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

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 Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Biological: XSTEM-VLU; Other: Vehicle

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Central contact; Phone Number: +46 73 435 53 42; Email: clinicaltrials@xintela.se

Study Locations

• Sweden
  • Gothenburg, Sweden, SE-413 46
    • Recruiting
    • Clinical Trial Center (CTC)
    • Contact: Phone Number: +46 31 343 99 19; Email: rekrytering.ctc.su@vgregion.se
    • Principal Investigator: Rahime Inci, MD
  • Linköping, Sweden, SE-581 85
    • Withdrawn
    • Burn Centre, Linköping University Hospital
  • Lund, Sweden, SE-221 85
    • Withdrawn
    • Clinical Research Unit
  • Stockholm, Sweden, SE-171 64
    • Recruiting
    • Clinical Trial Consultants (CTC) Karolinska
    • Contact: Phone Number: +46 18 30 33 99; Email: info@ctc-ab.se
    • Principal Investigator: Kaveh Azizi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XSTEM-VLU; Single topical dose of XSTEM-VLU	Biological: 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.
Placebo Comparator: Vehicle; Single topical dose of CryoStor CS10	Other: Vehicle; CryoStor CS10 cryomedium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The VAS consists of a 100 mm line from no pain (0 mm) to worst possible pain (100 mm).	From study start to 4 months after dosing
Preliminary efficacy: Scar formation assessed by the Patient and Observer Scar Assessment Scale (POSAS)	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.	At week 10 and at 4 months after dosing

Collaborators and Investigators

• Sponsor: Xintela AB
• Collaborators: Vinnova
• Investigators: Principal Investigator: Folke Sjöberg, Burn Centre, Linkoping University Hospital, Linkoping, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer; Leg Ulcer
• Other Study ID Numbers: XIN-XSTEM-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No