Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
NCT ID: NCT01632475
Last Updated: 2019-04-09
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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ACTIVE_NOT_RECRUITING
9 participants
OBSERVATIONAL
2011-09-30
2026-09-30
Brief Summary
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Detailed Description
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It has been reported that bone marrow-derived mesenchymal stem cells (BM-MSC) can differentiate into pulmonary epithelial and pulmonary endothelial cells. Some animal studies showed that BM-MSCs differentiate into bronchial cells and type 2 pneumocytes in rats with pneumonia and improve the fibrosis that occur after administration of bleomycin. Based on the findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged lung as well as BPD that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes, and so on.
PNEUMOSTEM® consists of human umbilical cord blood-derived mesenchymal stem cells and is intended to treat BPD in premature infants. This is a long term follow-up study of the earlier part of the phase I clinical trial.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Pneumostem®
Low Dose Group (3 subjects): 1.0 x 10\^7 cells/kg, High Dose Group (6 subjects): 2.0 x 10\^7 cells/kg
Pneumostem®
A single intratracheal administration
Low Dose Group (3 patients): 1.0 x 10\^7 cells/kg, High Dose Group (6 patients): 2 x 10\^7 cells/kg
\* The subjects were administered with Pneumostem® in the earlier part of the phase I study. No drugs/biologics are administered during this part of the study.
Interventions
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Pneumostem®
A single intratracheal administration
Low Dose Group (3 patients): 1.0 x 10\^7 cells/kg, High Dose Group (6 patients): 2 x 10\^7 cells/kg
\* The subjects were administered with Pneumostem® in the earlier part of the phase I study. No drugs/biologics are administered during this part of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Months
2 Years
ALL
No
Sponsors
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Medipost Co Ltd.
INDUSTRY
Samsung Medical Center
OTHER
Responsible Party
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Won Soon Park
Professor of Pediatrics
Principal Investigators
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Won-Soon Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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References
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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.
Related Links
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Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia
Other Identifiers
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MP-CR-006-F/U
Identifier Type: -
Identifier Source: org_study_id
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