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IRCT20221130056672N4 IRCT 2024-01-21 Tehran University of Medical Sciences Safety and efficacy of injection of Umbilical Cord Blood Serum derived exosomes for skin lesions in patients with chronic psoriasis Safety and efficacy of injection of Umbilical Cord Blood Serum derived exosomes for skin lesions in patients with chronic psoriasis(Phase ۱ of clinical trial) 2024-01-20 anticipated 30 Complete https://irct.ir/trial/74914 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: After the injection, the patients are followed up for 3 months to measure the efficacy and safety. Injection is done in 3 different doses to identify the optimal dose for the treatment of patients, also another lesion in the same patient is treated with corticosteroid ointment as a positive control. If it is successful, it means that with no side effects such as redness, itching, peeling from the lesion site, so that if no adverse event occurs, we will start the intervention with the next dose, each of the selected doses in three times with an interval. It will be injected for a month, and in the meantime, we will follow up the patients by being in contact with the patients and receiving pictures of the lesion site. Each of the doses (50, 100, and 200 micrograms per square centimeter in one milliliter), the injection will be done once every month for 3 months, then at the end of the fourth month, the injection site will be sampled in order to check the healing improvement. The lesion and the reduction of the level of inflammatory factors will be done at the molecular level, Randomization description: Using the simple randomization method, the patients who visit the Dr. Nilfroshzadeh's skin clinic are placed in 3 groups, so that one envelope is randomly selected for each patient from the number of 30 sealed envelopes. Inside each envelope is the letter A, B or C. Patients of groups A, B, and C are injected with concentrations of 50, 100, and 200 microgram per milliliter per square centimeter of the skin lesion, respectively, Blinding description: The injection and use of the ointment is performed in two different lesions in the same patient, the patients are not told which is the main treatment. The clinical care provider is unaware of the dose (50/100/200 µg/ml) used and the doctor evaluating the outcome is aware that It is unclear which lesion was treated with injection and which was treated with ointment. 1 Psoriasis. Intervention 1: The first intervention group: under treatment with local injection of exosome (derived from cord blood serum purchased from Apsa company) with a concentration of 50 micrograms per milliliter: exosomes derived from human cord serum per square centimeter of the skin lesion injected for 3 It will be done once a month. Intervention 2: Control group: topical use of fluocinolone corticosteroid ointment from Tehran tehranchemie factory every morning and night. Intervention 3: The second intervention group: under treatment with local injection of exosome (derived from cord blood serum purchased from Apsa company) 100 micrograms per milliliter of exosomes derived from human cord serum per square centimeter of the skin lesion injected once every month for 3 months will be done regularly. Intervention 4: The third intervention group: under treatment with local injection of exosome (derived from cord blood serum purchased from Apsa company) 200 micrograms per milliliter of exosomes derived from human cord serum per square centimeter of the skin lesion injected once every month for 3 months will be done regularly. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals. When: Six months after the publication and printing of the article To whom: Academic researchers and experts Conditions: In order to analyze the results of the study outcomes Where to obtain: etaghiabadi@sina.tums.ac.ir How to obtain: It can be submitted after review by the Research Council of the Skin and Stem Cell Research Center of Tehran University of Medical Sciences, which usually takes 2 to 3 months. Comments:
public Ehsan Taghiabadi
No.4, 4th floor, Maryam dead end. South Kamraniyeh
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 etaghiabadi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Ehsan Taghiabadi
No. 4 , 4th floor, Maryam dead end, South Kamraniyeh
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 etaghiabadi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age older than 18 years Patients with chronic plaque psoriasis for at least 6 months PASI index 3 to 12 Lesion intensity 1 to 3 (rating 0 to 5) Lack of proper response to standard treatments including local treatments, light therapy and systemic treatments Not creating new lesions or increasing the size of previous lesions in the last 3 months Skin lesion with BSA higher than 10% 18 years 65 years Both Use of systemic immunosuppressive drugs in the last 4 weeks and topical drugs except emollients in the last 2 weeks Severe underlying disease (liver-kidney and heart failure) Increase of liver enzymes > 3 times normal and creatinine > 2 Patients with diabetes mellitus, patients with a history of hepatitis B, C or HIV Pregnant and nursing mothers Patients with immunodeficiency, patients with malignancy, presence of debilitating disease, presence of active infection L40 Psoriasis Treatment - Other Treatment - Drugs Treatment - Other Treatment - Other The first intervention group: under treatment with local injection of exosome (derived from cord blood serum purchased from Apsa company) with a concentration of 50 micrograms per milliliter: exosomes derived from human cord serum per square centimeter of the skin lesion injected for 3 It will be done once a month. Control group: topical use of fluocinolone corticosteroid ointment from Tehran tehranchemie factory every morning and night. The second intervention group: under treatment with local injection of exosome (derived from cord blood serum purchased from Apsa company) 100 micrograms per milliliter of exosomes derived from human cord serum per square centimeter of the skin lesion injected once every month for 3 months will be done regularly. The third intervention group: under treatment with local injection of exosome (derived from cord blood serum purchased from Apsa company) 200 micrograms per milliliter of exosomes derived from human cord serum per square centimeter of the skin lesion injected once every month for 3 months will be done regularly. PASI index:Psoriasis Area Severity Index (PASI). Timepoint: The measurement will be at the beginning of the study (before the start of the intervention) and 7, 14, 21, 30 and 60 days after the first injection. Method of measurement: analysis and impact of data using biometric like High-Frequency Sonography. Safety. Timepoint: At the beginning of the intervention, in each re-visit session and one month after the end of the treatment period (four months after the start of the treatment). Method of measurement: Patient history. Tehran University of Medical Sciences Approved 2024-01-07 Research Ethics Committees of Research Institute for Oncology, Hematology and Cell Therapy - Tehran No.4, 4th floor, Maryam dead end. South Kamraniyeh Tehran Tehran Iran (Islamic Republic of)