NCT01011686终止1 期
A Phase I Clinical Study of ANT-SM (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Fecal Incontinence to Evaluate Safety
Anterogen Co., Ltd.2 个研究点 分布在 1 个国家开始时间: 2009年11月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 试验地点
- 2
- 主要终点
- Efficacy: Wexner's score evaluation
研究概览
简要总结
Fecal incontinence affects 18.4% adults in the community and greatly impacts quality of life. There's a problem like inconvenience, pain or allergic response in many therapeutic methods such as a surgical operation or material injection. ANT-SM is autologous adipose-derived stem cell, and so, expect of no immune responses. In this study, patients are given injection of ANT-AM in anal sphincter and followed for 4 weeks to test the safety.
研究设计
- 研究类型
- Interventional
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
- •Wexner's fecal incontinence score > or egal 5
- •patient who has fecal incontinence for more than 6 months
- •Continuity of anal sphincter at endorectal ultrasound and abnormality of anal function at anorectal manometry
- •negative for urine beta-HCG for woman of childbearing age
- •agreement to participate, with signed informed-consent
排除标准
- •Anorectal surgery within the last 6 months prior to the study
- •patient who is allergy to bovine-derived materials and an anesthetic
- •patients with a diagnosis of auto immune disease
- •Diagnosis of HBV, HCV, HIV and other infectious disease
- •Patients with a diagnosis of active Tuberculosis
- •Patient is pregnant or breast-feeding
- •Women within 6 months post partum
- •Patient who is unwilling to use an "effective" method of contraception during the study
- •Patients with a diagnosis of Inflammatory Bowel Disease
- •Patient who has a clinically relevant history of abuse of alcohol or drugs
- •Insufficient adipose tissue for manufacturing of ANT-SM
- •Patient whom investigator consider is not suitable in this study
- •Patients have history of surgery for malignant cancer in the past 5 years
- •Patient who has to undergo ano-rectal surgery
- •Patient who has a history of artificial anal sphincter surgery
- •Patient who has taken cytotoxic drugs within the last 30 days
- •Patient whom investigator consider is not suitable in this study reasons for severe ano-rectal disease, severe constipation, fistula, rectal prolapsed or neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease)
结局指标
主要结局
Efficacy: Wexner's score evaluation
Safety: Clinically measured abnormality of laboratory tests and adverse events
次要结局
- Anorectal manometry and endorectal ultrasound at week 4
研究者
研究点 (2)
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