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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03683953

Enrollment

200

Registered

2018-09-25

Start date

2018-09-29

Completion date

2020-07-01

Last updated

2018-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Drugs, Safety Issues

Keywords

mesenchymal stem cells, safety, effect, BPD

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

Interventions

OTHERmesenchymal stem cells therapy

mesenchymal stem cells treatement of BPD for safety and effect evaluation0.9% sodium chloride incontrol group

DRUG0.9% sodium chloride

0.9% sodium chloride in control group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

28 Weeks to 37 Weeks

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

Design outcomes

Primary

Measure	Time frame	Description
number of patients with BPD after instillation mesenchymal stem cells	up to 28 days after birth	incidence of BPD

Contacts

Primary ContactZhuxiao Ren, MD

renzhx1990@163.com+8613538984634

Backup ContactJie Yang, PHD

jieyang0830@163.com39151777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026