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Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis
资助者: Assiut University
合作者:
监督者:

预计研究完成时间: 2018-12-01
预计完成时间: 2018-10-01

详细标题

  • Mesenchymal Stem Cell as Therapeutic Modality in Interstitial Pulmonary Fibrosis

简略摘要

  • Currently, the application status of MSCs as treatment modalities in IPF is still in its infancy and remains exploratory. Although a number of safety and efficacy clinical trials of MSCs as therapeutic options in immune-mediated and cardiac diseases have already been published with tantalizing results, to our disappointment, pulmonary and critical care medicine have traditionally lagged behind other therapeutic and research fields including hematology, gastroenterology and cardiology in translational studies of the use of reparative cells

详细摘要


研究层级

  • Interventional

研究阶段

  • Phase 1

研究设计

  • Intervention Model: Single Group Assignment
    Masking: None (Open Label)
    Primary Purpose: Treatment

研究条件

  • Stem Cell Transplant Complications

研究干预

  • Biological: autologous bone marrow mesenchymal stem cells intravenous infusion

研究手段

  • Experimental: IPF patients autologous bone marrow mesenchymal stem cells Intervention: Biological: autologous bone marrow mesenchymal stem cells

出版物


研究状态

  • Not yet recruiting

招聘人数

  • 12

招聘准则

  • Inclusion Criteria: Age 18 to 75 years (both inclusive) high-resolution computed tomography (HRCT) scan that is very suggestive or consistent with a probable diagnosis of usual interstitial pneumonia. Bronchoalveolar lavage must be performed at any time before inclusion and must have failed to show features supporting alternative diagnoses. The duration of the disease should be more than three months, and bibasilar inspiratory crackles should be present. dyspnea score of at least 2 on a scale of 0 (minimum) to 10 (maximum). FVC > 50% of the predicted normal value and DLco > 35% of the predicted value. Patients under treatment with n-acetylcysteine or pirfenidone should discontinue drug and enter a wash-out period for at least 6 weeks prior study enrolment. Exclusion Criteria: FVC < 50% predicted normal value and DLCO < 35%predicted normal value. lung cancer or with an evidence of active malignancyfor at least 5 years. uncontrolled heart failure. renal failure hepatic failure, neurological abnormalities including stroke and myasthenia Gravis Anti-coagulants therapy. Active infections.

性别

  • Sexes Eligible for Study: All

年龄

  • 18 Years to 65 Years   (Adult, Older Adult)

志愿者

  • No

联系人


国别


NCT编号

  • NCT03187431