NCT01586715Unknown2 期
A Phase IIa Clinical Trial to Study the Treatment of the Extremely Complex and Conventional Treatment Resistant Perianal Fistulae With Autologous Stem Cells From Lipoaspirate
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety of treatment of extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae
研究概览
简要总结
The purpose of this study is to evaluate the practicability of the autologous e-ASC (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant perianal fistulae.
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
- •Extremely Complex perianal fistulae
- •Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
- •Previous failure in at least one closing fistula standard treatment
排除标准
- •Presence of severe proctitis or dominant active luminal disease requiring immediate 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
Autologous 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 extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae
时间窗: 16 weeks
Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound
次要结局
- Quality of life assessment using the SF-12 Questionnaire(1, 4, 16,24 weeks)
- Adverse events(1, 4, 12, 24 weeks)
研究者
研究点 (1)
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