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IRCT20141007019432N2 IRCT 2018-01-11 Tehran University of Medical Sciences Efficacy assessment of cell therapy in skin aging Stromal Vascular Fraction (SVF) Evaluation efficiency of autologous Stromal Vascular Fraction (SVF) (Adiposin) transplantation in facial wrinkles 2017-12-22 anticipated 46 Complete https://irct.ir/trial/27971 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. 4 Atrophic disorders of skin (aging). Firstly biometric parameters of candidate face before intervention would be measured and then about 100cc of abdominal fat would be taken via liposuction technique being suspended and finally the suspension of adipose derived stem cells as in Stromal Vascular Fractioned(SVF) would be injected in patient facial wrinkle.. Undecided - It is not yet known if there will be a plan to make this available
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 and comply with the study requirements 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 sponsor'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 Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study 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 100cc of abdominal fat would be taken via liposuction technique being suspended and finally the suspension of adipose derived stem cells as in Stromal Vascular Fractioned(SVF) would be injected in patient facial wrinkle. Quantity of facial wrinkle - Extension. Timepoint: 1- 3 - 6 Month after cell therapy. Method of measurement: Biometry with visioface & skin sonography. Quality of facial wrinkle - deep. Timepoint: 1 - 3 - 6 Month after intervention. Method of measurement: Biometry with visioface & skin sonography. Color. Timepoint: 1 - 3 - 6 Month after cell therapy. Method of measurement: Biometry with colorimeter. Elastisity. Timepoint: 1 - 3 - 6 Month after cell therapy. Method of measurement: MPA 9. Sinacell Corporation Tehran University of Medical Sciences Sinacell Corporation Approved 2017-11-29 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)