Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03601416
• Other study ID #: Xia Yunqiu
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

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