Brief Title
Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia
Official Title
Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Premature Infants At High Risk For Bronchopulmonary
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 risk for Bronchopulmonary Dysplasia(BPD)
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 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 Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of participants with adverse reactions related to infusion after treatment
Secondary Outcome
The incidence and severity of BPD defined by the National Institutes of Child Health and Human Development (NICHD) workshop.
Condition
Bronchopulmonary Dysplasia
Intervention
Transplantation of hUC-MSCs
Study Arms / Comparison Groups
Transplantation of hUC-MSCs
Description: Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
March 1, 2019
Completion Date
December 31, 2021
Primary Completion Date
December 1, 2020
Eligibility Criteria
Inclusion Criteria: 1. An infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth) 2. Gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) < 28 weeks) 3. Birth weight is between 500g and 1000g, inclusive 4. 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 5. Written consent form signed by a legal representative or a parent. Exclusion Criteria: 1. 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. 2. The participants who have complex congenital heart disease. 3. The participants who have severe pulmonary hypertension(cardiac ultrasound confirmed) at the time of assessment. 4. 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. 5. The participants who have severe chromosome anomalies :Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc). 6. The participants who have severe congenital infection(Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc). 7. The participants who have severe sepsis or shock. 8. The participants who is going to have surgery 72 hours before/after this study drug administration. 9. The participants who have surfactant administration within 24 hours before this study drug administration. 10. The participants who have severe intracranial hemorrhage ≥ grade 3 or 4. 11. The participants who have active pulmonary hemorrhage or active air leak syndrome at the time of assessment. 12. The participants who have the history of other clinical studies as a participant. 13. The participants who is considered inappropriate by the investigators.
Gender
All
Ages
N/A - 14 Days
Accepts Healthy Volunteers
No
Contacts
Zhou Fu, 13637719980, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03774537
Organization ID
XiaYQ
Responsible Party
Principal Investigator
Study Sponsor
Children's Hospital of Chongqing Medical University
Study Sponsor
Zhou Fu, Study Chair, Children's Hospital of Chongqing Medical University
Verification Date
March 2019