Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia
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ClinicalTrials.gov Identifier: NCT03558334 |
Recruitment Status : Unknown
Verified May 2019 by Xia Yunqiu, Children's Hospital of Chongqing Medical University.
Recruitment status was: Recruiting
First Posted : June 15, 2018
Last Update Posted : May 21, 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 1 |
BPD is a chronic lung disease that occur in premature infants receiving prolonged oxygen pulmonary and ventilator therapy. It remains a main complication of extreme prematurity and currently lacks efficient treatment.The mortality rate of one year after birth is still high and the quality of life is not optimistic.
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 BPD.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
Allocation: | Non-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 Dysplasia in Premature Infants |
Actual Study Start Date : | June 28, 2018 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | June 30, 2022 |

Arm | Intervention/treatment |
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Experimental: Transplantation of Mesenchymal Stem Cell
Mesenchymal stem cell will be given to preterm infants with BPD.
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Drug: Transplantation of mesenchymal stem cell
Human umbilical cord-derived mesenchymal stem cell will be given to preterm infants through intravenous infusion. Dose A - 1 million cells per kg Dose B - 5 million cells per kg Other Name: Intravenous infusion of mesenchymal stem cell |
Active Comparator: No Transplantation of Mesenchymal Stem Cell
Mesenchymal stem cell will be not given to preterm infants with BPD.
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Drug: No transplantation of mesenchymal stem cell
Human umbilical cord-derived mesenchymal stem cell will be not given to preterm infants through intravenous infusion.
Other Name: No intravenous infusion of mesenchymal stem cell |
- Number of participants with adverse reactions related to infusion after treatment [ Time Frame: 24 hours after administration ]To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
- 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 BPD.
- Changes of temperature in participants [ Time Frame: 3 days after administration ]To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
- Changes of blood pressure in participants [ Time Frame: 3 days after administration ]To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. Blood pressure is measured by electronic sphygmomanometer .
- Changes of heart rate in participants [ Time Frame: 3 days after administration ]To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
- Changes of respiratory rate in participants [ Time Frame: 3 days after administration ]To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
- Changes of oxygen saturation in participants [ Time Frame: 3 days after administration ]To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
- Growth velocity (Z-score) in participants [ Time Frame: within 2 years after administration ]To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPD.

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Ages Eligible for Study: | 28 Days and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The participants meet the diagnostic criteria for moderate and severe BPD established by the National Institutes of Child Health and Human Development (NICHD) workshop.
- The participants have abnormal respiratory manifestations.
- Written consent form signed by a legal representative or a parent.
Exclusion Criteria:
- Although mechanical ventilation or oxygen is required in participants, there are no signs of dyspnea or BPD-related changes in lung imaging, such as central apnea or diaphragm paralysis.
- The participants who have complex congenital heart disease.
- The participants who have severe pulmonary hypertension(cardiac ultrasound confirmed) at the time of assessment.
- The participants who have severe respiratory tract malformation: pierre-robin syndrome, tracheobronchomalacia, vascular ring syndrome, congenital tracheal stenosis, tracheo-esophageal fistula, pulmonary emphysema, pulmonary sequestration, congenital pulmonary dysplasia, congenital pulmonary cyst, congenital spasm, etc.
- The participants who have severe chromosome anomalies :Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc).
- The participants who have severe congenital infection(Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc).
- The participants who have severe sepsis or shock.
- The participants who is going to have surgery 72 hours before/after this study drug administration.
- The participants who have surfactant administration within 24 hours before this study drug administration.
- The participants who have severe intracranial hemorrhage ≥ grade 3 or 4.
- The participants who have active pulmonary hemorrhage or active air leak syndrome at the time of assessment.
- The participants who have the history of other clinical studies as a participant.
- The participants who is considered inappropriate by the investigators.

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): NCT03558334
Contact: Yunqiu Xia | 13637719980 | sunny_199001@foxmail.com | |
Contact: Lin Zou | 18623121280 |
China, Chongqing | |
Children's Hospital of Chongqing Medical University | Recruiting |
Chongqing, Chongqing, China, 400014 | |
Contact: Yunqiu Xia 13637719980 sunny_199001@foxmail.com |
Study Chair: | Zhou Fu | Children's Hospital of Chongqing Medical University |
Responsible Party: | Xia Yunqiu, doctor, Children's Hospital of Chongqing Medical University |
ClinicalTrials.gov Identifier: | NCT03558334 |
Other Study ID Numbers: |
XYunqiu |
First Posted: | June 15, 2018 Key Record Dates |
Last Update Posted: | May 21, 2019 |
Last Verified: | May 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 |
Bronchopulmonary Dysplasia human umbilical cord -derived mesenchymal stem cells |
Bronchopulmonary Dysplasia Hyperplasia Pathologic Processes Ventilator-Induced Lung Injury Lung Injury |
Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases |