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. 2017 Nov 10;2017(11):CD011932. doi: 10.1002/14651858.CD011932.pub2

NCT02274428.

Trial name or title Phase 1 clinical trial of PNEUMOSTEM treatment in premature infants with intraventricular hemorrhage
Methods Single group assignment; not a randomized controlled trial
Participants Inclusion criteria:
  • 23 to 34 weeks

  • intraventricular hemorrhage grade 3 to 4, confirmed with brain ultrasonogram

  • within 7 days after intraventricular hemorrhage diagnosis


Exclusion criteria:
  • severe congenital anomaly

  • intrauterine intracranial bleeding

  • intracranial infection

  • severe congenital infection

  • active and uncontrolled infection, C‐reactive protein > 10 mg/dL

  • Platelet count < 50,000/mL

  • severe metabolic acidosis (pH < 7.1, Base excess < ‐20)

Interventions Drug: Pneumostem
Outcomes Primary outcome measures: unsuspected death or anaphylactic shock within 6 hours after Pneumostem transplantation.
 Secondary outcome measures: death or hydrocephalus requiring shunt operation.
Starting date  
Contact information  
Notes clinicaltrials.gov/ct2/show/NCT02274428
Study has passed its completion date and status has not been verified in more than 2 years.