NCT02328625撤回不适用
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (ADRCs) Registry
Cytori Therapeutics0 个研究点开始时间: 2015年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in Cochin score
研究概览
简要总结
This registry study will assess the safety and performance of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand scleroderma.
详细描述
This registry study will assess the safety and performance of the Celution System in preparation of adipose derived regenerative cells in the treatment of scleroderma affecting the hands. This will be a multi-center, multi-national study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Diagnosis of scleroderma and presence of hand scleroderma
- •Cochin score ≥ 20 units
排除标准
- •Body Mass Index < 17 kg/m2
- •Infection in any finger
- •Stable medications for the treatment of scleroderma for ≥ 1 month
- •Pregnant or lactating status.
结局指标
主要结局
Change in Cochin score
时间窗: Day 90
次要结局
- Raynaud's Condition Score(Days 7, 30, 90 and 180)
- EQ-5D(Days 7, 30, 90 and 180)
- Change in Cochin score(Days 30 and 180)
- Scleroderma Health Assessment Questionnaire (SHAQ)(Days 7, 30, 90 and 180)
- Physician and Patient Global Assessment(Days 7, 30, 90 and 180)
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