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

NCT02890953 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-04-13

No results posted yet for this study

Summary

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.

Conditions

  • Cell Transplantation

Interventions

DRUG

Pneumostem

direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap

DRUG

Normal saline

direct intracerebroventricular injection of normal saline via ventricular tap

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • So Yoon Ahn, MD. Ph.D · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-28
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02890953 on ClinicalTrials.gov