Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

Phase 2

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Drug: Transplantation of mesenchymal stem cell; Drug: No Transplantation of Mesenchymal Stem Cell

• Registration Number: NCT03601416
• Lead Sponsor: Children's Hospital of Chongqing Medical University

Brief Summary

This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in children with moderate and severe bronchopulmonary dysplasia.

Detailed Description

Bronchopulmonary dysplasia (BPD) is one of the most common chronic lung diseases with poor prognosis, especially in preterm infants with moderate and severe BPD. However, there is lack of effective therapies for this disease.

hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get.Many animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal models of lung disease.Furthermore,there are a large number of clinical trials of MSCs applied to various system diseases and the safety was verified.So,the main purpose of this study is to evaluate the safety and efficacy of hUC-MSCs in participants with moderate and severe bronchopulmonary dysplasia.

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-15
• Study Start: 2019-07-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

1. Participants with moderate and severe bronchopulmonary dysplasia are not well treated by routine therapy
2. The legal representative or the participant had signed consent.

Exclusion Criteria

• 1. Severe underlying diseases (e.g. systemic and hematological malignancies, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, III-IV grade pulmonary hypertension, Lung transplantation, current indications of acute surgery after lung transplantation) 2. Participants whose age is more than 1 year old.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transplantation of Mesenchymal Stem Cell	Transplantation of mesenchymal stem cell	Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.
No Transplantation of Mesenchymal Stem Cell	No Transplantation of Mesenchymal Stem Cell	Mesenchymal stem cell will be not given to participants with moderate and severe bronchopulmonary dysplasia.

Primary Outcome Measures

Name	Time	Method
the accumulative duration of oxygen therapy	from the time of diagnosis to the time of stopping oxygen therapy	To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.

Secondary Outcome Measures

Name	Time	Method
Changes of blood pressure in participants	24 hours after administration	To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. Blood pressure is measured by electronic sphygmomanometer .
Changes of heart rate in participants	24 hours after administration	To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.

Trial Locations

Locations (1)

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China