Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia
This trial is active, not recruiting.
|Conditions||bronchopulmonary dysplasia, extremely premature infants, severe bpd that conventional therapies has failed, no severe congenital anomalies, no severe ivh neither cystic pvl|
|Treatments||ucmscs, normal saline|
|Sponsor||China Medical University Hospital|
|Start date||July 2010|
|End date||June 2012|
|Trial size||10 participants|
|Trial identifier||NCT01207869, DMR99-104|
Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely premature infant with severe BPD to establish whether intratracheal instillation of umbilical cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe BPD.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (caregiver, investigator)|
The relations between the cytokine concentrations in the BAL fluid and PAP.
time frame: Up to 20 weeks
The severity score of BPD ranging from 0 to 6 on the serial chest radiographs
time frame: 6 months to 1 year
Male or female participants up to 6 months old.
Inclusion Criteria: - severe BPD, defined by the National Institute of Child Health and Human Development workshop, who conventional therapies (including furosemide and theophylline, and HFO ventilation) has failed Exclusion Criteria: - severe congenital anomalies - severe intraventricular hemorrhage ≥ grade 3 or cystic periventricular leukomalacia.
|Official title||Intratracheal Instillation of Umbilical Cord-derived Mesenchymal Stem Cells as a Rescue Treatment for Severe Bronchopulmonary Dysplasia|
|Principal investigator||Bai-Horng Su, MD, PhD|
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