Status:
UNKNOWN
Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia
Lead Sponsor:
Children's Hospital of Chongqing Medical University
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
4-14 years
Phase:
PHASE1
PHASE2
Brief 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 ris...
Detailed 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 eff...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03774537
Start Date
March 1 2019
End Date
December 31 2021
Last Update
March 6 2019
Active Locations (1)
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1
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China