search
Back to results

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
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

1 Month - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 3, 2016
    Last Updated
    December 6, 2016
    Sponsor
    Sun Yat-sen University
    search

    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
    background
    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
    background
    PubMed Identifier
    12490803
    Citation
    Calabrese F, Giacometti C, Rea F, Loy M, Sartori F, Di Vittorio G, Abudureheman A, Thiene G, Valente M. Recurrence of idiopathic pulmonary hemosiderosis in a young adult patient after bilateral single-lung transplantation. Transplantation. 2002 Dec 15;74(11):1643-5. doi: 10.1097/00007890-200212150-00027.
    Results Reference
    background
    PubMed Identifier
    17609633
    Citation
    Chen RL, Chuang SS. Silent idiopathic pulmonary hemosiderosis with iron-deficiency anemia but normal serum ferritin. J Pediatr Hematol Oncol. 2007 Jul;29(7):509-11. doi: 10.1097/MPH.0b013e3180950372. No abstract available.
    Results Reference
    background
    PubMed Identifier
    15891110
    Citation
    Rojas M, Xu J, Woods CR, Mora AL, Spears W, Roman J, Brigham KL. Bone marrow-derived mesenchymal stem cells in repair of the injured lung. Am J Respir Cell Mol Biol. 2005 Aug;33(2):145-52. doi: 10.1165/rcmb.2004-0330OC. Epub 2005 May 12.
    Results Reference
    result
    PubMed Identifier
    15615854
    Citation
    Wang G, Bunnell BA, Painter RG, Quiniones BC, Tom S, Lanson NA Jr, Spees JL, Bertucci D, Peister A, Weiss DJ, Valentine VG, Prockop DJ, Kolls JK. Adult stem cells from bone marrow stroma differentiate into airway epithelial cells: potential therapy for cystic fibrosis. Proc Natl Acad Sci U S A. 2005 Jan 4;102(1):186-91. doi: 10.1073/pnas.0406266102. Epub 2004 Dec 22.
    Results Reference
    result
    PubMed Identifier
    19721001
    Citation
    Lee JW, Fang X, Gupta N, Serikov V, Matthay MA. Allogeneic human mesenchymal stem cells for treatment of E. coli endotoxin-induced acute lung injury in the ex vivo perfused human lung. Proc Natl Acad Sci U S A. 2009 Sep 22;106(38):16357-62. doi: 10.1073/pnas.0907996106. Epub 2009 Aug 31.
    Results Reference
    result
    PubMed Identifier
    21128750
    Citation
    Knight DA, Rossi FM, Hackett TL. Mesenchymal stem cells for repair of the airway epithelium in asthma. Expert Rev Respir Med. 2010 Dec;4(6):747-58. doi: 10.1586/ers.10.72.
    Results Reference
    result
    PubMed Identifier
    21585237
    Citation
    Hoffman AM, Paxson JA, Mazan MR, Davis AM, Tyagi S, Murthy S, Ingenito EP. Lung-derived mesenchymal stromal cell post-transplantation survival, persistence, paracrine expression, and repair of elastase-injured lung. Stem Cells Dev. 2011 Oct;20(10):1779-92. doi: 10.1089/scd.2011.0105. Epub 2011 Jul 6.
    Results Reference
    result
    PubMed Identifier
    23154940
    Citation
    Liu AR, Liu L, Chen S, Yang Y, Zhao HJ, Liu L, Guo FM, Lu XM, Qiu HB. Activation of canonical wnt pathway promotes differentiation of mouse bone marrow-derived MSCs into type II alveolar epithelial cells, confers resistance to oxidative stress, and promotes their migration to injured lung tissue in vitro. J Cell Physiol. 2013 Jun;228(6):1270-83. doi: 10.1002/jcp.24282.
    Results Reference
    result

    Learn more about this trial

    Efficacy of Bone Marrow Mesenchymal Stem Cell in Pulmonary Hemosiderosis

    We'll reach out to this number within 24 hrs