NCT01011244已完成2 期
A Phase II Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy
Anterogen Co., Ltd.2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Efficacy: complete closure of fistula at week 8
研究概览
简要总结
Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is high. On 15 October 2008, orphan designation was granted by Korea FDA for human adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to evaluate the safety and efficacy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years
- •Prior diagnosis of Crohn's disease
- •patients who have Crohn's fistula
- •negative for serum beta-HCG for woman of childbearing age
- •agreement to participate, with signed informed-consent
排除标准
- •patients who have allergy to bovine-derived materials or an anesthetic
- •patients with a diagnosis of auto immune disease except for Crohn's disease
- •Diagnosis of HBV, HCV, HIV and other infectious disease
- •Patients who have a symptom of septicemia
- •Patients with a diagnosis of active Tuberculosis
- •Patient who are pregnant or breast-feeding
- •Patients who are unwilling to use an "effective" method of contraception during the study
- •Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease
- •Patients who are sensitive to Fibrin glue
- •Patients who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker
- •Insufficient adipose tissue for manufacturing of ADIPOPLUS
- •Patients who are considered not suitable for the study by investigator
- •Patients with a diagnosis of active refractory Crohn's disease
- •Patients who have history of surgery for malignant cancer in the past 5 years
- •Patients who have > 2 cm diameter of fistula
结局指标
主要结局
Efficacy: complete closure of fistula at week 8
时间窗: 8 weeks
number of patients with any adverse event
时间窗: Day 0, Week 8
次要结局
- Photo of target fistula(8 weeks)
- number of patients with any adverse events(8 weeks)
- number of patients with complete closure of fistula(8 weeks)
- Investigator's satisfaction(8 weeks)
研究者
研究点 (2)
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