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Efficacy of Bone Marrow Mesenchymal Stem Cell in Pulmonary Hemosiderosis

NCT ID: NCT02985346

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Pulmonary Hemosiderosis

Keywords

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Idiopathic pulmonary hemosiderosis Bone marrow mesenchymal stem cells

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMSC group

Patients received Bone marrow mesenchymal stem cells (BMSC) plus standard treatment

Group Type EXPERIMENTAL

Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis

Intervention Type BIOLOGICAL

Control group

Patients received standard treatment

Group Type ACTIVE_COMPARATOR

Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis

Intervention Type BIOLOGICAL

Interventions

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Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Weiping Tan

Sun Yat-sen Memorial Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Byrd RB, Gracey DR. Immunosuppressive treatment of idiopathic pulmonary hemosiderosis. JAMA. 1973 Oct 22;226(4):458-9. No abstract available.

Reference Type BACKGROUND
PMID: 4800237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11665500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12490803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17609633 (View on PubMed)

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.

Reference Type RESULT
PMID: 15891110 (View on PubMed)

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.

Reference Type RESULT
PMID: 15615854 (View on PubMed)

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.

Reference Type RESULT
PMID: 19721001 (View on PubMed)

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.

Reference Type RESULT
PMID: 21128750 (View on PubMed)

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.

Reference Type RESULT
PMID: 21585237 (View on PubMed)

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.

Reference Type RESULT
PMID: 23154940 (View on PubMed)

Other Identifiers

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WTan

Identifier Type: -

Identifier Source: org_study_id