Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
- Conditions
- Bronchopulmonary Dysplasia
- Interventions
- Drug: Human Umbilical Cord-derived Mesenchymal stem cellDrug: placebo
- Registration Number
- NCT03645525
- Lead Sponsor
- Children's Hospital of Fudan University
- Brief Summary
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.
- Detailed Description
Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking.
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age
- Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age
- Patients with severe congenital diseases
- Patients with IVH more than 3 grade
- Patients with severe sepsis
- Patients with active pulmonary hemorrhage
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mesenchymal stem cell Human Umbilical Cord-derived Mesenchymal stem cell Human Umbilical Cord-derived Mesenchymal stem cell in the saline placebo placebo saline without mesenchymal stem cell
- Primary Outcome Measures
Name Time Method Oxygen requirement 3 days after transplantation 3 days Temporal profiles of the fraction of inspiration oxygen 3 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %
- Secondary Outcome Measures
Name Time Method Oxygen requirement 7 days after transplantation 7 days Temporal profiles of the fraction of inspiration oxygen 7 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %
Duration of ventilator dependence up to 36 weeks PMA The duration from transplantation to weaning from ventilator
Incidence of severe BPD up to 36 weeks PMA percentage of participants with severe BPD ,diagnosed at 36 weeks PMA
Survival rate up to 36 weeks PMA Percentage of participants who survived up to 36 weeks PMA
Temperature 3 days Temporal profiles of temperature
Heart rate 3 days Temporal profiles of heart rate
Respiratory rate 3 days Temporal profiles of respiratory rate
Duration of CPAP treatment up to 36 weeks PMA Duration of CPAP treatment
Percentage of participants treated with steroids for weaning from ventilator up to 36 weeks PMA Percentage of participants treated with steroids for weaning from ventilator
Growth velocity (Z-score) up to 36 weeks PMA percentile for body weight, height, and head circumference
bronohoalveolar lavage (BAL) cytokine level 7 days BAL were collected 7 days after transplantation for cytokine (IL-6，IL-8，TNF-α，TGF-β,VEGF,HGF) level examination, measured in pg/ml
The severity of BPD in X-ray patterns 7 days A chest X-ray was performed in participants before and after transplantation. The severity of BPD (mild，moderate，severe) was assessed by a single radiographic doctor who is blind about randomization
Trial Locations
- Locations (3)
Obstetrics and Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Children's Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai First Maternity and Infant Hospital
🇨🇳Shanghai, Shanghai, China