NCT01632475

Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia

Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 4 Months – 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
BIOLOGICAL	Pneumostem®	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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2025-09-01
• Completion: 2026-09-01
• First posted: 2012-07-03
• Last updated: 2019-04-09

Locations

2 sites across 1 country: South Korea