NCT00992485已完成1 期
A Phase I Dose Escalation 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.1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events
研究概览
简要总结
Up to date, a sure cure for Crohn's fistula has not known and the fistula recurrence rate is high. On 15 October 2008, orphan drug designation was granted by Korea FDA to Anterogen Co. Ltd., for human adipose-derived stem cell. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to test 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 urine 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
- •Patients 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 is sensitive to Fibrin glue
- •Patients who have a clinically relevant history of abuse of alcohol or drugs
- •Insufficient adipose tissue for manufacturing of ADIPOPLUS
- •Patients who are considered not suitable for the study by investigator
- •Patients who have history of surgery for malignant cancer in the past 5 years
研究组 & 干预措施
autologous adipose derived stem cell
Experimental
干预措施: ADIPOPLUS (Drug)
结局指标
主要结局
Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events
次要结局
- Closure of fistula(week 4)
- Investigator satisfaction(week 4 and week 8)
- Patient satisfaction(week 4 and week 8)
- Digital photography(day 1, week 4 and week 8)
研究者
研究点 (1)
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