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

Active, not recruiting

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Biological: Pneumostem®

• Registration Number: NCT01632475
• Lead Sponsor: Samsung Medical Center

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-07-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-07
• Last Update Posted: 2019-04-09
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• all Infants who enrolled in the Phase 1 PNEUMOSTEM® clinical trial (NCT01297205)

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Exclusion Criteria

• Infants whose parent or legal guardian did not want to participate in the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pneumostem®	Pneumostem®	Low Dose Group (3 subjects): 1.0 x 10\^7 cells/kg, High Dose Group (6 subjects): 2.0 x 10\^7 cells/kg

Primary Outcome Measures

Name	Time	Method
Number of subjects with Adverse Drug Reaction	at corrected age of 21 months (±3 months)	Blood test, chest x-ray, physical exam

Secondary Outcome Measures

Name	Time	Method
Growth	Corrected gestational age of 4-6months, 8-12months, 18-24months	Body weight, Head circumference, Height : growth percentile
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®	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of