Bronchopulmonary Dysplasia Clinical Trial
Official title:
Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
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.
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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