Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02274428

Enrollment

Registered

2014-10-24

Start date

2014-10-31

Completion date

2016-12-31

Last updated

2017-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesenchymal Stromal Cells

Keywords

intraventricular hemorrhage

Brief summary

Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical cord blood derived mesenchymal stem cells) in the premature infants with intraventricular hemorrhage (IVH, grade 3-4)

Interventions

DRUGpneumostem

human umbilical cord blood derived mesenchymal stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

23 Weeks to 34 Weeks

Healthy volunteers

Inclusion criteria

* 23-34w * IVH grade 3-4, confirmed with brain ultrasonogram * within 7 days after IVH diagnosis

Exclusion criteria

* severe congenital anomaly * intrauterine intracranial bleeding * intracranial infection * severe congenital infection * active and uncontrolled infection, CRP\>10mg/dl * Platelet count \<50,000/ml * severe metabolic acidosis (PH\<7.1, BE\<-20)

Design outcomes

Primary

Measure	Time frame
unsuspected death or anaphylactic shock	within 6 h after pneumostem transplantation

Secondary

Measure	Time frame	Description
Death or hydrocephalus required shunt operation	First discharge home, maximum time frame : 1 year	outcome measurement time frame would not exceed 1 year after birth

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026