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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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
saline
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China
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 %
Time frame: 3 days
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 %
Time frame: 7 days
Duration of ventilator dependence
The duration from transplantation to weaning from ventilator
Time frame: up to 36 weeks PMA
Incidence of severe BPD
percentage of participants with severe BPD ,diagnosed at 36 weeks PMA
Time frame: up to 36 weeks PMA
Survival rate
Percentage of participants who survived up to 36 weeks PMA
Time frame: up to 36 weeks PMA
Temperature
Temporal profiles of temperature
Time frame: 3 days
Heart rate
Temporal profiles of heart rate
Time frame: 3 days
Respiratory rate
Temporal profiles of respiratory rate
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Time frame: 3 days
Duration of CPAP treatment
Duration of CPAP treatment
Time frame: 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
Time frame: up to 36 weeks PMA
Growth velocity (Z-score)
percentile for body weight, height, and head circumference
Time frame: 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
Time frame: 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
Time frame: 7 days