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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-28

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Control group receives placebo medication (normal saline)

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

direct intracerebroventricular injection of normal saline via ventricular tap

MSC group

MSC group receives mesenchymal stem cells transplantation (Pneumostem)

Group Type EXPERIMENTAL

Pneumostem

Intervention Type DRUG

direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap

Interventions

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Pneumostem

direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap

Intervention Type DRUG

Normal saline

direct intracerebroventricular injection of normal saline via ventricular tap

Intervention Type DRUG

Other Intervention Names

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Umbilical cord blood derived mesenchymal stem cells

Eligibility Criteria

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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

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No