Dose Escalation Study of Allogeneic Adipose-Derived Stromal/Stem Cells in Patients with Crohn’s Fistula

The primary objective of this study is to evaluate the **dose escalation** of allogeneic adipose-derived stroma/stem cells for the treatment of **Crohn’s fistula**. This is clinically relevant as Crohn’s fistula represents a challenging complication of Crohn's disease, often requiring innovative therapeutic approaches to improve patient outcomes. The study aims to determine the optimal dosing strategy to enhance the therapeutic efficacy and safety profile of the stem cell treatment in managing this condition.

The clinical trial focuses on participants diagnosed with **Crohn's fistula**. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants involved in the study. Participants were selected without any explicit mention of lifestyle considerations such as diet, physical activity, or habits. The sponsor has not disclosed detailed inclusion or exclusion criteria for this trial.

The clinical trial is designed to evaluate the **dose escalation** of allogeneic adipose-derived stroma/stem cells for the treatment of **Crohn’s fistula**. This study is structured as a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thereby minimizing bias. The trial is set to commence on October 1, 2024, with an estimated completion date of April 1, 2027, indicating a total duration of approximately two and a half years.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This visit is crucial for determining participant suitability based on predefined inclusion and exclusion criteria. Following successful screening, participants will be enrolled in the trial and randomly assigned to either the treatment or control group. Throughout the study, participants will attend regular follow-up visits, which are essential for monitoring the safety and efficacy of the treatment, as well as for collecting data on primary and secondary endpoints. The trial will conclude with an end-of-study visit, where final assessments are conducted, and participants are debriefed on the study outcomes.

The expected length of participant involvement in the trial is contingent upon the study's timeline, with individual participation lasting until the end-of-study visit unless early termination is warranted. Conditions that may lead to early withdrawal from the study include adverse events, non-compliance with study protocols, or withdrawal of consent by the participant. The trial is conducted in accordance with ethical guidelines and regulatory requirements, ensuring the safety and well-being of all participants throughout the study duration.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is scheduled to commence recruitment on October 1, 2024, with an estimated completion date of April 1, 2027. The trial is categorized under phase 7, indicating a specific stage in the clinical research process. Efficacy assessments will be conducted throughout the trial to evaluate the therapeutic impact of the intervention. However, specific parameters or endpoints for efficacy evaluation, such as symptom improvement scores, biomarker levels, or disease remission rates, are not detailed in the available data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters, including any tools or instruments involved, are also not specified. The trial's design and execution will adhere to standard clinical trial protocols to ensure the reliability and validity of the efficacy assessments.