NCT01803347已完成3 期
Multicentre,Randomized,Comparative,Add-on,Into Two Parallel Groups Clinical Trial to Evaluate Efficacy and Safety of Autologous Mesenchymal Stem Cells Derived From Expanded Adipose Tissue (ASC), for Treatment of Complex Perianal Fistulizing Disease in Patients Without IBD.
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz5 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Safety/efficacy
研究概览
简要总结
Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery
详细描述
Study of efficacy of adipose derived mesenchimals stem cells and surgery to treat complex perianal fistula
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
- Double (Participant, Outcomes Assessor)
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
- •Signature of informed consent.
- •Complex perianal fistula cryptoglandular. Understood as a fistula in which at least one of the following circumstances is present:
- •some degree of fecal incontinence associated
- •extrasphinterics fistulas,
- •fistulas supraresfinterianas
- •high transsphincteric fistulas.
- •Patients of both genders, with more that 18 years.
- •Good overall health, according to data from the clinical history and physical examination.
排除标准
- •Patient diagnosed with inflammatory bowel disease.
- •Subjects with abscess, except if a complete cleaning of the drainage area of collections is performed and the absence of abscess and other collections larger than 2 cm in maximum diameter before treatment is started is confirmed.
- •History of alcohol or substance abuse in the 6 months prior to inclusion.
- •Malignancy, except in the case of basal cell carcinoma or squamous cell skin or a history of malignancy, unless they have been found in remission during the previous 5 years.
- •medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study.
- •Subjects with congenital or acquired immunodeficiencies. Treponema, Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion.
- •Major surgery or severe trauma of the subject in the previous semester.
- •Pregnant or lactating women.
- •Adult women of childbearing potential not using effective contraception during the trial.
- •Administration of any investigational drug at present to three months prior to enrollment for this trial.
研究组 & 干预措施
Fibrin glue
Active Comparator
Intervention: fibrin glue Fibrin glue: Subjects will be treated with a dose fibrin glue plus a deep curettage and closure of the internal orifice, and evaluated after 16 weeks. If needed a second dose of fibrin glue will be applied then.
干预措施: fibrin glue (Drug)
结局指标
主要结局
Safety/efficacy
时间窗: 2014, march
Closure of fistulas defined as absence of suppuration and re-epithelization of the external opening and absence of collections\>2 cm directly related to the fistula tract treated, as measured by MRI (healing) \[ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose \]
次要结局
- Safety/efficacy(2015, march)
研究者
研究点 (5)
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