Burn Scar Clinical Trial
Official title:
Supplementation of Autologous Fat Grafts With Curcumin Preconditioned Adipose-Derived Stem Cells in the Treatment of Facial Contour Deformities
The aim of this study is to evaluate the comparison of therapeutic potential of curcumin preconditioned adipose derived stem cells (ASCs) enrichment fat grafting, naïve ASCs enrichment fat grafting and conventional fat grafting to correct facial contour deformities that cause aesthetic complications in patients.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | December 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion criteria - Age 18-50 years (male or female) - Body-mass index 20-30 kg/m² - Suitable for liposuction as assessed by the expected cosmetic results - Provided signed informed consent Exclusion criteria - Systemic disorders include autoimmune diseases, hemorrhagic diseases, bone marrow aplasia, sepsis, cancer, and others - Local disorders include acne, infections and others - Risk factors include smoking, uncompensated diabetes, hypertension, and allergy to the drugs used for general anesthesia - Microbiological contamination of either the cell culture or the transplanted tissue |
Country | Name | City | State |
---|---|---|---|
Pakistan | Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC) | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
University of the Punjab | Centre of Excellence in Molecular Biology, University of the Punjab, Lahore, Higher Education Commission (Pakistan), Jinnah Burn and Reconstructive Surgery Centre, Lahore |
Pakistan,
Bashir MM, Sohail M, Ahmad FJ, Choudhery MS. Preenrichment with Adipose Tissue-Derived Stem Cells Improves Fat Graft Retention in Patients with Contour Deformities of the Face. Stem Cells Int. 2019 Nov 20;2019:5146594. doi: 10.1155/2019/5146594. eCollection 2019. — View Citation
Cao Z, Li H, Wang ZH, Liang XQ. High-Density Fat Grafting Assisted Stromal Vascular Fraction Gel in Facial Deformities. J Craniofac Surg. 2022 Jan-Feb 01;33(1):108-111. doi: 10.1097/SCS.0000000000008038. — View Citation
D.A. Bourne, F.M. Egro, J. Bliley, I. James, G.L. Haas, E.M. Meyer, V. Donnenberg, A. Donnenberg, B. Branstetter, K. Marra, Abstract QS11: stem cell therapy enriched fat graft reconstruction of craniofacial deficits, Plastic and Reconstructive Surgery Global Open 6(4 Suppl) (2018).
Ghufran H, Mehmood A, Azam M, Butt H, Ramzan A, Yousaf MA, Ejaz A, Tarar MN, Riazuddin S. Curcumin preconditioned human adipose derived stem cells co-transplanted with platelet rich plasma improve wound healing in diabetic rats. Life Sci. 2020 Sep 15;257:118091. doi: 10.1016/j.lfs.2020.118091. Epub 2020 Jul 12. — View Citation
Matsumoto D, Sato K, Gonda K, Takaki Y, Shigeura T, Sato T, Aiba-Kojima E, Iizuka F, Inoue K, Suga H, Yoshimura K. Cell-assisted lipotransfer: supportive use of human adipose-derived cells for soft tissue augmentation with lipoinjection. Tissue Eng. 2006 Dec;12(12):3375-82. — View Citation
Wang C, Long X, Si L, Chen B, Zhang Y, Sun T, Zhang X, Zhao RC, Wang X. A pilot study on ex vivo expanded autologous adipose-derived stem cells of improving fat retention in localized scleroderma patients. Stem Cells Transl Med. 2021 Aug;10(8):1148-1156. doi: 10.1002/sctm.20-0419. Epub 2021 Apr 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Volumetric change in facial tissue by ultrasonography | Volumetric evaluation of treated area will be done by measuring the thickness of subcutaneous tissue (in millimeters) by using baseline B mode ultrasound device. Volumetric evaluation of treated area will be done by measuring the thickness of subcutaneous tissue (in millimeters) before transplantation, 1 week after transplantation then after 3, 6 and 9 months by using baseline B mode ultrasound device. | 9 months | |
Secondary | Patient Assessment | Patients will be interviewed and pre-and post-operatively and digital images will be taken until 9 months of follow up. | 9 months | |
Secondary | Surgeon Assessment | Patients will be visually inspected for facial volume by two qualified plastic surgeons unaware of treatment after grafting to check whether curcumin pretreatment have effect on MSCs origin of ASCs. | 9 months |
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