Efficacy of Bone Marrow Mesenchymal Stem Cell in Pulmonary Hemosiderosis
Primary Purpose
Idiopathic Pulmonary Hemosiderosis
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Hemosiderosis focused on measuring Idiopathic pulmonary hemosiderosis, Bone marrow mesenchymal stem cells
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BMSC group
Control group
Arm Description
Patients received Bone marrow mesenchymal stem cells (BMSC) plus standard treatment
Patients received standard treatment
Outcomes
Primary Outcome Measures
Complete remission
Secondary Outcome Measures
Full Information
NCT ID
NCT02985346
First Posted
December 3, 2016
Last Updated
December 6, 2016
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02985346
Brief Title
Efficacy of Bone Marrow Mesenchymal Stem Cell in Pulmonary Hemosiderosis
Official Title
Sun Yat-sen Memorial Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Hemosiderosis
Keywords
Idiopathic pulmonary hemosiderosis, Bone marrow mesenchymal stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BMSC group
Arm Type
Experimental
Arm Description
Patients received Bone marrow mesenchymal stem cells (BMSC) plus standard treatment
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients received standard treatment
Intervention Type
Biological
Intervention Name(s)
Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis
Primary Outcome Measure Information:
Title
Complete remission
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
4800237
Citation
Byrd RB, Gracey DR. Immunosuppressive treatment of idiopathic pulmonary hemosiderosis. JAMA. 1973 Oct 22;226(4):458-9. No abstract available.
Results Reference
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PubMed Identifier
11665500
Citation
Airaghi L, Ciceri L, Giannini S, Ferrero S, Meroni PL, Tedeschi A. Idiopathic pulmonary hemosiderosis in an adult. Favourable response to azathioprine. Monaldi Arch Chest Dis. 2001 Jun;56(3):211-3.
Results Reference
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PubMed Identifier
12490803
Citation
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Results Reference
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PubMed Identifier
17609633
Citation
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Results Reference
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PubMed Identifier
15891110
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
21128750
Citation
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Results Reference
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PubMed Identifier
21585237
Citation
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Citation
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Results Reference
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Efficacy of Bone Marrow Mesenchymal Stem Cell in Pulmonary Hemosiderosis
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