Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks
研究概览
简要总结
Systemic sclerosis (SSc) is a rare autoimmune disease, mainly characterized by cutaneous and visceral fibrosis. Digital ulcer and sclerosing skin are commonly affected on hands, but the treatment for these manifestations are often ineffective.
Adipose tissue contains stromal vascular fraction (SVF), which is abundant multipotent stem cells, capable of tissue repair. A prior study (NCT01813279) has shown the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers in SSc.
There are only few ways to manage SSc patients with skin lesion who already have treated with several medications (including vasodilators, PDE5 inhibitor, endothelin receptor antagonist) but some times their skin lesions are critical physically and emotionally.
Autologous SVF injection could be one of the treatment options to treat skin lesion of SSc. Thus, the investigators study the efficacy and potential adverse event in Korean patients with SSc.
详细描述
In this study, the investigators will inject autologous Stromal vascular fraction.
- Acquiring autologous stromal vascular fraction by plastic surgeon
- Liposuction
- Extraction and purifying SVF using Smart-X system (15-20 min)
- Making syringe filled with autologous SVF
- SVF injection
Inject SVF subcutaneously with 25G needle in finger
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfill 2013 American college of Rheumatology/ European League Against Rheumatism Criteria for the classification of systemic sclerosis.
- •The skin lesion was not improved after 6 months treatment with conventional therapy.
排除标准
- •Start new medications within 3 months prior to enrollment
- •Previous sympathectomy or amputation
- •Current systemic infection
- •AIDS, Syphilis, hepatitis B&C
- •BMI <17kg/m2
- •Cognitive dysfunction and other psychologic problems
研究组 & 干预措施
Stromal vascular fraction injection
Injection of autologous stromal vascular fraction on hand.
干预措施: injection of autologous stromal vascular fraction (Biological)
结局指标
主要结局
Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks
时间窗: baseline, 12 weeks
Assess hands mRSS
次要结局
- Change from baseline Raynaud's condition score at 12 weeks(baseline, 12 weeks)
- Change from baseline Kapandji score at 12weeks(baseline, 12 weeks)
- Change from baseline Cochin hand function scale at 12 weeks(baseline, 12 weeks)
- Change from baseline peripheral vasculature at 12 weeks(baseline, 12 weeks)
- Changes from baseline mRSS (total) at 12 weeks(baseline, 12 weeks)
- Change from baseline Visual Analog Score for pain the hands at 12 weeks(baseline, 12 weeks)
- Change from baseline Systemic sclerosis HAQ at 12 weeks(baseline, 12 weeks)
- Change from baseline finger circumference at 12 weeks(baseline, 12 weeks)
研究者
Jung Hee Koh
Clinical Professor, Principal Investigator
The Catholic University of Korea