Efficacy of Bone Marrow Mesenchymal Stem Cell in Pulmonary Hemosiderosis

Sun Yat-sen University

Status and phase: Unknown; Early Phase 1

Conditions: Idiopathic Pulmonary Hemosiderosis

Treatments: Biological: Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis

Study type: Interventional

Funder types: Other

Identifiers

NCT02985346

WTan

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

BMSC group

Experimental group

Description:

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

Treatment:

Biological: Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis

Control group

Active Comparator group

Description:

Patients received standard treatment

Treatment:

Biological: Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis