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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center

Criteria

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