NCT00953485Unknown1 期
Clinical Trial of Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome - Phase Ⅰ/Ⅱ
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Sjögren's syndrome disease activity index
研究概览
简要总结
This study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) to treat patients with diagnosis of primary Sjögren's Syndrome (pSS) who have been resistant to multiple standard treatments. The underlying hypothesis is that the pSS condition is caused by an abnormal immune homeostasis that can be restored by MSCT.
详细描述
- To test a new approach using allogeneic derived mesenchymal stem cell based therapy (MSCT) to treat refractory primary Sjögren's Syndrome (pSS)
- To determine the disease-free survival in pSS patients treated with MSCT in terms of disease activity index, pSS serology and salivary gland function
- To assess adverse events of allogeneic MSC transplantation
- To assess the association of disease activity index, pSS serology levels, and saliva flow rate at baseline with disease-free survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients fulfilled the international classification criteria (2002) for primary Sjögren's Syndrome, man or woman aged from 15 to 70 years old, Sjögren's Syndrome Disease Activity Index (SSDAI)≥
- •Stimulated whole saliva flow rate less than 1~6ml/6min.
- •Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.
- •Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial and for 12 months following treatment. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment.
排除标准
- •End-stage renal failure.
- •Severe cardiopulmonary compromise, or other system failure.
- •Active, uncontrolled infections.
- •Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.
结局指标
主要结局
Sjögren's syndrome disease activity index
时间窗: Monthly
次要结局
- pSS Serology (ANA, dsDNA, SS-A, SS-B)(Monthly)
- Improvement of salivary gland function (measured as stimulated saliva flow rate)(Monthly)
研究者
研究点 (1)
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