Bronchopulmonary Dysplasia Clinical Trial
Official title:
Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.
Bronchopulmonary dysplasia (BPD) is the most common cause of death for prematurely born
babies with low birth weights. In addition, many children who recover from this 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. The purpose of the study is to evaluate 3-5 year
long term safety and efficacy in patients who completed the earlier part of the phase I
clinical trial of PNEUMOSTEM®.
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