Brief Title
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia
Official Title
Intratracheal Instillation of Umbilical Cord-derived Mesenchymal Stem Cells as a Rescue Treatment for Severe Bronchopulmonary Dysplasia
Brief Summary
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
The relations between the cytokine concentrations in the BAL fluid and PAP.
Secondary Outcome
The severity score of BPD ranging from 0 to 6 on the serial chest radiographs
Condition
Bronchopulmonary Dysplasia
Intervention
ucMSCs
Study Arms / Comparison Groups
Mesenchymal stem cells
Description: the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
10
Start Date
July 2010
Completion Date
July 2012
Primary Completion Date
June 2012
Eligibility Criteria
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.
Gender
All
Ages
N/A - 6 Months
Accepts Healthy Volunteers
No
Contacts
Bai-Horng Su, MD, PhD, ,
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT01207869
Organization ID
DMR99-104
Study Sponsor
China Medical University Hospital
Study Sponsor
Bai-Horng Su, MD, PhD, Principal Investigator, China Medical University Hospital,Taiwan
Verification Date
September 2010