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

NCT05549609 | Recruiting Phase 1

• 1 other identifier: XIN-XSTEM-201
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (6)

• Safety and tolerability: Adverse events (AEs)

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

  From study start to 4 months after dosing

• Safety and tolerability: Local tolerability

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

  From study start to 4 months after dosing

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

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

  From study start to 4 months after dosing

• Safety and tolerability: Number of participants with abnormal vital signs

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

  From study start to 4 months after dosing

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

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

  From study start to 4 months after dosing

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

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

  From study start to 4 months after dosing

Secondary Outcomes (5)

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

  From study start to 4 months after dosing

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

  From study start to 4 months after dosing

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

  From study start to 4 months after dosing

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

  From study start to 4 months after dosing

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

  At week 10 and at 4 months after dosing

Study Arms (2)

XSTEM-VLU

EXPERIMENTAL

Single topical dose of XSTEM-VLU

Biological: XSTEM-VLU

Vehicle

PLACEBO COMPARATOR

Single topical dose of CryoStor CS10

Other: Vehicle

Interventions

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.

XSTEM-VLU

Vehicle OTHER

CryoStor CS10 cryomedium

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xintela AB: lead
• Vinnova: collaborator

Study Sites (4)

Clinical Trial Center (CTC)

Gothenburg, SE-413 46, Sweden

RECRUITING

Burn Centre, Linköping University Hospital

Linköping, SE-581 85, Sweden

WITHDRAWN

Clinical Research Unit

Lund, SE-221 85, Sweden

WITHDRAWN

Clinical Trial Consultants (CTC) Karolinska

Stockholm, SE-171 64, Sweden

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

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

Study Officials

• Folke Sjöberg

  Burn Centre, Linkoping University Hospital, Linkoping, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Central contact

CONTACT

+46 73 435 53 42; clinicaltrials@xintela.se

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 22, 2022
• Study Start: October 26, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)