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 premature infants for moderate and severe Bronchopulmonary Dysplasia(BPD).
BPD is a chronic lung disease that occur in premature infants receiving prolonged oxygen pulmonary and ventilator therapy. It remains a main complication of extreme prematurity and currently lacks efficient treatment.The mortality rate of one year after birth is still high and the quality of life is not optimistic. 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 BPD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Human umbilical cord-derived mesenchymal stem cell will be given to preterm infants through intravenous infusion. Dose A - 1 million cells per kg Dose B - 5 million cells per kg
Human umbilical cord-derived mesenchymal stem cell will be not given to preterm infants through intravenous infusion.
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGNumber of participants with adverse reactions related to infusion after treatment
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Time frame: 24 hours after administration
Changes of high-resolution chest CT in participants
To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPD.
Time frame: within 2 years after administration
Changes of temperature in participants
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Time frame: 3 days after administration
Changes of blood pressure in participants
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. Blood pressure is measured by electronic sphygmomanometer .
Time frame: 3 days after administration
Changes of heart rate in participants
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Time frame: 3 days after administration
Changes of respiratory rate in participants
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Time frame: 3 days after administration
Changes of oxygen saturation in participants
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Time frame: 3 days after administration
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Growth velocity (Z-score) in participants
To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPD.
Time frame: within 2 years after administration