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 at high risk for 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 at high risk for BPD
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs through intravenous infusion. Dose A - 1 million cells per kg; Dose B - 5 million cells per kg
Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs
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 hUC-MSCs for BPD.
Time frame: 24 hours after administration
The incidence and severity of BPD defined by the National Institutes of Child Health and Human Development (NICHD) workshop.
To evaluate the efficacy of hUC-MSCs to prevent preterm infants at high risk of BPD from developing BPD
Time frame: at the corrected gestational age of 36 weeks
Changes of high-resolution chest CT in participants
To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPDmesenchymal 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.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 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.
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Time frame: 3 days after administration