Intravascular Administration of Mesenchymal Stromal Cells from Wharton's Jelly for Systemic Immunomodulation in Severe Traumatic Brain Injury

The primary objective of the study is to evaluate the effects of intravascular administration of **mesenchymal stromal cells** derived from Wharton's Jelly of the umbilical cord on systemic immunomodulation and neuroinflammation in patients with severe traumatic brain injury (TBI). This is clinically relevant as it aims to explore a potential therapeutic approach to mitigate the inflammatory response and improve outcomes in severe TBI, a condition with significant morbidity and mortality. No secondary objectives are provided in the available data.

The clinical trial involves **adult patients** diagnosed with severe traumatic brain injury (TBI). The study population includes both male and female participants, with an age range classified under category code "3," which typically represents adults. The trial population is considered vulnerable, indicating that special considerations are in place to protect the participants' welfare. The sponsor has not provided information regarding the total number of participants. The selection process for the trial population, as well as any specific 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 effects of intravascular administration of **mesenchymal stromal cells** derived from Wharton's Jelly of the umbilical cord on systemic immunomodulation and neuroinflammation in patients with severe traumatic brain injury (TBI). The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thus minimizing bias. The estimated duration of the trial spans from October 2, 2023, to December 2, 2026, allowing for comprehensive data collection and analysis over a three-year period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough medical evaluation to confirm the diagnosis of severe TBI and ensure the absence of any exclusion criteria. Following successful screening, participants will be randomly assigned to either the treatment or control group. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' health status, assess the treatment's efficacy, and record any adverse events. These visits are crucial for collecting data on primary and secondary endpoints related to immunomodulation and neuroinflammation.

The end-of-study visit will mark the conclusion of the participant's involvement in the trial, during which final assessments will be conducted to evaluate the long-term effects of the treatment. The expected length of participant involvement is approximately three years, aligning with the overall trial duration. However, certain conditions may lead to early termination from the study, such as the occurrence of serious adverse events, withdrawal of consent, or non-compliance with study protocols. The trial's design and procedures are meticulously crafted to ensure the collection of robust and reliable data, contributing to the understanding of the therapeutic potential of mesenchymal stromal cells in severe TBI.

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 the administration of other medicinal products or their role in the trial.

Furthermore, the documentation lacks information on the **participant compliance monitoring** procedures, dosing schedules, and any additional relevant information about drug administration. The absence of these details limits the ability to provide a comprehensive description of the treatments involved in the clinical trial.

The clinical trial is scheduled to commence recruitment on October 2, 2023, with an estimated completion date of December 2, 2026. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Efficacy assessments will be conducted to evaluate the therapeutic impact of the investigational product. The specific parameters or endpoints for efficacy evaluation, as well as the methods and schedule for measuring, collecting, and analyzing these parameters, are not detailed in the provided data. The trial will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy outcomes.