Evaluation of Allogeneic Adipose-Derived Mesenchymal Stromal/Stem Cell Transplantation Tolerance in Patients with Critical Limb Ischemia

The primary objective of this study is to evaluate the **tolerance** of allogeneic adipose tissue-derived mesenchymal stromal/stem cells (AdMSC) transplantation in patients diagnosed with **critical limb ischemia**. This condition is a severe obstruction of the arteries which markedly reduces blood flow to the extremities and can lead to significant morbidity. Understanding the tolerance of AdMSC transplantation is clinically relevant as it may offer a novel therapeutic approach for patients with limited treatment options, potentially improving limb salvage rates and quality of life.

The clinical trial focuses on participants diagnosed with **critical limb ischemia**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. The trial does not specifically target a vulnerable population. However, the sponsor has not provided information regarding the total number of participants involved in the study. The selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the **tolerance** of allogeneic adipose tissue-derived mesenchymal stroma/stem cells (AdMSC) transplantation in patients diagnosed with **critical limb ischemia**. This study is structured as a Phase 1 trial, which typically focuses on assessing the safety and tolerability of a new treatment. The trial is expected to commence recruitment on October 1, 2024, and is projected to conclude by April 30, 2027. The trial will employ a randomized, double-blind, controlled design to ensure the reliability and validity of the results.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomly assigned to either the treatment group receiving AdMSC transplantation or a control group. Throughout the trial, participants will attend regular follow-up visits to monitor their health status, assess any adverse effects, and evaluate the efficacy of the treatment. These visits are crucial for collecting data on the primary and secondary endpoints of the study.

The end-of-study visit will mark the completion of the participant's involvement in the trial, where final assessments will be conducted to gather comprehensive data on the treatment's impact. The expected length 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 the occurrence of severe adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial's design and procedures are meticulously planned to ensure the safety of participants and the integrity of the data collected.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of this data limits the ability to describe the treatment protocols accurately.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, with an estimated recruitment start date of October 1, 2024, and an estimated end date of April 30, 2027. The efficacy assessment will be conducted using predefined parameters or endpoints, although specific details regarding these endpoints are not provided in the available data. The trial will follow a systematic approach to measure, collect, and analyze efficacy data, ensuring that the results are scientifically valid and reliable. The methods and schedule for these assessments, as well as any specific tools or instruments to be used, are not detailed in the provided information. The trial will adhere to rigorous standards typical of clinical research to evaluate the efficacy of the investigational product or intervention under study.