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Study aim
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Investigation of the safety and effectiveness of exosome derived from human umbilical cord jelly Wharton mesenchymal stem cells injection compared to intralesional triamcinolone injection in the treatment of alopecia areata: a randomized, blinded clinical trial
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Design
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This study is conducted as a phase 1 study on 20 patients with alopecia areata. In the intervention group, each patient will receive 3 sessions at 4-week intervals, with exosome injections in each session, and in the control group, each patient will receive triamcinolone injections in 3 sessions at 1-month intervals.
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Settings and conduct
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This project is being carried out at the Skin and Stem Cell Research Center of Tehran University of Medical Sciences. The intervention group will receive exosome injections, while the control group will receive triamcinolone injections.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: men and women with alopecia areata, age 18 years and older and less than 50 years, complete patient consent to participate in the project. Exclusion criteria: platelet disorders, thrombocytopenia, patients receiving anticoagulants, patients with malignancy, receiving chemotherapy in the last 5 years, patients with sepsis, smoking, pregnancy, ulcers or active infections at the treatment site.
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Intervention groups
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In the intervention group, patients receive three sessions, one month apart, of intradermal injection of one cc of exosomes at a concentration of 50 micrograms per milliliter in the area with hair loss, and in the control group, patients receive three sessions, one month apart, of intradermal injection of one cc of triamcinolone at a concentration of 2.5-5 mg per milliliter in the area with hair loss.
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Main outcome variables
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The amount of hair loss; side effects; patient's satisfaction; tolerability