 mm).

  5. Preliminary efficacy: Scar formation assessed by the Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: At week 10 and at 4 months after dosing

    The POSAS is divided into two scales (for patient and for observer), each with six items scored numerically (1 -10). The lowest score "1" corresponds to normal skin.

Sponsors and collaborators

Lead sponsor

Xintela AB

Industry

Collaborators

  • Vinnova

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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