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Efficacy of Bone Marrow Mesenchymal Stem Cell in Pulmonary Hemosiderosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02985346
Recruitment Status : Not yet recruiting
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Information provided by (Responsible Party):
Weiping Tan, Sun Yat-sen University

Brief Summary:
Pulmonary hemosiderosis (PH) is a pulmonary hemosiderin deposition which caused by alveolar capillary hemorrhage. PH is easy to recurrent and can lead to pulmonary fibrosis and insufficiency if the disease was poor controlled. Steroid is the most common drug that was administered in acute phase of the disease. However, considered the side-effects, steroid is not suitable for long-time maintenance. Therefore, it is necessary to explore a new therapy. Bone marrow mesenchymal stem cells (BMSC) are a kind of adult stem cells with high self-renewal and multi-directional differentiation potential in bone marrow. It has become a hot topic in immunosuppressive and tissue repair therapy in recent years. To date, homing, colonization and differentiation of BMSCs in the lung have been observed in animal models of pulmonary hypertension, radiation pneumonitis and pulmonary fibrosis. It had been reported that BMSC transplantation in acute lung injury in mice, inflammation of lung injury can significantly improve. The aim of this study is to explore the effect of BMSC on PH and its mechanism, and to explore a new way to promote the repair of IPH. It is expected to improve the status of IPH therapy in children, especially improve the prognosis of refractory PH.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Hemosiderosis Biological: Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sun Yat-sen Memorial Hospital
Study Start Date : January 2017
Estimated Primary Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BMSC group
Patients received Bone marrow mesenchymal stem cells (BMSC) plus standard treatment
Biological: Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis
Active Comparator: Control group
Patients received standard treatment
Biological: Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis

Primary Outcome Measures :
  1. Complete remission [ Time Frame: 3-6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients diagnosed with Pulmonary hemosiderosis at an age less than 18 years.

Exclusion Criteria:

  • Patients who cannot finish the established causes or die during the causes.
Publications of Results:

Other Publications:
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Responsible Party: Weiping Tan, Sun Yat-sen Memorial Hospital, Sun Yat-sen University Identifier: NCT02985346    
Other Study ID Numbers: WTan
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Keywords provided by Weiping Tan, Sun Yat-sen University:
Idiopathic pulmonary hemosiderosis
Bone marrow mesenchymal stem cells
Additional relevant MeSH terms:
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Lung Diseases
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Respiratory Tract Diseases