Treatment for hard-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
PHASE1; PHASE2 · Xintela AB · NCT05549609
This study tests a new cream called XSTEM-VLU to see if it helps people with hard-to-heal venous leg ulcers get better compared to a placebo.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xintela AB (industry) |
| Locations | 4 sites (Gothenburg and 3 other locations) |
| Trial ID | NCT05549609 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and preliminary efficacy of XSTEM-VLU, a topical treatment, for patients suffering from difficult-to-heal venous leg ulcers. Participants will be randomly assigned to receive either XSTEM-VLU or a placebo vehicle in addition to standard wound care. The treatment's effects will be monitored weekly for 10 weeks, with a follow-up visit at 4 months post-treatment to assess healing outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with venous leg ulcers that have not healed despite standard care for at least 6 weeks.
Not a fit: Patients with ongoing infections in the wound, autoimmune diseases, or other specified conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing rates for patients with chronic venous leg ulcers.
How similar studies have performed: While this approach is novel, similar studies targeting chronic wounds have shown promising results in improving healing outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gothenburg and 3 other locations
- Clinical Trial Center (CTC) — Gothenburg, Sweden (RECRUITING)
- Burn Centre, Linköping University Hospital — Linköping, Sweden (WITHDRAWN)
- Clinical Research Unit — Lund, Sweden (WITHDRAWN)
- Clinical Trial Consultants (CTC) Karolinska — Stockholm, Sweden (RECRUITING)
Study contacts
- Principal investigator: Folke Sjöberg — Burn Centre, Linkoping University Hospital, Linkoping, Sweden
- Study coordinator: Central contact
- Email: clinicaltrials@xintela.se
- Phone: +46 73 435 53 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Venous Leg Ulcer