Status:
COMPLETED
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
Lead Sponsor:
Samsung Medical Center
Conditions:
Mesenchymal Stromal Cells
Eligibility:
All Genders
23-34 years
Phase:
PHASE1
Brief 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, g...
Eligibility Criteria
Inclusion
- 23-34w
- IVH grade 3-4, confirmed with brain ultrasonogram
- within 7 days after IVH diagnosis
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02274428
Start Date
October 1 2014
End Date
December 1 2016
Last Update
April 19 2017
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea