Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)

Phase 2Active Not RecruitingNCT02890953

Samsung Medical Center22 enrolled

Overview

The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cell Transplantation

Interventions

PneumostemDRUG

direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap

Normal salineDRUG

direct intracerebroventricular injection of normal saline via ventricular tap

Eligibility

Sex: ALLMax age: 28 Days

Medical Language ↔ Plain English

Inclusion Criteria: * IVH grade 3-4 * age : within postnatal day 28 * gestational age: 23-\<34 weeks Exclusion Criteria: * Patient with severe congenital abnormalities * Patient with antenatal brain hemorrhage * Patient with asphyxia or Hypoxic ischemic encepalophathy * Patient with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc) * Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc) * Patient withCRP \> 30 mg/dL; Severe sepsis or shock * Patient with a history of participating in other clinical studies * Patient who is considered inappropriate to participate in the study by the investigator

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Shunt or death

Shunt operation or death

Time frame: 40 weeks of corrected age

Secondary Outcomes

Death

Time frame: at 2years

Developmental delay in gross motor function, 2y

Cerebral palsy, gross motor function classification system score ≥2

Time frame: at 2years

Developmental delay Bayley -3

Bayley-3 scores \<70

Time frame: at 2years

Developmental delay in KDST, 2y

Korean Developmental Screening Test scores, below two standard deviations was classified as delayed

Time frame: at 2 years

Language delay

Korean Sequenced Language Scale for Infant score

Time frame: at 2 years, at 5 years

Developmental delay in KDST, 5y

Korean Developmental Screening Test scores, below two standard deviations was classified as delayed

Time frame: at 5 years

Developmental delay in gross motor function

Cerebral palsy, gross motor function classification system score ≥2

Time frame: at 2years

Developmental delay in gross motor function, 5y

Cerebral palsy, gross motor function classification system score ≥2

Data from ClinicalTrials.gov

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