NCT00962923Unknown1 期
Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)
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8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
- mRSS score,HRQOL score, SF-36 score for SSc patients
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 systemic sclerosis(SSc) who have been resistant to multiple standard treatments. The underlying hypothesis is that the SSc 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 SSc
- To determine the disease-free survival in SSc patients treated with MSCT
- To assess adverse events of allogeneic MSC transplantation
- To assess the association of remission for organ function, clinical score and SSc serology levels 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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients fulfilled the American College of Rheumatology (former American Rheumatism Association - ARA) for SSc
- •Rapidly progressive disease <2 years duration with a modified Rodnan skin score(mRSS) above 20, plus ESR >25 mm/first h and/or Hb <11 g/dL, not explained by other causes than active SSc
- •lung involvement: with a vital capacity (VC) or DLCO below 70% predicted, or a mean pulmonary artery pressure (PAP) above 40 mmHg (measured by echocardiography)
- •digestive tract involvement: with serum albumin ,25 g/L or weight loss exceeding 10% body weight in the preceding year
- •kidney involvement: with 24-h urinary protein above 0.5 g or serum creatinine above 120 mmol/L
排除标准
- •Uncontrolled arrhythmia, echocardiographic left ventricular ejection fraction (LVEF) <50% or mean PAP >50 mmHg, DLCO<45% of predicted
- •Creatinine clearance <20 ml/min
- •Platelets<80 000/mm3, haemorrhagic cystitis
- •(4) HIV or HTLV1 seropositivity, malignancy, pregnancy, a cardiac or vascular prosthesis, and no vascular access
结局指标
主要结局
mRSS score,HRQOL score, SF-36 score for SSc patients
时间窗: monthly
次要结局
- Remission for organ function, VC, DLCO, PAP, serum albumin, serum creatitin, weight loss, 24h proteinuria(every three month)
- SSc Serology(ATA,ACA,ANA,anti-ssDNA,anti-dsDNA,IgM,IgG,and IgA,complement C3 and C4(every three month)
- Change of peripheral blood B and T cells(every three month)
研究者
研究点 (1)
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