跳至主要内容
临床试验/EUCTR2017-001853-15-NL
EUCTR2017-001853-15-NL进行中(未招募)1 期

An explorative study for halting inflammation in patients with emphysema by intravenous administration of autologous bone marrow derived mesenchymal stromal cells. - HEP study

eiden University Medical Center0 个研究点目标入组 30 人开始时间: 2018年4月30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
30

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

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • -Age lower than 65;
  • -emphysema as reported by a radiologist present in CT images of the lung;
  • -gradient of emphysema severity towards the lung apex as assessed by CT-derived lung densitometry by Pulmo CMS software (Medis, NL) and equally distributed between left and right lung;
  • -FEV1 between 25% and 45% pred ;
  • -TLCO between 30% and 45% pred.;
  • -patients in a stable clinical condition.
  • 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 30
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • -Significant cardiac failure; or active smoking, or
  • -< 6 months smoking cessation;
  • -or failure to complete pulmonary rehab program before randomization;
  • -or women of child bearing potential;
  • -or any other condition of the patient that the clinical investigator deemed harmful for study participation.

研究者

发起方
eiden University Medical Center

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