EUCTR2012-002685-12-DE进行中（未招募）1 期
Treatment of steroid resistant severe acute gastrointestinal graft-versus-host disease with in vitro expanded donor-derived regulatory T cellsA prospective open-label one-armed non-randomized multicenter early phase II proof of principle study - Treg Therapy
niversity Hospital Regensburg0 个研究点目标入组 29 人开始时间: 2012年10月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Histology-proven GVHD
- •- Clinical stage 2-4 acute gastrointestinal GVHD with or without other GVHD manifestations (overall GVHD grade III-IV)
- •- Disease resistance to steroid treatment (at least 1 mg/kg bw) - Male and female patients, age 18 - 70y
- •- Written informed consent of patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •- Age <18 y and >70 y
- •- No previous steroid therapy (first-line treatment)
- •- No previous second-line therapy
- •- Severe psychiatric disorders
- •- Presumed life expectancy < 4 wks
- •- Lack of informed consent
- •- Pregnant or nursing woman
- •- Patients included in other clinical trials interfering with the present study
- •- Donors from outside EU
研究者
相似试验
进行中（未招募）
1 期
Treatment of gastro-intestinal graft vs. host disease with rectal infusion of bacteria in patients not responsive to steroids.Steroid refractory gastro-intestinal acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantationEUCTR2017-002697-39-PLMaaT Pharma32
进行中（未招募）
1 期
Treatment of gastro-intestinal graft vs. host disease with rectal infusion of bacteria in patients not responsive to steroidsSteroid refractory gastro-intestinal acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantationMedDRA version: 20.1Level: PTClassification code 10066264Term: Acute graft versus host disease in intestineSystem Organ Class: 10021428 - Immune system disordersEUCTR2017-002697-39-ITMAAT PHARMA32
进行中（未招募）
1 期
Treatment of gastro-intestinal graft vs. host disease with rectal infusion of bacteria in patients not responsive to steroids.Steroid refractory gastro-intestinal acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantationEUCTR2017-002697-39-GBMaaT Pharma32
进行中（未招募）
1 期
Treatment of gastro-intestinal graft vs. host disease with rectal infusion of bacteria in patients not responsive to steroids.Steroid refractory gastro-intestinal acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantationEUCTR2017-002697-39-DEMaaT Pharma24
进行中（未招募）
1 期
Treatment of gastro-intestinal graft vs. host disease with rectal infusion of bacteria in patients not responsive to steroids.Steroid refractory gastro-intestinal acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantationEUCTR2017-002697-39-FRMaaT Pharma32