A Randomized Controlled Trial on the Efficacy of Allogenic Ex-vivo Expanded Bone Marrow-Derived Mesenchymal Stem Cells in Treating Knee Osteoarthritis

The primary objective of this study is to evaluate the effect of **allogenic ex-vivo expanded bone marrow derived mesenchymal stem cells** on **knee osteoarthritis**. This investigation is clinically relevant as it aims to assess a potential therapeutic intervention for a condition that significantly impacts joint function and quality of life. The study seeks to determine whether this treatment can provide symptomatic relief or modify disease progression in patients with osteoarthritis in the knee joint.

The clinical trial focuses on individuals diagnosed with **osteoarthritis in the knee joint**. The study population includes both male and female participants, with an age range spanning from young adults to middle-aged individuals. 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 specific emphasis on lifestyle considerations such as diet, physical activity, or habits. The sponsor has not disclosed any key inclusion or exclusion criteria for this trial.

The clinical trial is designed to evaluate the effect of allogenic ex-vivo expanded bone marrow-derived mesenchymal stem cells on **osteoarthritis in the knee joint**. This study is structured as a randomized controlled trial, ensuring that participants are randomly assigned to either the treatment group or the control group, which enhances the reliability of the results by minimizing selection bias. The trial is expected to commence recruitment on January 5, 2026, and is projected to conclude by December 20, 2027, providing a comprehensive timeframe for data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed to ensure that only suitable candidates are enrolled. Following successful inclusion, participants will attend scheduled follow-up visits, which are critical for monitoring the treatment's effects and any potential adverse events. These visits will also facilitate the collection of data necessary for evaluating the primary and secondary endpoints of the study. The trial will culminate in an end-of-study visit, where final assessments are conducted, and participants' involvement in the study is concluded.

The expected duration of participant involvement will span the entire trial period, from the initial screening to the end-of-study visit. However, certain conditions may necessitate early termination from the study, such as the occurrence of significant adverse events, withdrawal of consent by the participant, or any other situation deemed necessary by the study investigators to ensure participant safety. The trial's design and procedures are meticulously crafted to uphold scientific rigor and participant safety throughout the study 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, it is not possible to provide further details about the **drug administration** or the **dosing schedules**. The trial documentation does not include any additional relevant information about the substances involved in the study. Consequently, the description remains limited to the general framework of the clinical trial without specific insights into the treatments used.

The clinical trial is scheduled to commence recruitment on January 5, 2026, with an estimated completion date of December 20, 2027. The trial is categorized under phase 10, indicating an advanced stage of clinical research. Efficacy assessments will be conducted to evaluate the therapeutic impact of the investigational product. 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.