Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 174
- 主要终点
- Cochin Hand Function Score
研究概览
简要总结
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.
详细描述
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.
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)
盲法说明
Placebo is visually indistinguishable from active treatment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diffuse cutaneous scleroderma (duration > 5 years)
- •Cochin Hand Function Scale ≥ 20 units
- •Symptoms consistent with Raynaud's Phenomenon
- •Ability to safely undergo liposuction
排除标准
- •Active infection
- •Contracture(s) of any finger
- •Sympathectomy within 6 months of Screening Visit
- •Rheumatoid Arthritis
研究组 & 干预措施
ADRC Arm
Subjects in the ADRC arm will receive standard care and active treatment (ADRCs)
干预措施: ADRCs (Device)
ADRC Arm
Subjects in the ADRC arm will receive standard care and active treatment (ADRCs)
干预措施: Standard Care (Other)
Standard Care Arm
Subjects in the Standard Care arm will receive standard care and Placebo
干预措施: Standard Care (Other)
Standard Care Arm
Subjects in the Standard Care arm will receive standard care and Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Cochin Hand Function Score
时间窗: 26 weeks
Cochin Hand Function Score
次要结局
未报告次要终点