Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Disease)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- The volume change of fatty layer
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of adipose tissue derived mesenchymal stem cells (MSCs) in patient with progressive hemifacial atrophy.
详细描述
Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy.
With the recent demonstration of MSC homing properties, intramuscular aplications of MSCs to cell-damaged diseases have increased.
In a human clinical trial, five patients who had suffered a progressive hemifacial atrophy( Romberg's disease) were intramuscular administered autologous hAdMSCs (1×10e7 cells/500ul) with autologous microlipoinjection one time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who understand and sign the consent form for this study.
- •Age :18-75, males and females.
- •Patients with symptom of hemifacial atrophy but not progress disease.
排除标准
- •Patients with currently progressive hemifacial atrophy.
- •Women who are pregnant or breast feeding or planning to become pregnant during the study.
- •Subjects who don't understand purpose and method for this study.
- •Patients with psychical disorder or drug and alcohol addiction.
- •Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
- •Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.
- •Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
结局指标
主要结局
The volume change of fatty layer
时间窗: 24 weeks
To evaluate the volume change of fatty layer using 3D camera.
次要结局
- Clinical lab tests(24 weeks)
- Fat absorption rate(24 weeks)