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IRCT20240508061704N3 IRCT 2025-05-10 Shiraz University of Medical Sciences The effect of stem cell secretions isolated from the newborn's umbilical cord in the treatment of dry eye manifestations and tear secretion in patients with transplant versus host disease Effect of human umbilical cord Whartons jelly-derived Mesenchymal stem cells exosomes in treatment of Dry Eye Related to Graft-Versus-Host Disease 2024-12-05 anticipated 10 Complete https://irct.ir/trial/78708 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 1 Dry eye in GVHD disease. Intervention 1: Intervention group: First, exosomes isolated from umbilical cord Wharton's jelly mesenchymal stem cells are isolated and stored in phosphate buffered saline (PBS) in a freezer. After admission, the patient's right eye will be treated with exosome as the intervention group. First, artificial tears will be injected into the right eye for 2 weeks until the baseline level is normalized, and then the intervention will be performed in the form of 10 micrograms of exosomes per drop, twice a day for 14 days in one eye of the patient. Intervention 2: Control group: After taking the patient, the patient's left eye will be considered as a control. PBS buffer alone will be used for the control eye. Yes - There is a plan to make this available What will be shared: Demographic characteristics from the results of a project to investigate effect of human umbilical cord Whartons jelly-derived Mesenchymal stem cells exosomes in treatment of Dry Eye Related to Graft-Versus-Host Disease When: Immediately after the publication of the article To whom: Researchers Conditions: Send researchers' requests via email and make a commitment to applicants to protect the data Where to obtain: Sending researchers' requests via e-mail to the e-mail address of the executor and in charge of the project, Dr. Negar Azarpira- negarazarpira@gmail.com How to obtain: The applicant researcher has sent his request to the email address of the executive and project manager, Dr.Negar Azarpira, to the email address of negarazarpira@gmail.com. After reviewing it within a week, after receiving a commitment, the data will be sent to the applicant via email. Comments:
public Negar Azarpira
Mulla Sadra St., Khalili St., Mohammad Rasoolullah Research Tower
Shiraz Iran (Islamic Republic of) ۷۱۹۳۶۳۵۸۹۹ +98 71 3628 1407 negarazarpira@gmail.com Shiraz University of Medical Sciences scientific Negar Azarpira
Mulla Sadra St., Khalili St., Mohammad Rasoolullah Research Tower
Shiraz Iran (Islamic Republic of) ۷۱۹۳۶۳۵۸۹۹ +98 71 3628 1407 negarazarpira@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients between 30-60 years old who have dry eyes and have been clinically and serologically diagnosed with GVHD by an ophthalmologist and hematologist Patients in whom the previous use of artificial tears could not relieve the symptoms of dry eyes Patients who have symptoms of eye redness, dryness, burning sensation, foreign body sensation, eye surface discomfort or visual fatigue in at least one eye Patients whose tear secretion test in both eyes is ≤ 10 mm / 5 minutes and tear break time is less than 10 seconds and the degree of corneal fluorescein staining is more than 4. 30 years 60 years Both People who are allergic to any medicine Pregnant or lactating women Patients with active fungal, bacterial or viral keratitis or conjunctivitis People who have serious heart, lung, liver or kidney or systemic diseases Patients who have incurable eye diseases before the study; Such as glaucoma, uveitis People who use contact lenses and do not want to remove them in the study People who have had eye surgery (including cataract surgery) in the last three months People who have simultaneously enrolled in other interventional clinical studies People who have used eye drops that may affect the clinical study in the last 24 hours. T86.0 Complications of bone marrow transplant Treatment - Other Treatment - Other Intervention group: First, exosomes isolated from umbilical cord Wharton's jelly mesenchymal stem cells are isolated and stored in phosphate buffered saline (PBS) in a freezer. After admission, the patient's right eye will be treated with exosome as the intervention group. First, artificial tears will be injected into the right eye for 2 weeks until the baseline level is normalized, and then the intervention will be performed in the form of 10 micrograms of exosomes per drop, twice a day for 14 days in one eye of the patient. Control group: After taking the patient, the patient's left eye will be considered as a control. PBS buffer alone will be used for the control eye. Tear secretion is measured using the Schirmer test, which measures the amount of wetting of filter paper. Timepoint: Measurements are taken before the start of treatment and after 12 weeks. Method of measurement: Filter paper is placed next to the eye and the amount of wetting by tears is reported in millimeters. The amount of change in the height of the tear meniscus is measured. Timepoint: Measurements are taken before the start of treatment and after 12 weeks. Method of measurement: Imaging is performed with a slit lamp device. The detection of foreign bodies in the eye is measured using fluorescein orange and blue light. Timepoint: Measurements are taken before the start of treatment and after 12 weeks. Method of measurement: Number. Shiraz University of Medical Sciences Approved 2024-02-17 Ethics committee of Shiraz University of Medical Sciences Shiraz - Zand Street - Shiraz University of Medical Sciences central building Shiraz Fars Iran (Islamic Republic of)