NCT01440699已完成1 期
Phase I Study of Dose Escalation of Human Allogenic Adipose-derived Stem Cells (ALLO-ASC) to Evaluate Safety and Efficacy in Patients With Crohn's Fistula
Anterogen Co., Ltd.3 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- General safety (Laboratory screening, adverse effects, immunological response, local tolerance)
研究概览
简要总结
Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.
Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in Phase I and II study on the patients with Crohn's fistula.
However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and efficacy in patients with Crohn's fistula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Crohn's disease
- •Crohn's fistula which has been lasted at least for 3 months
- •Negative for beta-HCG pregnancy test
排除标准
- •Medical history with Variant Creutzfeldt Jacobs Disease
- •Allergic to anesthetics or bovine protein or fibrin glue
- •autoimmune disease other than Crohn's disease
- •Infectious disease
- •Sepsis or active tuberculosis
- •pregnant or breast feeding woman
- •Inflammatory Bowel disease other than Crohn's disease
- •active crohn's disease with CDAI score > 200
- •malignant tumor
- •fistula's diameter > 2 cm
结局指标
主要结局
General safety (Laboratory screening, adverse effects, immunological response, local tolerance)
时间窗: Week8
次要结局
- Proportion of patients with sustained efficacy(Month 8)
- Proportion of patients with adverse effects(at month 8)
研究者
研究点 (3)
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