Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    20
  • sponsor
    Children's Hospital of Chongqing Medical University
Updated on 23 January 2021

Summary

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 DysplasiaBPD

Description

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

Details
Condition Bronchopulmonary Dysplasia, bronchopulmonary dysplasia (bpd)
Treatment transplantation of hUC-MSCs, No transplantation of hUC-MSCs
Clinical Study IdentifierNCT03774537
SponsorChildren's Hospital of Chongqing Medical University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

An infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth)
Gestational age is between 23 and 28 weeks (23 weeks gestational age (GA) < 28 weeks)
Birth weight is between 500g and 1000g, inclusive
Being intubated and receiving mechanical ventilation within 5-14 days after birth, with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening
Written consent form signed by a legal representative or a parent

Exclusion Criteria

Although mechanical ventilation or oxygen is required in participants, there are no signs of dyspnea or BPD-related changes in lung imaging, such as central apnea or diaphragm paralysis
The participants who have complex congenital heart disease
The participants who have severe pulmonary hypertension(cardiac ultrasound confirmed) at the time of assessment
The participants who have severe respiratory tract malformation: pierre-robin syndrome, tracheobronchomalacia, vascular ring syndrome, congenital tracheal stenosis, tracheo-esophageal fistula, pulmonary emphysema, pulmonary sequestration, congenital pulmonary dysplasia, congenital pulmonary cyst, congenital spasm, etc
The participants who have severe chromosome anomalies :Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
The participants who have severe congenital infection(Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
The participants who have severe sepsis or shock
The participants who is going to have surgery 72 hours before/after this study drug administration
The participants who have surfactant administration within 24 hours before this study drug administration
The participants who have severe intracranial hemorrhage grade 3 or 4
The participants who have active pulmonary hemorrhage or active air leak syndrome at the time of assessment
The participants who have the history of other clinical studies as a participant
The participants who is considered inappropriate by the investigators
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