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NCT Number: NCT01632475

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Hyperplasia Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiratory Tract Diseases Thoracic Injuries Urogenital Diseases Ventilator-Induced Lung Injury Wounds and Injuries

Age range

4 month–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center, Seoul, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PNEUMOSTEM®

Biological

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.

Other names: Human umbilical cord blood-derived mesenchymal stem cells

Primary outcomes

  1. Number of subjects with Adverse Drug Reaction

    Time frame: at corrected age of 21 months (±3 months)

    Blood test, chest x-ray, physical exam

Secondary outcomes

  1. 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)

    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.

  2. Growth

    Time frame: Corrected gestational age of 4-6months, 8-12months, 18-24months

    Body weight, Head circumference, Height : growth percentile

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Medipost Co Ltd.

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2025
Study completion
2026
First posted
Jul 3, 2012
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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