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

Guangdong Women and Children Hospital

Status and phase: Unknown; Phase 1

Conditions: Effect of Drugs; Safety Issues

Treatments: Other: mesenchymal stem cells therapy; Drug: 0.9% sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03683953

Guangdong W CH

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 28 to 37 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

0.9% sodium chloride intratracheal instillate on 14 days after birth

Treatment:

Drug: 0.9% sodium chloride

mesenchymal stem cells

Experimental group

Description:

mesenchymal stem cells intratracheal instillate on 14 days after birth ,dose is 25 million cells/kg

Treatment:

Other: mesenchymal stem cells therapy