Bronchopulmonary Dysplasia
Conditions
Keywords
human umbilical cord -derived mesenchymal stem cells, moderate and severe bronchopulmonary dysplasia
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.
Interventions
Human umbilical cord-derived mesenchymal stem cell will be given to participants through intravenous infusion. Dose A - 1 million cells per kg Dose B - 5 million cells per kg
Human umbilical cord-derived mesenchymal stem cell will be not given to participants through intravenous infusion.
Sponsors
Children's Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Days to 1 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes of respiratory 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. |
| Changes of high-resolution chest CT in participants | within 2 years after administration | To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. |
Countries
China
Contacts
Primary ContactYunqiu Xia
Backup ContactLin Zou
Outcome results
None listed