Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children

Conditions
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Bronchopulmonary Dysplasia

Intervention / Treatment
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* Drug: Transplantation of mesenchymal stem cell
* Drug: No Transplantation of Mesenchymal Stem Cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with moderate and severe bronchopulmonary dysplasia are not well treated by routine therapy 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.

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transplantation of Mesenchymal Stem Cell<br>Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia. | Drug: Transplantation of mesenchymal stem cell<br>* Human umbilical cord-derived mesenchymal stem cell will be given to participants through intravenous infusion. Dose A - 1 million cells per kg Dose B - 5 million cells per kg<br>|
| Active Comparator: No Transplantation of Mesenchymal Stem Cell<br>Mesenchymal stem cell will be not given to participants with moderate and severe bronchopulmonary dysplasia. | Drug: No Transplantation of Mesenchymal Stem Cell<br>* Human umbilical cord-derived mesenchymal stem cell will be not given to participants through intravenous infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the accumulative duration of oxygen therapy | To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. | from the time of diagnosis to the time of stopping oxygen therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of blood pressure in participants | To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. Blood pressure is measured by electronic sphygmomanometer . | 24 hours after administration | 
| Changes of heart rate in participants | To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. | 24 hours after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moderate and severe bronchopulmonary dysplasia, human umbilical cord -derived mesenchymal stem cells