Overview

This trial is active, not recruiting.

Condition bronchopulmonary dysplasia
Treatment pneumostem®
Phase phase 1
Sponsor Samsung Medical Center
Collaborator Medipost Co Ltd.
Start date September 2011
End date September 2017
Trial size 9 participants
Trial identifier NCT01632475, MP-CR-006-F/U

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Low Dose Group (3 subjects): 1.0 x 10^7 cells/kg, High Dose Group (6 subjects): 2.0 x 10^7 cells/kg
pneumostem® Human umbilical cord blood-derived mesenchymal stem cells
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.

Primary Outcomes

Measure
Number of subjects with Adverse Drug Reaction
time frame: at corrected age of 21 months (±3 months)

Secondary Outcomes

Measure
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®
time frame: at corrected age of 10 months (±2 months) and 21 months (±3 months)
Growth
time frame: Corrected gestational age of 4-6months, 8-12months, 18-24months

Eligibility Criteria

Male or female participants from 4 months up to 2 years old.

Inclusion Criteria: - all Infants who enrolled in the Phase 1 PNEUMOSTEM® clinical trial (NCT01297205) Exclusion Criteria: - Infants whose parent or legal guardian did not want to participate in the study

Additional Information

Official title Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Principal investigator Won-Soon Park, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Samsung Medical Center.