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临床试验/NCT01977131
NCT01977131已完成1 期

Phase 1 Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis

Wei Yu0 个研究点目标入组 10 人开始时间: 2010年6月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
10
主要终点
Absence of lung deficits during the procedure and/or in the 6 months follow-up

研究概览

简要总结

The aim of this study was to analyze the safety, pulmonary function, and imaging changes of patients with silicosis treated with autologous bone marrow stromal cells with modification by hepatocyte growth factor.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18-50, chronic and accelerated silicosis, characterized with a fibrotic increase in the last two years, FEV1 <60% and > 40%, FVC > 60% and SaO2 >90%

排除标准

  • smoking, active tuberculosis or other infections, cancer, auto-immune disorders, hematological, hepatic or cardiac diseases, and pregnancy

结局指标

主要结局

Absence of lung deficits during the procedure and/or in the 6 months follow-up

时间窗: 6 months

次要结局

  • Improvement of pulmonary deficits(1 year)

研究者

发起方
Wei Yu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wei Yu

Doctor

Guangzhou Municipal Twelfth People's Hospital

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