Evaluation of Safety, Tolerability, and Efficacy of XSTEM-VLU in Patients with Refractory Venous Leg Ulcers: A Phase I/IIa Randomized, Single-Blind Study

The primary objective of this study is 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**. This is clinically relevant as venous leg ulcers are a common and challenging condition to treat, often leading to prolonged patient discomfort and increased healthcare costs. The study aims to determine whether this novel treatment can improve healing outcomes and provide a new therapeutic option for patients with this condition.

The clinical trial involves participants with **difficult-to-heal venous leg ulcers**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. The trial does not focus on a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on specific criteria, although these criteria have not been disclosed. Lifestyle considerations such as diet, physical activity, or habits have not been specified. The trial aims to gather data from a diverse group of individuals to ensure comprehensive results.

The clinical trial is a multi-centre, **randomised**, single-blind Phase I/IIa study designed to evaluate the safety, tolerability, and efficacy of a single topical dose of allogeneic integrin α10β1-selected mesenchymal stem cells in patients with **difficult-to-heal venous leg ulcers**. The trial is expected to commence recruitment on October 26, 2022, and is estimated to conclude by June 30, 2025. The study involves a sequence of visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants who meet the inclusion criteria will be randomly assigned to receive either the investigational treatment or a control. The trial design ensures that neither the participants nor the investigators are aware of the treatment allocation, maintaining the integrity of the single-blind methodology.

Following the initial treatment administration, participants will attend scheduled follow-up visits to monitor safety and efficacy outcomes. These visits will include clinical assessments, laboratory tests, and documentation of any adverse events. The end-of-study visit will mark the completion of the participant's involvement, where final evaluations will be conducted to gather comprehensive data on the treatment's impact. The expected duration of participant involvement will vary depending on individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or non-compliance with study procedures. The trial's structured approach aims to generate robust data to inform future therapeutic strategies for managing difficult-to-heal venous leg ulcers.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is scheduled to conclude by June 30, 2025, with recruitment having commenced on October 26, 2022. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely employ standard methodologies for measuring and analyzing efficacy outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, assessed at predetermined timepoints throughout the trial duration. The absence of explicit endpoints suggests a focus on comprehensive data collection to evaluate the therapeutic impact of the intervention under investigation.