Phase 1/2 Study of Autologous Stromal Vascular Fraction in Adipose Tissue Transplantation in Improving Skin Grafting
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Measure the texture and colour change of the skin using Cutometer® dual MPA 580 and questionnaires in 6 months post the treatment.
研究概览
简要总结
The purpose of this study is to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving the texture and contracture of skin grafting.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With symmetrical scar or soft tissue deficiencies requiring skin graft therapy.
- •Age of 3 to
- •Have no underlying disease except skin scar deformity.
- •Have enough healthy donor site skin for both sides of receiving area.
排除标准
- •Not fit for skin graft treatment;
- •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.
研究组 & 干预措施
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).
干预措施: stromal vascular fraction (Biological)
saline
1 ml saline without cells will be used as placebo.
干预措施: saline (Drug)
结局指标
主要结局
Measure the texture and colour change of the skin using Cutometer® dual MPA 580 and questionnaires in 6 months post the treatment.
时间窗: 6 months post the treatment.
Questionnaires scores satisfaction range from 0(not satisfied with the result) to 10(good result)
次要结局
- Occurence of major adverse events(Up to approximately 18 months after study start)
研究者
Qing-Feng Li
MD, PhD, Professor, Head of the Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital
Shanghai Jiao Tong University School of Medicine