NCT01314092终止2 期
Phase II Study to Evaluate Efficacy and Safety of ANTG-ASC (Autologous Cultured Adipose-derived Stem Cells) on the Complex Fistula Patients
Anterogen Co., Ltd.8 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Number of patients with complete closure of fistula (week 8)
研究概览
简要总结
Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.
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
- Single (Participant)
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
- •a patient who has complex perianal fistula
- •a patient who is negative in pregnancy test
- •a patient who has submitted a written consent
排除标准
- •a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs.
- •a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
- •a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
- •a patient who has an autoimmune disease
- •a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- •a patient who has sepsis or active tuberculosis
- •a patient who is pregnant or breast feeding
- •a patient who has inflammatory Bowel disease
- •over 2cm in diameter of fistula
结局指标
主要结局
Number of patients with complete closure of fistula (week 8)
时间窗: 8 weeks
Proportion of patients with completely closed fistula (week 8)
次要结局
- Grade of investigator's satisfaction(8 weeks)
- Number of patients with closed fistula(8 weeks)
- Photo of target fistula(8 weeks)
- Number of patients with adverse events(8 weeks)
研究者
研究点 (8)
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