NCT02622763终止1 期
Safety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's Disease
Fundacion Clinic per a la Recerca Biomédica2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of adverse events
研究概览
简要总结
Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.
详细描述
The main objective is to evaluate the safety and clinical response of intralesional injection of Autologous peripheral blood differentiated adult dendritic cells expanded tolerogenic in patients with refractory Crohn's disease treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Crohn's disease ( Lennard -Jones criteria )
- •Active Crohn's disease in the last six months to the inclusion defined as : CDAI? 220 and endoscopic or radiological criteria of activity
- •Refractory or intolerance to conventional therapy including corticosteroids , immunomodulators and anti-tumor necrosis factor-alpha
- •Presence of visible lesions by endoscopy
- •Acceptance to participate in the study and written informed consent
排除标准
- •No injuries in pre-screening resonance
- •Pregnancy, lactation or women of childbearing age not taking appropriate contraceptive measures
- •Patients HIV + and Hepatitis C Virus + Hepatitis B Virus +
- •Serious concomitant disease:
- •Renal failure with creatinine clearance < 40ml / min
- •Heart disease: congestive heart failure with ejection fraction < 45 % , atrial fibrillation treated with oral anticoagulants, uncontrolled ventricular arrhythmias , pericarditis , pleural effusion with hemodynamic
- •Neoplasms or myelodysplasia
- •Psychiatric disorders including alcohol and drugs
- •Symptoms attributable to fibrotic strictures in Crohn's disease at the discretion of the investigators
- •Diarrhea attributable to " short bowel syndrome"
- •Active infection , including tuberculosis
- •Participation in research studies of new drugs in the 3 months prior to inclusion.
- •Vaccination with live/attenuated germs in the previous 3 months
- •Personal history of cancer (active or complete remission) or known family history of hereditary cancer.
- •Patients in whom , after observation of the state of their veins , these are considered inaccessible and impossible to perform apheresis
结局指标
主要结局
Number of adverse events
时间窗: from inclusion up to 12 weeks
Proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points
时间窗: up to 12 weeks
次要结局
- The proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points(from baseline to week 12)
- The proportion of patients in clinical remission defined as Crohn 's Disease Activity Index < 150 points(at week 12)
- Endoscopic lesions using the Crohn 's Disease Endoscopic Index of Severity ". Endoscopic remission was defined as the absence of ulcers(at baseline and week 12)
- The evaluation of quality of life will be held by Inflammatory bowel disease questionnaire Immunological endpoints(Change from baseline to week 12)
研究者
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica
研究点 (2)
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