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

Venous Leg Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05549609
• Other study ID #: XIN-XSTEM-201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 26, 2022
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Xintela AB
• Contact: Central contact
• Phone: +46 73 435 53 42
• Email: clinicaltrials[@]xintela.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 including compression therapy for a minimum of 6 weeks
• Patient who has been compliant to their prescribed compression therapy over the (at least) 6 weeks prior to screening
• 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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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.

Other:
• Vehicle
CryoStor CS10 cryomedium

Locations

Country	Name	City	State
Sweden	Clinical Trial Center (CTC)	Gothenburg
Sweden	Burn Centre, Linköping University Hospital	Linköping
Sweden	Clinical Research Unit	Lund
Sweden	Clinical Trial Consultants (CTC) Karolinska	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Xintela AB	Vinnova

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Preliminary efficacy: Wound area reduction (absolute and percentage) compared to baseline		From study start to 4 months after dosing
Secondary	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
Secondary	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
Secondary	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
Secondary	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