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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03601416
Other study ID # Xia Yunqiu
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2019
Est. completion date December 31, 2021

Study information

Verified date January 2019
Source Children's Hospital of Chongqing Medical University
Contact Yunqiu Xia
Phone 023-63622066
Email sunny_199001@foxmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 57
Est. completion date December 31, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility 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


Related Conditions & MeSH terms


Intervention

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
No Transplantation of Mesenchymal Stem Cell
Human umbilical cord-derived mesenchymal stem cell will be not given to participants through intravenous infusion.

Locations

Country Name City State
China Children's Hospital of Chongqing Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Ahn SY, Chang YS, Kim JH, Sung SI, Park WS. Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia. J Pediatr. 2017 Jun;185:49-54.e2. doi: 10.1016/j.jpeds.2017.02.061. Epub 2017 Mar 21. — View Citation

Hansmann G, Fernandez-Gonzalez A, Aslam M, Vitali SH, Martin T, Mitsialis SA, Kourembanas S. Mesenchymal stem cell-mediated reversal of bronchopulmonary dysplasia and associated pulmonary hypertension. Pulm Circ. 2012 Apr-Jun;2(2):170-81. doi: 10.4103/2045-8932.97603. — View Citation

Laube M, Stolzing A, Thome UH, Fabian C. Therapeutic potential of mesenchymal stem cells for pulmonary complications associated with preterm birth. Int J Biochem Cell Biol. 2016 May;74:18-32. doi: 10.1016/j.biocel.2016.02.023. Epub 2016 Feb 27. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Changes of respiratory rate in participants To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. 24 hours after administration
Other Changes of high-resolution chest CT in participants To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. within 2 years after administration
Primary the accumulative duration of oxygen therapy To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. from the time of diagnosis to the time of stopping oxygen therapy
Secondary Changes of blood pressure in participants 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 . 24 hours after administration
Secondary Changes of heart rate in participants To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. 24 hours after administration
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