A Single-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

  • STATUS
    Recruiting
  • days left to enroll
    16
  • participants needed
    12
  • sponsor
    Xintela AB
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Updated on 17 October 2022
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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 6 months after treatment, the patients will return to the clinic for an end-of-study visit.

Details
Condition Venous Leg Ulcer
Treatment Vehicle, XSTEM-VLU
Clinical Study IdentifierNCT05549609
SponsorXintela AB
Last Modified on17 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Written informed consent for participation in the study
Male or female patient aged ≥18 years
BMI ≥18.5 and ≥35.0 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 ≥7 and ≤15 cm2

Exclusion Criteria

Signs or symptoms of clinically significant ongoing infection requiring intravenous or oral systemic 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
Concomitant treatment that may interfere with the stem cell treatment
Patients who are immunocompromised due to disease or for other reasons such as the use of systemic immunosuppressants
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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