NCT01897987

Brief Summary

This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT01828957) will be followed-up until 60 months of corrected age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 4, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

6.2 years

First QC Date

July 4, 2013

Last Update Submit

August 5, 2020

Conditions

Bronchopulmonary Dysplasia

Keywords

Human Umbilical Cord Blood Derived Mesenchymal Stem CellsBronchopulmonary dysplasiaPremature infants

Outcome Measures

Primary Outcomes (1)

  • Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection

    6, 12, 18, 24, 36, 48, and 60 months, corrected age

Secondary Outcomes (9)

  • Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator)

    6, 12, 18, 24, 36, 48, and 60 months, corrected age

  • Number of admissions to Emergency Room

    6, 12, 18, 24, 36, 48, and 60 months, corrected age

  • Survival

    6, 12, 18, 24, 36, 48, and 60 months, corrected age

  • Growth measured by Z-score

    6, 12, 18, 24, 36, 48, and 60 months, corrected age

  • Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy

    24 months, corrected age

  • +4 more secondary outcomes

Study Arms (2)

Pneumostem®

EXPERIMENTAL

A single intratracheal administration of Pneumostem® (1.0 x 10\^7 cells/kg)

Biological: Pneumostem®

normal saline

PLACEBO COMPARATOR

A single intratracheal administration of normal saline

Biological: normal saline

Interventions

Pneumostem®BIOLOGICAL
Also known as: Human umbilical cord blood-derived mesenchymal stem cells
Pneumostem®
normal salineBIOLOGICAL
normal saline

Eligibility Criteria

Age7 Months - 7 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subject who completed the safety and efficacy evaluations in Pneumostem Phase II clinical trial
  • Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

You may not qualify if:

  • Subject whose parent or legal representative does not agree to participate in the study
  • subject who is considered inappropriate to participate in the study by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Ahn SY, Chang YS, Lee MH, Sung S, Kim AR, Park WS. Five-year follow-up of phase II trial of stromal cells for bronchopulmonary dysplasia. Thorax. 2023 Nov;78(11):1105-1110. doi: 10.1136/thorax-2022-219622. Epub 2023 Aug 21.

    PMID: 37604693DERIVED

MeSH Terms

Conditions

Bronchopulmonary DysplasiaPremature Birth

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Wonsoon Park, MD, PhD

    Department of Pediatrics, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Ai-Rhan Kim, MD, PhD

    Department of Neonatology, Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2013

First Posted

July 12, 2013

Study Start

January 1, 2014

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

August 7, 2020

Record last verified: 2020-08

Locations

KR(2)