Evaluation of Allogenic Adipose Tissue-Derived Mesenchymal Stromal Cells in Primary Progressive Multiple Sclerosis: An Open-Label Phase I Trial

The primary objective of the study titled "MAESTRO-4MS: Allogenic Adipose tissue-derived Mesenchymal Stromal Cells for the treatment of **Primary Progressive Multiple Sclerosis**: an open-label phase I clinical trial" is to evaluate the safety and potential therapeutic effects of allogenic adipose tissue-derived mesenchymal stromal cells in patients with Primary Progressive Multiple Sclerosis. This objective is clinically relevant as it aims to explore a novel treatment approach for a condition characterized by a steady progression of neurological disability, for which there are currently limited therapeutic options.

The clinical trial involves participants diagnosed with **Primary Progressive Multiple Sclerosis**. The study population includes both male and female subjects, with an age range category code of 3, which typically corresponds to adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The selection criteria for the trial population have not been disclosed, and no principal inclusion criteria have been specified. The general health status of the participants is not detailed in the available data.

The clinical trial is designed to evaluate the safety and efficacy of **allogenic adipose tissue-derived mesenchymal stromal cells** for the treatment of **Primary Progressive Multiple Sclerosis**. This is an open-label, phase I trial, with an estimated recruitment start date of April 1, 2024, and an anticipated end date of January 1, 2029. The trial will involve a series of structured visits, beginning with an inclusion visit where participants will undergo screening to determine eligibility based on predefined criteria. Following successful inclusion, participants will be enrolled in the study and will attend scheduled follow-up visits to monitor their response to the treatment and assess any adverse effects. The trial will conclude with an end-of-study visit, where final assessments will be conducted to evaluate the overall outcomes of the intervention.

Participants are expected to be involved in the study for the duration of the trial, which may extend up to several years, depending on individual response and the progression of the disease. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent, or any other medical or ethical reasons deemed necessary by the investigators. The trial's methodology is structured to ensure rigorous data collection and analysis, with a focus on maintaining the integrity and reliability of the results. The study's design and procedures adhere to ethical guidelines and regulatory requirements, ensuring the safety and well-being of all participants throughout the trial duration.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information in the source data, further details about the **experimental medication** and any **non-experimental treatments** cannot be provided. The trial documentation should be consulted for comprehensive information regarding the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is April 1, 2024, with an anticipated end date of January 1, 2029. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. These assessments may include the use of validated scales, laboratory tests, or patient-reported outcomes to measure potential therapeutic effects. The trial will adhere to a predefined schedule for measuring and collecting data, ensuring systematic analysis of the efficacy parameters throughout the study duration. The results will contribute to understanding the investigational product's potential benefits and inform subsequent phases of clinical development.