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IRCT20210612051545N3 IRCT 2022-09-20 Tehran University of Medical Sciences human placenta in the treatment of skin wrinkles evaluation of human placenta extract effectiveness in the treatment of skin wrinkles: A phase I/II clinical trial 2022-09-23 anticipated 20 Complete https://irct.ir/trial/65749 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple; Randomization unit: individual; randomization does not have a layer. Randomization tool: table of random numbers. Concealment: Cellular and non-cellular product is delivered to the doctor in the form of a code and given to the patient based on the randomization table, Blinding description: Randomization master sheet Based on the random sequence of anonymous 4-digit codes, they are generated on the sealedenvelope.com website and attached to the products as labels. In the same way, it is sent to the study site. The randomization table is strictly confidential and will only be available to the clean room manager. Patients, as well as doctors and statisticians, will not know the type of treatment received. In CRF (Case Report Form) of patients 4 digits of the product code and 4 digits of the code are registered with the first two letters of the patient's name and surname. The 8-digit codes are transferred to the data bank, and then the list of 8-digit codes in the two groups receiving cells and placebo is given to the data management team in a blinded form in columns A and B. Also, the results of additional paraclinical studies The treating physician will be evaluated by another specialist physician who is not aware of the treatment process. 1-2 skin wrinkles. Intervention 1: Intervention group: Intervention group: local transplantation of hydrogel derived from decellularized extracellular matrix (ECM) of the umbilical cord was designed in 10 candidates with wrinkles. 3 times of hydrogel derived from decellularized extracellular matrix (ECM) at an interval of 2 weeks is injected. Follow-up is done in the 1st and 2nd week and in the 2nd, 4th and 6th months after the injection. Intervention 2: Control group: In 10 candidates with wrinkles, 3 times of physiologic serum at an interval of 2 weeks is injected. Fallow up is done in the 1st and 2nd week and in the 2nd, 4th, and 6th months after the injection. Yes - There is a plan to make this available What will be shared: All data can be shared after blinding the individuals When: 6 months after publishing the manuscript To whom: Academic researchers Conditions: In order to analyze the data related to the study outcome Where to obtain: Amir bajouri bajouri.md@gmail.com How to obtain: After reviewing in the Research Council of University of Medical Sciences can be presented which usually takes 1 to 2 months Comments:
public Amir Bajouri
No 4 Maryam Dead End South Andarzgo Blvd، Kamraniyeh
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7541 bajouri.md@gmail.com Tehran University of Medical Sciences scientific Mohammad Ali Nilforoushzadeh
No 4 Maryam Dead End South Andarzgo Blvd، Kamraniyeh
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7541 nilforoushzadeh@mui.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Wrinkle lines on the face should be in the range of 3-5 based on Wrinkle Severity Rating Scale 35 years 65 years Both Suffering from uncontrolled chronic diseases including diabetes mellitus, underlying chronic liver, kidney and heart disease, chronic malnutrition, malignancy, coagulopathy or the use of anticoagulants, a history of autoimmune diseases and suffering from HBV, HIV, HCV viral infections Any cosmetic procedure such as fat injection within a year and permanent filler, microneedling, RF, laser and other cases within the last 6 months, except for using cream. Infection and any malignancy at the transplant recipient site Failure to receive cells in the treatment area during the past year Patients with vitiligo Moderate to severe chronic skin diseases such as eczema and psoriasis active acne People who have had systemic retinoid treatment (within the last 6 months) or topical retinoid treatment (within the last 2 weeks History of keloid Women during pregnancy and breastfeeding Patients undergoing radiotherapy and chemotherapy L98.8 Other specified disorders of the skin and subcutaneous tissue Treatment - Other Treatment - Other Intervention group: Intervention group: local transplantation of hydrogel derived from decellularized extracellular matrix (ECM) of the umbilical cord was designed in 10 candidates with wrinkles. 3 times of hydrogel derived from decellularized extracellular matrix (ECM) at an interval of 2 weeks is injected. Follow-up is done in the 1st and 2nd week and in the 2nd, 4th and 6th months after the injection. Control group: In 10 candidates with wrinkles, 3 times of physiologic serum at an interval of 2 weeks is injected. Fallow up is done in the 1st and 2nd week and in the 2nd, 4th, and 6th months after the injection Absence of side effects, including short-term and long-term, systemic or local side effects, and severe or mild side effects in the treatment with hydrogel derived from decellularized umbilical cord ECM (zero and 2 weeks, 1, 2, 4 and 6 months after first injection) through clinical examination and CTCAE v5 review. Timepoint: zero and 2 weeks, 1, 2, 4 and 6 months after first injection. Method of measurement: Wrinkle reduction based on WSRS score reduction six months after injection. Reduction of wrinkles based on the increase in GAIS score two weeks, 1, 4, and 6 months after the first injection). Vira Cellule Co Approved 2022-08-30 Ethics committee of Tehran University of Medical Sciences No 4 Maryam Dead End South Andarzgo Blvd، Kamraniyeh Tehran Tehran Iran (Islamic Republic of)