Difficult-to-heal venous leg ulcers MedDRA version: 21.1 Level: LLT Classification code 10047260 Term: Venous ulceration System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: XSTEM-VLU
Pharmaceutical Form: Cutaneous suspension
INN or Proposed INN: Allogeneic integrin a10ß1-selected and expanded mesenchymal stem cells from human adipose tissue (XSTEM)
Other d
Sponsors
Xintela AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, patients must fulfil the following criteria: 1. Willing and able to give written informed consent for participation in the study. 2. Male or female patient aged =18 years at the time of the screening visit (Visit 1). 3. BMI =18.5 and =40.0 kg/m2. 4. Wound located on the lower part of the lower limb, with a predominant venous component. 5. Target wound has failed to heal despite standard wound care including compression therapy for a minimum of 6 weeks prior to the screening visit (Visit 1), as judged by the Investigator. 6. Patient who has been compliant to their prescribed compression therapy over the (at least) 6 weeks prior to the screening visit (Visit 1), as judged by the Investigator. 7. A surface area of the target wound of =2.00 and =40.00 cm2 measured using the SeeWound (or other wound planimetry measure) after standard wound care attention at the screening visit (Visit 1). 8. WOCBP must practice abstinence (only allowed when this is the preferred and usual lifestyle of the patient) or agree to use a highly effective method of contraception with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Patients must not enter the study if any of the following exclusion criteria are fulfilled: 1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient’s ability to participate in the study. 2. Any planned major surgery during the study. 3. Signs or symptoms of clinically significant ongoing infection (in the target wound) requiring anti-microbial treatment (including antibiotics) during the screening period (from Visit 1) until randomisation (Visit 5), as judged by the Investigator. Topical anti-microbial therapy being part of a patient’s standard wound care is allowed prior to Visit 5. 4. History of any autoimmune disease, such as but not limited to systemic lupus erythematosus, Addison’s disease, Crohn’s disease and type I diabetes mellitus. 5. B-HbA1C value =52 mmol/mol at the time of the screening visit (Visit 1). 6. Plaque psoriasis or any other skin disease that could interfere with the outcome of the study, as judged by the Investigator. 7. Ankle-brachial index 50.00 cm2 measured using SeeWound (or other planimetry measure).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterise the safety and tolerability of a single dose of XSTEM-VLU and vehicle as add on to standard wound care in patients with difficult-to-heal venous leg ulcers.;Secondary Objective: To assess preliminary efficacy of a single dose of XSTEM-VLU and vehicle as add on to standard wound care in patients with difficult-to-heal venous leg ulcers.;Primary end point(s): -Frequency, seriousness and intensity of adverse events (AEs) -Local tolerability, including need for debridement and clinical signs of wound infection -Clinically significant changes in vital signs, electrocardiogram (ECG), safety laboratory measurements (haematology, clinical chemistry, coagulation) and physical examination findings ;Timepoint(s) of evaluation of this end point: Regularly throughout the study, from dose until end of study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Wound area, measured weekly during 10 weeks post-administration and at 4 months, including (but not limited to): - Wound area reduction from baseline (absolute and percentage) - Proportion of patients with re-epithelialization of =95% and =50% of the wound area measured at baseline - Time to re-epithelialization of =95% and =50% of the wound area measured at baseline (The analysis of wound area may be further specified in the statistical analysis plan [SAP]) -Pain for the target wound and the affected leg, separately, assessed weekly during 10 weeks post-administration and at 4 months, using a Visual Analogue Scale (VAS) - Scar formation (Patient and Observer Scar Assessment Scale [POSAS] score) at week 10 and at 4 months;Timepoint(s) of evaluation of this end point: - Wound area, measured weekly during 10 weeks post-administration and at 4 months. - Pain for the target wound and the affected leg, separately, assessed weekly during 10 weeks post-administration, and at 4 months. - Scar formation at week 10 and at 4 months | — |
Countries
Sweden
Contacts
Public ContactClinical Research Manager
CTC Clinical Trial Consultants AB
Outcome results
None listed