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

Launched by XINTELA AB · Sep 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called XSTEM-VLU for patients with difficult-to-heal venous leg ulcers, which are open sores on the leg caused by poor blood flow. The goal is to see if this treatment is safe, tolerated well by patients, and effective in helping these wounds heal. Participants in the study will receive either XSTEM-VLU or a placebo (a treatment that looks like the real one but has no active ingredients) in addition to their regular wound care. The study will follow patients weekly for 10 weeks after treatment, and then they will return to the clinic 4 months later for a final check-up.

To be eligible for this study, participants must be at least 18 years old and have a specific type of leg wound that hasn't healed despite receiving standard care for at least 6 weeks. They should also have been following their prescribed compression therapy, which is a common treatment for this condition. However, people with certain health issues, like infections in the wound or specific autoimmune diseases, cannot participate. This trial is currently looking for volunteers, and it offers a potential new option for those struggling with stubborn leg ulcers.

Gender

ALL

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