NCT01584713Unknown1 期
A Phase II Clinical Trial to Study the Feasibility and Safety of Stromal Vascular Derived From Adipose Tissue for the Treatment of Enterocutaneous Fistula
Instituto de Investigación Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety of treatment of treated enterocutaneous fistulae. Percentage of treated subjects with closed fistulae
研究概览
简要总结
The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of enterocutaneous fistula.
详细描述
SF-12 Test
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
- •Signed informed consent
- •Enterocutaneous fistula
- •Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
排除标准
- •Presence of severe proctitis or dominant active luminal disease requiring immediately therapy
- •Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
- •Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
- •Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
- •Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
- •Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
- •Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
- •Patients who have suffering major surgery or severe trauma in the prior 6 months
- •Pregnant or breastfeeding women
- •Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.
研究组 & 干预措施
Adipose derived Stem Cells
Experimental
干预措施: Adipose-derived stem cells without expanded (Drug)
结局指标
主要结局
Safety of treatment of treated enterocutaneous fistulae. Percentage of treated subjects with closed fistulae
时间窗: 16 weeks
Safety by analyzing the number of adverse effects associated with experimental treatment.
次要结局
- quality of life test(16 week)
- First efficacy data(16 weeks)
研究者
研究点 (1)
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