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
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