Venous Leg Ulcer
Conditions
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.
Interventions
BIOLOGICALXSTEM-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.
OTHERVehicle
CryoStor CS10 cryomedium
Sponsors
Xintela AB
Vinnova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability: Adverse events (AEs) | From study start to 4 months after dosing | Frequency, seriousness and intensity of AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE) |
| Safety and tolerability: Local tolerability | 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) |
| Safety and tolerability: Number of participants with abnormal 12-lead electrocardiogram (ECG) | From study start to 4 months after dosing | Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs. |
| Safety and tolerability: Number of participants with abnormal vital signs | 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. |
| Safety and tolerability: Number of participants with abnormal laboratory test results | 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. |
| Safety and tolerability: Number of participants with abnormal physical examination findings | From study start to 4 months after dosing | Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The VAS consists of a 100 mm line from no pain (0 mm) to worst possible pain (100 mm). |
| Preliminary efficacy: Scar formation assessed by the Patient and Observer Scar Assessment Scale (POSAS) | 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. |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORFolke Sjöberg
Burn Centre, Linkoping University Hospital, Linkoping, Sweden
Outcome results
None listed