Pneumostem: direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap
Normal saline: direct intracerebroventricular injection of normal saline via ventricular tap
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.
Eligibility
Sex
ALL
Min age
—
Max age
28 Days
Healthy volunteers
No
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
Primary outcome measure(s)
Shunt or death — 40 weeks of corrected age Shunt operation or death
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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