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

Phase 1

• Conditions: Effect of Drugs; Safety Issues
• Interventions: Other: mesenchymal stem cells therapy; Drug: 0.9% sodium chloride

• Registration Number: NCT03683953
• Lead Sponsor: Guangdong Women and Children Hospital

Brief 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

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Last Update Submitted: 2018-09-24
• Study First Posted: 2018-09-25
• Last Update Posted: 2018-09-25
• Study Start: 2018-09-29
• Primary Completion: 2019-08-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

twenty-eight weeks to thirty-seven weeks prematures who need ventilaton for 14 days after birth, and the oxygen concentration is more than 30%

Exclusion Criteria

Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mesenchymal stem cells	mesenchymal stem cells therapy	mesenchymal stem cells intratracheal instillate on 14 days after birth ,dose is 25 million cells/kg
Placebo	0.9% sodium chloride	0.9% sodium chloride intratracheal instillate on 14 days after birth

Primary Outcome Measures

Name	Time	Method
number of patients with BPD after instillation mesenchymal stem cells	up to 28 days after birth	incidence of BPD