Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)

Study Overview
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Brief Summary
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Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Detailed Description
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Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking. Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Official Title
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Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)

Conditions
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Bronchopulmonary Dysplasia

Intervention / Treatment
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* Drug: Human Umbilical Cord-derived Mesenchymal stem cell
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age Exclusion Criteria: Patients with severe congenital diseases Patients with IVH more than 3 grade Patients with severe sepsis Patients with active pulmonary hemorrhage

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 3 Weeks

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cell<br>Human Umbilical Cord-derived Mesenchymal stem cell in the saline | Drug: Human Umbilical Cord-derived Mesenchymal stem cell<br>* The Human Umbilical Cord-derived Mesenchymal stem cells suspension (2×10^7/kg per KG of the infant 's weight ) will be instilled once through a catheter into the infant' s endotracheal tube<br>|
| Placebo Comparator: placebo<br>saline without mesenchymal stem cell | Drug: placebo<br>* saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen requirement 3 days after transplantation | Temporal profiles of the fraction of inspiration oxygen 3 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in % | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen requirement 7 days after transplantation | Temporal profiles of the fraction of inspiration oxygen 7 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in % | 7 days | 
| Duration of ventilator dependence | The duration from transplantation to weaning from ventilator | up to 36 weeks PMA | 
| Incidence of severe BPD | percentage of participants with severe BPD ,diagnosed at 36 weeks PMA | up to 36 weeks PMA | 
| Survival rate | Percentage of participants who survived up to 36 weeks PMA | up to 36 weeks PMA | 
| Temperature | Temporal profiles of temperature | 3 days | 
| Heart rate | Temporal profiles of heart rate | 3 days | 
| Respiratory rate | Temporal profiles of respiratory rate | 3 days | 
| Duration of CPAP treatment | Duration of CPAP treatment | up to 36 weeks PMA | 
| Percentage of participants treated with steroids for weaning from ventilator | Percentage of participants treated with steroids for weaning from ventilator | up to 36 weeks PMA | 
| Growth velocity (Z-score) | percentile for body weight, height, and head circumference | up to 36 weeks PMA | 
| bronohoalveolar lavage (BAL) cytokine level | BAL were collected 7 days after transplantation for cytokine (IL-6，IL-8，TNF-α，TGF-β,VEGF,HGF) level examination, measured in pg/ml | 7 days | 
| The severity of BPD in X-ray patterns | A chest X-ray was performed in participants before and after transplantation. The severity of BPD (mild，moderate，severe) was assessed by a single radiographic doctor who is blind about randomization | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchopulmonary Dysplasia, Mesenchymal stem cell