The Improving Effect of Autologous Stromal Vascular Fraction (SVF) in Adipose Tissue on Skin Grafting
NCT ID: NCT02546882
Last Updated: 2015-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
75 participants
INTERVENTIONAL
2015-02-28
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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).
stromal vascular fraction
1million stromal vascular fraction was resuspended in 1 ml saline and transplanted for 1 cm2 area.
saline
1 ml saline without cells will be used as placebo.
saline
1 ml saline was injected for 1 cm2 area.
Interventions
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stromal vascular fraction
1million stromal vascular fraction was resuspended in 1 ml saline and transplanted for 1 cm2 area.
saline
1 ml saline was injected for 1 cm2 area.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age of 3 to 70.
* Have no underlying disease except skin scar deformity.
* Have enough healthy donor site skin for both sides of receiving area.
Exclusion Criteria
* Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for skin grafting; or history of delayed healing, radiational therapy;
* Significant renal, cardiovascular, hepatic and psychiatric diseases;
* Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
* BMI \>30;
* Alcohol abuse
* History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
* Evidence of malignant diseases or unwillingness to participate.
3 Years
70 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Guangzhou General Hospital of Guangzhou Military Command
OTHER
Second Affiliated Hospital of Suzhou University
OTHER
The First People's Hospital of Zhaoqing City
UNKNOWN
Wuhan Third Hospital
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Qing-Feng Li
MD, PhD, Professor, Head of the Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital
Principal Investigators
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Qingfeng Li, MD, PhD
Role: STUDY_DIRECTOR
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Locations
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Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Qin J, Cheng C, Huang RL, He J, Zhou S, Tan PC, Zhang T, Fang B, Li Q, Xie Y. Isolation of the Stromal Vascular Fraction Using a New Protocol with All Clinical-Grade Drugs: From Basic Study to Clinical Application. Aesthetic Plast Surg. 2024 Nov;48(22):4702-4711. doi: 10.1007/s00266-024-04221-9. Epub 2024 Jul 10.
Other Identifiers
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2012BAI11B03
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2012BAI11B03
Identifier Type: -
Identifier Source: org_study_id
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