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Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)
Sponsor: Samsung Medical Center
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.
Official title: Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)
Key Details
Gender
All
Age Range
Any - 28 Days
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2017-03-28
Completion Date
2025-12
Last Updated
2025-04-13
Healthy Volunteers
No
Conditions
Interventions
Pneumostem
direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap
Normal saline
direct intracerebroventricular injection of normal saline via ventricular tap
Locations (1)
Samsung Medical Center
Seoul, South Korea