This trial is active, not recruiting.

Conditions bronchopulmonary dysplasia, respiratory tract infections, premature birth of newborn
Treatment pneumostem
Sponsor Medipost Co Ltd.
Start date April 2014
End date July 2016
Trial size 9 participants
Trial identifier NCT02023788, MP-CR-006-F/U-5y


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Low Dose Group (3 subjects): 1.0 x 10^7 cells/kg, High Dose Group (6 subjects): 2.0 x 10^7 cells/kg Intervention: Biological: Pneumostem®
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): 2.0 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.

Primary Outcomes

Number of subjects with adverse drug reactions
time frame: 60 months (corrected age)

Secondary Outcomes

Respiratory outcomes
time frame: 60 months (corrected age)
time frame: 60 months (corrected age)
time frame: 60 months (corrected age)
Potential neurological development test outcomes
time frame: 60 months (corrected age)

Eligibility Criteria

Male or female participants from 45 months up to 63 months old.

Inclusion Criteria

  • All infants who were enrolled in the 2-year follow-up study (NCT01632475) of phase 1 clinical trial for the safety and efficacy evaluations of PNEUMOSTEM® treatment in premature infants with bronchopulmonary dysplasia
  • Infants with a written consent form signed by a parent or legal guardian

Exclusion Criteria

    Additional Information

    Official title Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
    Principal investigator Won-Soon Park, MD, PhD
    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®.
    Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
    Information provided to ClinicalTrials.gov by Medipost Co Ltd..