Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia
Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children
1 other identifier
interventional
57
1 country
1
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 children with moderate and severe bronchopulmonary dysplasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJanuary 15, 2019
January 1, 2019
1.9 years
July 17, 2018
January 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Changes of blood pressure in participants
24 hours after administration
Changes of heart rate in participants
24 hours after administration
Other Outcomes (2)
Changes of respiratory rate in participants
24 hours after administration
Changes of high-resolution chest CT in participants
within 2 years after administration
Study Arms (2)
Transplantation of Mesenchymal Stem Cell
EXPERIMENTALMesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.
No Transplantation of Mesenchymal Stem Cell
ACTIVE COMPARATORMesenchymal stem cell will be not given to participants with moderate and severe bronchopulmonary dysplasia.
Interventions
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
Human umbilical cord-derived mesenchymal stem cell will be not given to participants through intravenous infusion.
Eligibility Criteria
You may qualify if:
- Participants with moderate and severe bronchopulmonary dysplasia are not well treated by routine therapy
- The legal representative or the participant had signed consent.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014, China
Related Publications (4)
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.
PMID: 28341525BACKGROUNDLaube 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.
PMID: 26928452BACKGROUNDHansmann 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.
PMID: 22837858BACKGROUNDWu X, Xia Y, Zhou O, Song Y, Zhang X, Tian D, Li Q, Shu C, Liu E, Yuan X, He L, Liu C, Li J, Liang X, Yang K, Fu Z, Zou L, Bao L, Dai J. Allogeneic human umbilical cord-derived mesenchymal stem cells for severe bronchopulmonary dysplasia in children: study protocol for a randomized controlled trial (MSC-BPD trial). Trials. 2020 Jan 31;21(1):125. doi: 10.1186/s13063-019-3935-x.
PMID: 32005282DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhou Fu
Children's Hospital of Chongqing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
July 17, 2018
First Posted
July 26, 2018
Study Start
July 1, 2019
Primary Completion
June 1, 2021
Study Completion
December 31, 2021
Last Updated
January 15, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share