NCT01632475

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Sep 2011Sep 2026

Study Start

First participant enrolled

September 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 3, 2012

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

14 years

First QC Date

June 27, 2012

Last Update Submit

April 7, 2019

Conditions

Bronchopulmonary Dysplasia

Keywords

Human umbilical cord blood-derived mesenchymal stem cellsPremature infantsBronchopulmonary dysplasiaLung injuryLung diseasesHyperplasiaVentilator-induced lung injuryRespiratory lung diseasesPathologic ProcessesInfant, Premature, DiseasesInfant, Newborn, Diseases

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with Adverse Drug Reaction

    Blood test, chest x-ray, physical exam

    at corrected age of 21 months (±3 months)

Secondary Outcomes (2)

  • 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)

  • Growth

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

Study Arms (1)

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

Biological: Pneumostem®

Interventions

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.

Also known as: Human umbilical cord blood-derived mesenchymal stem cells
Pneumostem®

Eligibility Criteria

Age4 Months - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants who enrolled in the study of phase 1 clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia. (NCT01297205)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Ahn SY, Chang YS, Kim JH, Sung SI, Park WS. Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia. J Pediatr. 2017 Jun;185:49-54.e2. doi: 10.1016/j.jpeds.2017.02.061. Epub 2017 Mar 21.

    PMID: 28341525DERIVED

Related Links

MeSH Terms

Conditions

Bronchopulmonary DysplasiaPremature BirthLung InjuryLung DiseasesHyperplasiaVentilator-Induced Lung InjuryPathologic ProcessesInfant, Premature, DiseasesInfant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesThoracic InjuriesWounds and InjuriesPathological Conditions, Signs and Symptoms

Study Officials

  • Won-Soon Park, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

June 27, 2012

First Posted

July 3, 2012

Study Start

September 1, 2011

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

KR(2)