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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-29

Study Completion Date

2020-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema

NCT01872624

Pulmonary Emphysema

COMPLETED NA

Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

NCT02257463

Chronic Obstructive Pulmonary Disease

COMPLETED NA

The Impact of Diaphragmatic Breathing Instructions and Inspiratory Pressures on Diaphragm Contraction in Healthy Adults

NCT06347549

Diaphragm

COMPLETED

Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019

NCT04371601

COVID-19 Pneumonia

UNKNOWN EARLY_PHASE1

Ventilatory Muscle Training by Breath-Stacking in Healthy Youngsters

NCT03258944

Muscle Weakness

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Safety Issues Effect of Drugs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

0.9% sodium chloride intratracheal instillate on 14 days after birth

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride

Intervention Type DRUG

0.9% sodium chloride in control group

mesenchymal stem cells

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

Group Type EXPERIMENTAL

mesenchymal stem cells therapy

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mesenchymal stem cells therapy

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

Intervention Type OTHER

0.9% sodium chloride

0.9% sodium chloride in control group

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No