NL-OMON48907招募中2 期
An explorative study for halting inflammation in patients with emphysema by administration of allogeneic bone marrow derived mesenchymal stromal cells. - HEP study
ongziekten0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Signed informed consent consistent with ICH-GCP guidelines and local
- •legislation prior to participation in the trial.
- •2.Males or females between 45 and 65 years of age;
- •3.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.
- •4. Pre bronchodilator value measured FEV1 between 20% and 45% predicted; TLCO
- •between 30% and 45% pred.; RV/TLC > 0.5.
- •5. Patients in a stable clinical condition.
排除标准
- •1. Significant cardiac failure;
- •2. active smoking, or < 6 months smoking cessation;
- •3. or failure to complete pulmonary rehab program before randomization;
- •4. women of child bearing potential;
- •5. any cancer treated in the previous 5 years;
- •6. women of child-bearing potential not using adequate contraception;
- •7. any other condition of the patient that the clinical investigator deemed
- •harmful for study participation.
研究者
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