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IRCT20141007019432N3 IRCT 2018-01-12 Tehran University of Medical Sciences Efficacy assessment of cell therapy in skin aging Evaluation efficiency of autologous fibroblast (Cell fibrosin) transplantation in facial wrinkles 2017-12-22 anticipated 46 Complete https://irct.ir/trial/27899 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. 2-3 Atrophic disorders of skin (aging). Firstly biometric parameters of candidate face before intervention would be measured and then about 0.5 cm2 of skin biopsy from behind the ear would be taken via puncher. Fibroblast cells isolated and cultured in laboratory. Cell suspension of fibroblast cells would be injected in candidate facial wrinkle. After 1,3,6 month from injection, biometric parameters will be assessed for second time to estimate healing rate.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there are no more information
public Mahsa Mollapour
Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2220 1710 Mahsamollapur@yahoo.com Tehran University of Medical Sciences scientific Dr. Mohammadali Nilforoushzade
Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2220 1710 dr_nilforoush@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) age about 35 to 65 years old Having no anatomic disorder in face Wrinkle type between grade 2 to 4 Normal mental health Ability to comply with the study requirements Provide written informed consent Negative pregnancy test (Females) 35 years 65 years Both being smokers or drinkers any past skin intervention in face Having many wrinkles on the face type of 1 or 5 of wrinkle scoring having a mental disorder Previous treatment with the filler's product History of active autoimmune disease or organ transplantation Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded) Active or chronic skin disease Known genetic disorders affecting fibroblasts or collagen Active systemic infection Requires chronic antibiotic or steroidal therapy Known allergic reactions to agents used in preparation of treatment Excessive exposure to sun without adequate sun protection Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects Z68.53 Atrophic disorder of skin Other Firstly biometric parameters of candidate face before intervention would be measured and then about 0.5 cm2 of skin biopsy from behind the ear would be taken via puncher. Fibroblast cells isolated and cultured in laboratory. Cell suspension of fibroblast cells would be injected in candidate facial wrinkle. After 1,3,6 month from injection, biometric parameters will be assessed for second time to estimate healing rate. Quantity of facial wrinkle - Extension. Timepoint: Months: 1, 3 and 6 after cell therapy. Method of measurement: Biometry with visioface & skin sonography. Quality of facial wrinkle - deep. Timepoint: Months: 1, 3 and 6 after cell therapy. Method of measurement: Biometry with visioface & skin sonography. Color. Timepoint: Months: 1, 3 and 6 after cell therapy. Method of measurement: Biometry with colorimeter. Elastisity. Timepoint: Months: 1, 3 and 6 after cell therapy. Method of measurement: MPA 9. Sinacell Corporation Tehran University of Medical Sciences Sinacell Corporation Approved 2017-11-25 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Cross Qods st, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)