Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia
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ClinicalTrials.gov Identifier: NCT03601416 |
Recruitment Status : Unknown
Verified January 2019 by Xia Yunqiu, Children's Hospital of Chongqing Medical University.
Recruitment status was: Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : January 15, 2019
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Condition or disease | Intervention/treatment | Phase |
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Bronchopulmonary Dysplasia | Drug: Transplantation of mesenchymal stem cell Drug: No Transplantation of Mesenchymal Stem Cell | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 57 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children |
Estimated Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | June 1, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
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Experimental: Transplantation of Mesenchymal Stem Cell
Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.
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Drug: Transplantation of mesenchymal stem cell
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 |
Active Comparator: No Transplantation of Mesenchymal Stem Cell
Mesenchymal stem cell will be not given to participants with moderate and severe bronchopulmonary dysplasia.
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Drug: No Transplantation of Mesenchymal Stem Cell
Human umbilical cord-derived mesenchymal stem cell will be not given to participants through intravenous infusion. |
- the accumulative duration of oxygen therapy [ Time Frame: 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.
- Changes of blood pressure in participants [ Time Frame: 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 [ Time Frame: 24 hours after administration ]To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.
- Changes of respiratory rate in participants [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 28 Days to 1 Year (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants with moderate and severe bronchopulmonary dysplasia are not well treated by routine therapy
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601416
Contact: Yunqiu Xia | 023-63622066 | sunny_199001@foxmail.com | |
Contact: Lin Zou | 023-63622066 |
China, Chongqing | |
Children's Hospital of Chongqing Medical University | |
Chongqing, Chongqing, China, 400014 | |
Contact: Yunqiu Xia 13637719980 sunny_199001@foxmail.com |
Study Chair: | Zhou Fu | Children's Hospital of Chongqing Medical University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Xia Yunqiu, doctor, Children's Hospital of Chongqing Medical University |
ClinicalTrials.gov Identifier: | NCT03601416 |
Other Study ID Numbers: |
Xia Yunqiu |
First Posted: | July 26, 2018 Key Record Dates |
Last Update Posted: | January 15, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
human umbilical cord -derived mesenchymal stem cells moderate and severe bronchopulmonary dysplasia |
Bronchopulmonary Dysplasia Hyperplasia Pathologic Processes Ventilator-Induced Lung Injury Lung Injury |
Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases |