NCT02023788

Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Medipost Co Ltd. · Industry
• Sex: All
• Age: 45 Months – 63 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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®.

Conditions

• Bronchopulmonary Dysplasia
• Respiratory Tract Infections
• Premature Birth of Newborn

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): 2.0 x 10\^7 cells/kg \* The subjects were administered with Pneumostem in the earlier part of the Phase I study. No drug/biologics will be administered to any subject during this part of the study.

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-12-30
• Last updated: 2018-09-04

Locations

1 site across 1 country: South Korea