Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
This trial is active, not recruiting.
|Sponsor||Samsung Medical Center|
|Collaborator||Medipost Co Ltd.|
|Start date||September 2011|
|End date||September 2017|
|Trial size||9 participants|
|Trial identifier||NCT01632475, MP-CR-006-F/U|
This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
Number of subjects with Adverse Drug Reaction
time frame: at corrected age of 21 months (±3 months)
Neurological development test outcome from the subjects who were treated with Pneumostem®, compared with the patients who suffered from the same conditions but not treated with Pneumostem®
time frame: at corrected age of 10 months (±2 months) and 21 months (±3 months)
time frame: Corrected gestational age of 4-6months, 8-12months, 18-24months
Male or female participants from 4 months up to 2 years old.
Inclusion Criteria: - all Infants who enrolled in the Phase 1 PNEUMOSTEM® clinical trial (NCT01297205) Exclusion Criteria: - Infants whose parent or legal guardian did not want to participate in the study
|Official title||Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia|
|Principal investigator||Won-Soon Park, MD, PhD|
|Description||Bronchopulmonary dysplasia (BPD) is the most common cause of death for premature newborns with low birth weights. In addition, many children who recover from the disease suffer from various complications such as prolonged hospitalization, pulmonary hypertension, and failure to thrive. 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.|
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