Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical cord blood derived mesenchymal stem cells) in the premature infants with intraventricular hemorrhage (IVH, grade 3-4)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center

Criteria

Inclusion Criteria:

• 23-34w

• IVH grade 3-4, confirmed with brain ultrasonogram

• within 7 days after IVH diagnosis

Exclusion Criteria:

• severe congenital anomaly

• intrauterine intracranial bleeding

• intracranial infection

• severe congenital infection

• active and uncontrolled infection, CRP>10mg/dl

• Platelet count <50,000/ml

• severe metabolic acidosis (PH<7.1, BE<-20)