To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
mesenchymal stem cells treatement of BPD for safety and effect evaluation0.9% sodium chloride incontrol group
0.9% sodium chloride in control group
number of patients with BPD after instillation mesenchymal stem cells
incidence of BPD
Time frame: up to 28 days after birth
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