NCT00999115已完成1 期
Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in Crohn´s Disease
Fundacion para la Investigacion Biomedica del 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: 2009年9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
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed
研究概览
简要总结
The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Patients with Crohn´s disease diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomopathological and/or radiologic criteria.
- •Fulfilling one of the following criteria:
- •At least, one previous surgery for fistulous disease.
- •Physical status which discourage liposuction.
- •Rectovaginal fistula.
- •Women of a childbearing age. 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 (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease requiring immediate therapy, assessed by rectosigmoidoscopy
- •Patients with CDAI≥201
- •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 who have received infliximab or any other anti TNF agent in the 8 weeks before the cell treatment administration
- •Patients who have received tacrolimus or cyclosporine in the 4 weeks before the cell treatment administration
- •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 allergic to local anesthetics or gadolinium (MRI contrast) MRI is unfeasible (e.g. due to the presence of pacemakers, hip replacements or severe claustrophobia)
- •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 enrolment into this clinical trial, any investigational drug.
研究组 & 干预措施
Allogenic ASCs
Experimental
Intralesional dose of 20 million cells at baseline with a possible second administration of 40 million in case of incomplete fistula closure following week 12 assessment.
干预措施: Expanded allogenic adipose-derived adult stem cells (Drug)
结局指标
主要结局
Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed
时间窗: 12 weeks
次要结局
- Quality of life assessment using the SF-36 questionnaire(24 weeks)
- Adverse events(1, 4, 8,12, 24, 54 weeks)
- Clinically relevant variations in laboratory test(1, 4 8, 12, 24, 54 weeks)
研究者
Ignacio Galicia
Professor
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
研究点 (1)
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