NCT01801878撤回不适用
Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure
研究概览
简要总结
The aim of this study is to evaluate the skin quality of using adipose-drived stromal vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation system into irradiated breasts.
详细描述
10 participants who taken conservative mastectomy will be enrolled
- Process
- adipose tissue is obtained from the subject's thigh or abdomen
- adipose-drived stromal vascular fraction(SVF)cell isolation using automatic centrifuge system
- adipose-drived stromal vascular fraction(SVF)cell graft into the irradiated breast.
- Duration of study
- entire duration: approximate 30weeks
- Follow-up period: 12 weeks
- Enrollment period: 12 weeks
- Study design - Randomized, prospective, pilot study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged between 40 and 60
- •Subjects who diagnosed breast ductal carcinoma in situ of surgical staging T1aN0, negative resection margin of below 2mm in histopathologic examination
- •Subjects who have a relapse-free interval of more than one year after breast-conserving surgery for breast cancer and radiation therapy
- •Subjects who understand the study contents and sign the informed consent
排除标准
- •Subjects who have radiodermatitis
- •Subjects who planned breast reconstruction with autogenous tissue (ex.Transverse Rectus Abdominis Muscle flap)
- •Subjects who have a history of smoking within 3months recently
- •Subjects who participated in other clinical trial within 30 days recently
- •Pregnant or lactating subjects
- •Subjects who have a active infectious disease
- •Subjects who are not eligible for this study at the discretion of the investigator
研究组 & 干预措施
Adipose SVF cell
Experimental
adipose SVF cell transfer to the half of irradiated breast
干预措施: Adipose SVF cell (Biological)
Normal saline
Active Comparator
Normal saline inject to the half of irradiated breast
干预措施: Normal saline (Biological)
结局指标
主要结局
The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure
时间窗: change in the breast skin thickness from baseline at 12 week
The efficacy is assessed by breast skin thickness measured by radiologist using breast ultrasonography
次要结局
未报告次要终点
研究者
研究点 (1)
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