Back to resultsHuman Mesenchymal Stem Cells For Bronchopulmonary Dysplasia
Primary Purpose
Bronchopulmonary Dysplasia
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Transplantation of mesenchymal stem cell
No transplantation of mesenchymal stem cell
Sponsored by
About this trial
This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring Bronchopulmonary Dysplasia, human umbilical cord -derived mesenchymal stem cells
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital of Chongqing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transplantation of Mesenchymal Stem Cell
No Transplantation of Mesenchymal Stem Cell
Arm Description
Mesenchymal stem cell will be given to preterm infants with BPD.
Mesenchymal stem cell will be not given to preterm infants with BPD.
Outcomes
Primary Outcome Measures
Number of participants with adverse reactions related to infusion after treatment
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Secondary Outcome Measures
Changes of high-resolution chest CT in participants
To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPD.
Changes of temperature in participants
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Changes of blood pressure in participants
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
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Changes of respiratory rate in participants
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Changes of oxygen saturation in participants
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Growth velocity (Z-score) in participants
To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPD.
Full Information
NCT ID
NCT03558334
First Posted
June 4, 2018
Last Updated
May 19, 2019
Sponsor
Children's Hospital of Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03558334
Brief Title
Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia
Official Title
Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Chongqing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 premature infants for moderate and severe Bronchopulmonary Dysplasia（BPD）.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Bronchopulmonary Dysplasia, human umbilical cord -derived mesenchymal stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transplantation of Mesenchymal Stem Cell
Arm Type
Experimental
Arm Description
Mesenchymal stem cell will be given to preterm infants with BPD.
Arm Title
No Transplantation of Mesenchymal Stem Cell
Arm Type
Active Comparator
Arm Description
Mesenchymal stem cell will be not given to preterm infants with BPD.
Intervention Type
Drug
Intervention Name(s)
Transplantation of mesenchymal stem cell
Other Intervention Name(s)
Intravenous infusion of mesenchymal stem cell
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
No transplantation of mesenchymal stem cell
Other Intervention Name(s)
No intravenous infusion of mesenchymal stem cell
Intervention Description
Human umbilical cord-derived mesenchymal stem cell will be not given to preterm infants through intravenous infusion.
Primary Outcome Measure Information:
Title
Number of participants with adverse reactions related to infusion after treatment
Description
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Time Frame
24 hours after administration
Secondary Outcome Measure Information:
Title
Changes of high-resolution chest CT in participants
Description
To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPD.
Time Frame
within 2 years after administration
Title
Changes of temperature in participants
Description
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Time Frame
3 days after administration
Title
Changes of blood pressure in participants
Description
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. Blood pressure is measured by electronic sphygmomanometer .
Time Frame
3 days after administration
Title
Changes of heart rate in participants
Description
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Time Frame
3 days after administration
Title
Changes of respiratory rate in participants
Description
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Time Frame
3 days after administration
Title
Changes of oxygen saturation in participants
Description
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Time Frame
3 days after administration
Title
Growth velocity (Z-score) in participants
Description
To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPD.
Time Frame
within 2 years after administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunqiu Xia
Phone
13637719980
Email
sunny_199001@foxmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Zou
Phone
18623121280
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhou Fu
Organizational Affiliation
Children's Hospital of Chongqing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunqiu Xia
Phone
13637719980
Email
sunny_199001@foxmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24508444
Citation
Chang YS, Ahn SY, Yoo HS, Sung SI, Choi SJ, Oh WI, Park WS. Mesenchymal stem cells for bronchopulmonary dysplasia: phase 1 dose-escalation clinical trial. J Pediatr. 2014 May;164(5):966-972.e6. doi: 10.1016/j.jpeds.2013.12.011. Epub 2014 Feb 6.
Results Reference
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PubMed Identifier
21336467
Citation
Hayes D Jr, Meadows JT Jr, Murphy BS, Feola DJ, Shook LA, Ballard HO. Pulmonary function outcomes in bronchopulmonary dysplasia through childhood and into adulthood: implications for primary care. Prim Care Respir J. 2011 Jun;20(2):128-33. doi: 10.4104/pcrj.2011.00002.
Results Reference
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PubMed Identifier
28341525
Citation
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.
Results Reference
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PubMed Identifier
25529339
Citation
Wilson JG, Liu KD, Zhuo H, Caballero L, McMillan M, Fang X, Cosgrove K, Vojnik R, Calfee CS, Lee JW, Rogers AJ, Levitt J, Wiener-Kronish J, Bajwa EK, Leavitt A, McKenna D, Thompson BT, Matthay MA. Mesenchymal stem (stromal) cells for treatment of ARDS: a phase 1 clinical trial. Lancet Respir Med. 2015 Jan;3(1):24-32. doi: 10.1016/S2213-2600(14)70291-7. Epub 2014 Dec 17.
Results Reference
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PubMed Identifier
26928452
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.
Results Reference
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PubMed Identifier
23212278
Citation
Pierro M, Ionescu L, Montemurro T, Vadivel A, Weissmann G, Oudit G, Emery D, Bodiga S, Eaton F, Peault B, Mosca F, Lazzari L, Thebaud B. Short-term, long-term and paracrine effect of human umbilical cord-derived stem cells in lung injury prevention and repair in experimental bronchopulmonary dysplasia. Thorax. 2013 May;68(5):475-84. doi: 10.1136/thoraxjnl-2012-202323. Epub 2012 Dec 4.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia
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