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

Samsung Medical Center9 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mesenchymal Stromal Cells

Interventions

pneumostemDRUG

human umbilical cord blood derived mesenchymal stem cells

Eligibility

Sex: ALLMin age: 23 WeeksMax age: 34 Weeks

Medical Language ↔ Plain English

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)

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

unsuspected death or anaphylactic shock

Time frame: within 6 h after pneumostem transplantation

Secondary Outcomes

Death or hydrocephalus required shunt operation

outcome measurement time frame would not exceed 1 year after birth

Time frame: First discharge home, maximum time frame : 1 year

Data from ClinicalTrials.gov

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