Efficacy of Bone Marrow Mesenchymal Stem Cell in Pulmonary Hemosiderosis

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02985346
Collaborator
(none)
100
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Complete remission [3-6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 18 Years
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Weiping Tan, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02985346
Other Study ID Numbers:
  • WTan
First Posted:
Dec 7, 2016
Last Update Posted:
Dec 7, 2016
Last Verified:
Dec 1, 2016
Keywords provided by Weiping Tan, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2016