Brief Title
Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia
Official Title
Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children
Brief Summary
This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in children with moderate and severe bronchopulmonary dysplasia.
Detailed Description
Bronchopulmonary dysplasia (BPD) is one of the most common chronic lung diseases with poor prognosis, especially in preterm infants with moderate and severe BPD. However, there is lack of effective therapies for this disease. hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get.Many animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal models of lung disease.Furthermore,there are a large number of clinical trials of MSCs applied to various system diseases and the safety was verified.So,the main purpose of this study is to evaluate the safety and efficacy of hUC-MSCs in participants with moderate and severe bronchopulmonary dysplasia.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
the accumulative duration of oxygen therapy
Secondary Outcome
Changes of blood pressure in participants
Condition
Bronchopulmonary Dysplasia
Intervention
Transplantation of mesenchymal stem cell
Study Arms / Comparison Groups
Transplantation of Mesenchymal Stem Cell
Description: Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
57
Start Date
July 1, 2019
Completion Date
December 31, 2021
Primary Completion Date
June 1, 2021
Eligibility Criteria
Inclusion Criteria: 1. Participants with moderate and severe bronchopulmonary dysplasia are not well treated by routine therapy 2. The legal representative or the participant had signed consent. Exclusion Criteria: - 1. Severe underlying diseases (e.g. systemic and hematological malignancies, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, III-IV grade pulmonary hypertension, Lung transplantation, current indications of acute surgery after lung transplantation) 2. Participants whose age is more than 1 year old.
Gender
All
Ages
N/A - 1 Year
Accepts Healthy Volunteers
No
Contacts
Zhou Fu, 023-63622066, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03601416
Organization ID
Xia Yunqiu
Responsible Party
Principal Investigator
Study Sponsor
Children's Hospital of Chongqing Medical University
Study Sponsor
Zhou Fu, Study Chair, Children's Hospital of Chongqing Medical University
Verification Date
January 2019