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IRCT20221105056398N1 IRCT 2022-12-05 Pars igene Ltd. Co. personalized therapy based on mesenchymal stem cell extract in alopecia. clinical study of a personalized therapy based on mesenchymal stem cell extract in hair regeneration in patients with alopecia. 2023-01-10 anticipated 60 Complete https://irct.ir/trial/66650 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: block randomization method using randomized numbers, Blinding description: Using a placebo for the control group. individuals in both placebo and non-personalized stem cell extract groups are blinded and go through the same process and receive a product with the same design, packaging and appearance. The physician who is responsible for the evaluation of intervention is blinded. the personalized study arm is not capable of blinding due to the need to perform a scalp biopsy for this group. N/A androgenic alopecia. Intervention 1: Intervention group: Patients who receive personalized MSCs extract. Intervention 2: Intervention group: patients who receive the non-personalized MSCs extract. Intervention 3: Control group: patients who receive placebo. Yes - There is a plan to make this available What will be shared: results of the main outcomes after de-identification of participants When: The access period starts 6 months after the results are published To whom: academic researcher Conditions: The request must be approved by Parsigene Company. Where to obtain: contact via email: parsigene@gmail.com How to obtain: Applicants will submit a personal resume and purpose of access to Parsigene Co. email address. the request will be reviewed within 3 weeks. Comments:
public Fatemeh Soleymani
Unit 6, No.132 , Vozara st
Tehran Iran (Islamic Republic of) 1516748617 +98 21 8866 2821 f.solimani@modares.ac.ir Faculty of Medical Sciences, Tarbiat Modares University scientific Mehrdad noruzinia
Unit6, No.132, Vozara st
تهران Iran (Islamic Republic of) 1516748617 +98 21 8670 5503 mehrdad.noruzinia@gmail.com Faculty of Medical Sciences, Tarbiat Modares University Iran (Islamic Republic of) Previous diagnosis of Androgenic alopecia. those who aged 18-59 years old. 18 years 59 years Both Medications or supplements intake that can affect hair growth. (including finasteride, or any other hormonal products) History of any surgical procedure on the scalp for the treatment of hair loss History of hyperthyroidism or hypothyroidism Current pregnancy or breastfeeding History of allergic reactions to topical medications L64 Androgenic alopecia N/A N/A N/A Intervention group: Patients who receive personalized MSCs extract Intervention group: patients who receive the non-personalized MSCs extract Control group: patients who receive placebo Number of hair in bald area. Timepoint: day 1, week 8th and week 16th;. Method of measurement: Phototrichogram (hair scanner). Hair diameter and Hair thickness. Timepoint: day 1, week 8th and week 16th;. Method of measurement: Phototrichogram (hair scanner). Pars igene Ltd. Co. Approved 2022-10-29 Research ethic committees Tarbiat Modares university Jalal AleAhmad , Nasr Tehran Tehran Iran (Islamic Republic of)