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.
Study Type
OBSERVATIONAL
Enrollment
9
A single intratracheal administration Low Dose Group (3 patients): 1.0 x 10\^7 cells/kg, High Dose Group (6 patients): 2 x 10\^7 cells/kg \* The subjects were administered with Pneumostem® in the earlier part of the phase I study. No drugs/biologics are administered during this part of the study.
Samsung Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Number of subjects with Adverse Drug Reaction
Blood test, chest x-ray, physical exam
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®
Bayely test results of the 9 subjects who were treated with Pneumostem® during the early part of the Phase I study. The results of Brain MRI study performed at corrected age of 18-24 months.
Time frame: at corrected age of 10 months (±2 months) and 21 months (±3 months)
Growth
Body weight, Head circumference, Height : growth percentile
Time frame: Corrected gestational age of 4-6months, 8-12months, 18-24months
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