Clinical trial NCT05549609: A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Venous Leg Ulcer
Lead sponsor: Xintela AB
Sponsor class: INDUSTRY
Collaborators: name: Vinnova
First posted: 2022-09-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability: Adverse events (AEs)
timeFrame: From study start to 4 months after dosing
measure: Safety and tolerability: Local tolerability
timeFrame: From study start to 4 months after dosing
measure: Safety and tolerability: Number of participants with abnormal 12-lead electrocardiogram (ECG)
timeFrame: From study start to 4 months after dosing
measure: Safety and tolerability: Number of participants with abnormal vital signs
timeFrame: From study start to 4 months after dosing
measure: Safety and tolerability: Number of participants with abnormal laboratory test results
timeFrame: From study start to 4 months after dosing
measure: Safety and tolerability: Number of participants with abnormal physical examination findings
timeFrame: From study start to 4 months after dosing
Secondary outcomes:
measure: Preliminary efficacy: Wound area reduction (absolute and percentage) compared to baseline
timeFrame: From study start to 4 months after dosing
measure: Preliminary efficacy: Proportion of patients with re-epithelialization of >=95% and >=50% of the wound area measured at baseline
timeFrame: From study start to 4 months after dosing
measure: Preliminary efficacy: Time to re-epithelialization of >=95% and >=50% of the wound area measured at baseline
timeFrame: From study start to 4 months after dosing
measure: Preliminary efficacy: Pain for target wound and the affected leg using Visual Analogue Scale (VAS)
timeFrame: From study start to 4 months after dosing
measure: Preliminary efficacy: Scar formation assessed by the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: At week 10 and at 4 months after dosing
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Clinical Trial Center (CTC)
city: Linköping
country: Sweden
facility: Burn Centre, Linköping University Hospital
city: Lund
country: Sweden
facility: Clinical Research Unit
city: Stockholm
country: Sweden
facility: Clinical Trial Consultants (CTC) Karolinska
Study officials:
affiliation: Burn Centre, Linkoping University Hospital, Linkoping, Sweden
name: Folke Sjöberg
role: PRINCIPAL_INVESTIGATOR
References: