Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

Chongqing Medical University

Status and phase: Unknown; Phase 2

Conditions: Bronchopulmonary Dysplasia

Treatments: Drug: Transplantation of mesenchymal stem cell; Drug: No Transplantation of Mesenchymal Stem Cell

Study type: Interventional

Funder types: Other

Identifiers

NCT03601416

Xia Yunqiu

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 estimated patients

Sex: All

Ages: 28 days to 1 year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Transplantation of Mesenchymal Stem Cell

Experimental group

Description:

Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.

Treatment:

Drug: Transplantation of mesenchymal stem cell

No Transplantation of Mesenchymal Stem Cell

Active Comparator group

Description:

Mesenchymal stem cell will be not given to participants with moderate and severe bronchopulmonary dysplasia.

Treatment:

Drug: No Transplantation of Mesenchymal Stem Cell