NCT03683953

The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Guangdong Women and Children Hospital · Academic / Other
• Sex: All
• Age: 28 Weeks – 37 Weeks
• Healthy volunteers: Not accepted

Summary

To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD

Detailed description

This is a Phase 1 clinical trial that constitues two points cohorts with 100 participants per cohort who will receive instillation dose of mesenchymal stem cells-25 million cells/kg,with ventilation after 14 days.And the placebol will be 0.9% sodium choride. The investigator will proceed the groups during the same period. 1. Deographic Data and Baseline charateristics of the studied groups were collected: Gestational age (weeks) Birth weight (g) gender Cesarean section delivery Antenatal steroids Prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes 2. mesenchymal stem cels dose is 25 million cells/kg 3. Assessment the incidence of BPD after instillation of Mesenchymal stem cells 4. the adverse after instillation of Mesenchymal stem cells

Conditions

• Safety Issues
• Effect of Drugs

Interventions

Type	Name	Description
OTHER	mesenchymal stem cells therapy	mesenchymal stem cells treatement of BPD for safety and effect evaluation0.9% sodium chloride incontrol group
DRUG	0.9% sodium chloride	0.9% sodium chloride in control group

Timeline

• Start date: 2018-09-29
• Primary completion: 2019-08-01
• Completion: 2020-07-01
• First posted: 2018-09-25
• Last updated: 2018-09-25