Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia
NCT ID: NCT03873506
Last Updated: 2019-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2018-07-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mesenchymal Stem Cell
A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg)
transplantation of hUC-MSCs
Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.
Interventions
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transplantation of hUC-MSCs
Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject with a written consent form signed by a legal representative or a parent
Exclusion Criteria
2. subject who is considered inappropriate to participate the study by the investigator
1 Month
5 Years
ALL
No
Sponsors
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Children's Hospital of Chongqing Medical University
OTHER
Responsible Party
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Xia Yunqiu
Director
Principal Investigators
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Zhou Fu
Role: STUDY_CHAIR
Children's Hospital of Chongqing Medical University
Locations
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Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Lin Zou
Role: CONTACT
Facility Contacts
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Yunqiu Xia
Role: primary
References
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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.
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.
Other Identifiers
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yunqiu xia
Identifier Type: -
Identifier Source: org_study_id
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