The Improving Effect of Autologous Stromal Vascular Fraction (SVF) in Adipose Tissue on Skin Grafting
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|ClinicalTrials.gov Identifier: NCT02546882|
Recruitment Status : Unknown
Verified September 2015 by Qing-Feng Li, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : September 11, 2015
Last Update Posted : September 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Skin; Deformity, Due to Scar||Biological: stromal vascular fraction Drug: saline||Phase 1 Phase 2|
Reconstruction of large scale skin defect is still a challenge for clinical surgeons. The application of skin grafting works as an important choice, however, the strong contracture and poor appearance limit its wide application in scar repair. The stromal vascular fraction (SVF) of adipose tissue is a group of heterogeneous cells including multipotential mesenchymal cells, preadipocytes, endothelial cells, fibroblasts, macrophages and smooth muscle cells. Previous researches have reported that SVF could secrete various angiogenic growth factors in vitro and enhance neovascularisation of ischaemic tissue in vivo. The Adipose-derived Stem cells in the SVF are multipotential stem cells which have the ability to regenerate, while differentiating to become adipose tissue and help to improve the texture of the grafted skin. Besides, SVF is easy to be harvested in large numbers with less donor injury and can be used directly after isolation without in vitro culture, which makes it a good alternative for regenerative medicine.This study is to observe the effect of autologous SVF on improving the texture and contracture of skin grafting.
Patients requiring skin graft of 2 symmetry parts of the body between the age of 3 and 70 years will be enrolled and randomized into two groups, named as the experimental group with SVF transplantation and the control group with no cell transplantation. Patients from the experimental group will have a fat aspiration on the surgery day. The adipose tissue in abdomen or thigh will be digested at 37 °C for 60 min with 0.2% collagenase IV. After filtration and centrifugation, mature adipocytes are separated from the cell pellet. The pellet then is treated with erythrocyte lysis buffer twice to remove red cell fragment. The harvested pellet is SVF. The SVF will be resuspended in saline and transplanted between the grafted skin and the wound with 1 million cells for 1 cm2 area. Skin thickness, texture, contracture and colour will be observed to measure the effect of SVF on skin grafting post treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 1/2 Study of Autologous Stromal Vascular Fraction in Adipose Tissue Transplantation in Improving Skin Grafting|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: stromal vascular fraction
The adipose tissue in abdomen or thigh will be harvested and digested at 37 °C for 60 min with 0.2% collagenase I/Ⅲ. After filtration and centrifugation, mature adipocytes are separated from the cell pellet. The pellet then is treated with erythrocyte lysis buffer twice to remove red cell fragment. The harvested pellet is stromal vascular fraction (SVF).
Biological: stromal vascular fraction
1million stromal vascular fraction was resuspended in 1 ml saline and transplanted for 1 cm2 area.
Other Name: heterogeneous cell populations isolated from adipose tissue
Placebo Comparator: saline
1 ml saline without cells will be used as placebo.
1 ml saline was injected for 1 cm2 area.
Other Name: normal saline
- Measure the texture and colour change of the skin using Cutometer® dual MPA 580 and questionnaires in 6 months post the treatment. [ Time Frame: 6 months post the treatment. ]Questionnaires scores satisfaction range from 0(not satisfied with the result) to 10(good result)
- Occurence of major adverse events [ Time Frame: Up to approximately 18 months after study start ]Including skin graft ischaemia, necrosis, infection, and all other adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546882
|Contact: Qingfeng Li, MD, PhD||0086 21 email@example.com|
|Contact: Hua Li, MD, PhD||0086 firstname.lastname@example.org|
|Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200011|
|Contact: Qingfeng Li, MD, PhD 0086 21 63089567 email@example.com|
|Contact: Hua Li, MD, PhD 0086 18621871963 firstname.lastname@example.org|
|Principal Investigator: Qingfeng Li, MD,PhD|
|Sub-Investigator: Hua Li, MD, PhD|
|Sub-Investigator: Xiyuan Mao, MM|
|Sub-Investigator: Chen Cheng, MD|
|Study Director:||Qingfeng Li, MD, PhD||Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine|