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IRCT20240706062337N1 IRCT 2024-10-10 Vice Chancellor for Research, Shiraz University of Medical Sciences Investigating the safety and efficacy of Wharton's jelly mesenchymal stem cell exosomes on corneal epithelium defects Investigating the effect of exosomes with regenerative and anti-inflammatory potential derived from Wharton jelly mesenchymal stem cells on the treatment of corneal epithelial defects 2024-12-17 anticipated 20 Complete https://irct.ir/trial/77822 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To create a random sequence, we use numbers to assign to participants using random functions in different software such as R or Python. We use the clinical characteristics of the patients to limit, and the division into groups is done based on the initial clinical condition of the person, Blinding description: In the present study, double blinding was used to reduce the errors and conscious or unconscious effects of the researchers in measuring the outcomes. In this way, both patients and all researchers related to patients are unaware of the treatment received by the patient. Considering that this is a single-center study, by using a code, the patient is identified whether he received the active drug or placebo. 2 Corneal epithelium defects. Intervention group : Description: Patients will receive exosomes derived from Wharton jelly mesenchymal stem cells (WJ-MSCs) with regenerative and anti-inflammatory potential. Exosomes are prepared in the cleanroom of the University of Medical Sciences. Dosage and administration: Exosomes are prepared as 10% dilution with tearlose and packaged in eye drops. The drops are prescribed topically on the affected eye(s) once a day for 4 weeks. Objective: To evaluate the efficiency of exosomes derived from WJ-MSC in improving corneal epithelial healing and reducing inflammation. Intervention group 2: Description: Patients will receive a standard treatment for corneal epithelial defects, such as tearlose artificial tears or conventional anti-inflammatory eye drops. Dosage and Administration: Standard treatment is performed according to usual clinical guidelines. Objective: To compare the effectiveness of standard treatment with exosome treatment.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the fact that I have not yet consulted with the colleagues participating in the project, therefore I have not specified the relevant program
public Mahmoud Nejabat
Zand Blvd., in front of the Faculty of Medicine, at the beginning of Asadabadi St
Shiraz Iran (Islamic Republic of) 7134997446 +98 71 3233 0073 psorc@yahoo.com Shiraz University of Medical Sciences scientific Fatima Sani Jahromi
Zand Blvd., in front of the Faculty of Medicine, at the beginning of Asadabadi St
Shiraz Iran (Islamic Republic of) 7134997446 +98 71 3233 0073 fsanie@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Participants aged 18-65 years. Individuals diagnosed with corneal epithelial defects, confirmed by clinical examination and imaging techniques. Patients with moderate to severe corneal epithelial defects that have not responded to conventional treatments. Participants should be generally healthy, without systemic diseases that could affect the study outcomes. Written informed consent obtained from all participants. Patients who have not received any other experimental treatments for corneal epithelial defects in the past 6 months. No active ocular infections or other significant ocular diseases (e.g., glaucoma, uveitis) that could interfere with the study. Willingness and ability to comply with study procedures and follow-up visits. 18 years 65 years Both Patients with uncontrolled systemic diseases such as diabetes, autoimmune disorders, or severe cardiovascular conditions. Presence of other significant ocular diseases (e.g., glaucoma, uveitis) or active ocular infections that could interfere with the study outcomes. Patients who have received other experimental treatments for corneal epithelial defects within the past 6 months. Known allergies to any components of the exosome preparation or related substances. Pregnant or breastfeeding women. Patients currently undergoing immunosuppressive therapy or with a history of organ transplantation. Inability or unwillingness to comply with study procedures and follow-up visits. Any other medical condition that, in the opinion of the investigator, could compromise the safety of the patient or the integrity of the study data. H18.9 Disorder of cornea, unspecified Treatment - Drugs Intervention group : Description: Patients will receive exosomes derived from Wharton jelly mesenchymal stem cells (WJ-MSCs) with regenerative and anti-inflammatory potential. Exosomes are prepared in the cleanroom of the University of Medical Sciences. Dosage and administration: Exosomes are prepared as 10% dilution with tearlose and packaged in eye drops. The drops are prescribed topically on the affected eye(s) once a day for 4 weeks. Objective: To evaluate the efficiency of exosomes derived from WJ-MSC in improving corneal epithelial healing and reducing inflammation. Intervention group 2: Description: Patients will receive a standard treatment for corneal epithelial defects, such as tearlose artificial tears or conventional anti-inflammatory eye drops. Dosage and Administration: Standard treatment is performed according to usual clinical guidelines. Objective: To compare the effectiveness of standard treatment with exosome treatment. Improvement of epithelial defects. Timepoint: It is measured in weeks 1, 2 and 4. Method of measurement: Clinical examinations. Vice Chancellor for Research, Shiraz University of Medical Sciences Approved 2024-07-08 Shiraz University of Medical Sciences Zand St., in front of Palestine St. Shiraz Fars Iran (Islamic Republic of)