NCT01297205

Brief Summary

PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended to treat premature infants with bronchopulmonary dysplasia. This study is to assess the safety and the efficacy of this study drug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

9 months

First QC Date

February 11, 2011

Last Update Submit

April 3, 2014

Conditions

Bronchopulmonary Dysplasia

Keywords

Human Umbilical Cord Blood Derived Mesenchymal Stem CellsBronchopulmonary dysplasiaPremature infants

Outcome Measures

Primary Outcomes (1)

  • Number of participant with adverse reaction

    Number of paitents with normal rage of vital signs and laboratory examination Chest x-ray result, Duration of ventilator dependence, Duration of CPAP treatment, Duration of intubation, Occurrence of pneumothorax, Occurrence of intraventricular hemorrhage, Postnatal steroid use (%), Dose of surfactant (%) Cumulative duration of oxygen use

    12 weeks from the day of treatment

Secondary Outcomes (1)

  • Incidence of BPD at 36 Week's postmenstrual age

    36 week's postmenstrual age

Study Arms (1)

PNEUMOSTEM®

EXPERIMENTAL
Biological: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells

Interventions

Human Umbilical Cord Blood Derived-Mesenchymal Stem CellsBIOLOGICAL

Dose A - 10 million cells per kg Dose B - 20 million cells per kg Single intratracheal administration

Also known as: PNEUMOSTEM®
PNEUMOSTEM®

Eligibility Criteria

Age5 Days - 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight range: 500g\~1250g
  • Fetal gestational age: 23 weeks to 29 weeks
  • Premature infants who cannot do spontaneous breathing, which ventilation rate is less than 12 breaths per min of ventilation rate and 25% of oxygen demand
  • Premature infants who does not improve the breathing or worse within 24 hours prior to enrollment of this study
  • Written consent form signed by a legal representative or a parent

You may not qualify if:

  • Cyanotic or acyanotic congenital heart diseases except patent ductus arteriosus
  • Severe lung malformation (i.e. Pulmonary hypoplasia, congenital diaphragmatic hernia, congenital cystic lung disease)
  • Severe lung malformation with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
  • Severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
  • CRP \> 30 mg/dL; Severe sepsis or shock
  • Premature infants who is going to or expected to have surgery 72 hours before/after this study drug administration
  • Surfactant administration within 24 hours prior to this study drug administration
  • Severe intracranial hemorrhage ≥ grade 3 or 4
  • Premature infants who have active pulmonary hemorrhage or active air leak syndrome at the time point of screening
  • History of other clinical studies as a participant
  • Premature infants who are allergic to Gentamicin
  • Premature infants who is considered inappropriate by the investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Chang YS, Ahn SY, Yoo HS, Sung SI, Choi SJ, Oh WI, Park WS. Mesenchymal stem cells for bronchopulmonary dysplasia: phase 1 dose-escalation clinical trial. J Pediatr. 2014 May;164(5):966-972.e6. doi: 10.1016/j.jpeds.2013.12.011. Epub 2014 Feb 6.

    PMID: 24508444DERIVED

MeSH Terms

Conditions

Bronchopulmonary DysplasiaPremature Birth

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

Study Officials

  • Won-Soon Park, M.D., PhD.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 16, 2011

Study Start

December 1, 2010

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

April 7, 2014

Record last verified: 2014-04

Locations

KR(1)