Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia

Study Overview
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Brief Summary
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Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely premature infant with severe BPD to establish whether intratracheal instillation of umbilical cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe BPD.

Official Title
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Intratracheal Instillation of Umbilical Cord-derived Mesenchymal Stem Cells as a Rescue Treatment for Severe Bronchopulmonary Dysplasia

Conditions
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Bronchopulmonary Dysplasia, Extremely Premature Infants, Severe BPD That Conventional Therapies Has Failed, No Severe Congenital Anomalies, no Severe IVH Neither Cystic PVL

Intervention / Treatment
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* Biological: ucMSCs
* Other: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe BPD, defined by the National Institute of Child Health and Human Development workshop, who conventional therapies (including furosemide and theophylline, and HFO ventilation) has failed Exclusion Criteria: severe congenital anomalies severe intraventricular hemorrhage ≥ grade 3 or cystic periventricular leukomalacia.

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 6 Months

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cells<br>the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube | Biological: ucMSCs<br>* the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube<br>|
| Placebo Comparator: Control<br>Normal saline | Other: Normal saline<br>* the same amount of ucMSCs suspension will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relations between the cytokine concentrations in the BAL fluid and PAP. | To examine the relations between the cytokine concentrations in the BAL fluid and PAP. | Up to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity score of BPD ranging from 0 to 6 on the serial chest radiographs | The severity score of BPD ranging from 0 to 6 on the serial chest radiographs will be graded by a single radiologist, without knowledge of the infant's identity or clinical course, using the roentgenographic severity scoring system. | 6 months to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchopulmonary dysplasia (BPD), Extremely premature infant, Mesenchymal stem cells (MSCs), umbilical cord