Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Locations
- 3
- Primary Endpoint
- Oxygen requirement 3 days after transplantation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Weeks to 3 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients with severe congenital diseases
- •Patients with IVH more than 3 grade
- •Patients with severe sepsis
- •Patients with active pulmonary hemorrhage
Arms & Interventions
Mesenchymal stem cell
Human Umbilical Cord-derived Mesenchymal stem cell in the saline
Intervention: Human Umbilical Cord-derived Mesenchymal stem cell (Drug)
placebo
saline without mesenchymal stem cell
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Oxygen requirement 3 days after transplantation
Time Frame: 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 Outcomes
- Oxygen requirement 7 days after transplantation(7 days)
- Duration of ventilator dependence(up to 36 weeks PMA)
- Incidence of severe BPD(up to 36 weeks PMA)
- Survival rate(up to 36 weeks PMA)
- Temperature(3 days)
- Heart rate(3 days)
- Respiratory rate(3 days)
- Duration of CPAP treatment(up to 36 weeks PMA)
- Percentage of participants treated with steroids for weaning from ventilator(up to 36 weeks PMA)
- Growth velocity (Z-score)(up to 36 weeks PMA)
- bronohoalveolar lavage (BAL) cytokine level(7 days)
- The severity of BPD in X-ray patterns(7 days)