Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
Phase 1
Completed
- Conditions
- Mesenchymal Stromal Cells
- Interventions
- Drug: pneumostem
- Registration Number
- NCT02274428
- Lead Sponsor
- Samsung Medical Center
- 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, grade 3-4)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- 23-34w
- IVH grade 3-4, confirmed with brain ultrasonogram
- within 7 days after IVH diagnosis
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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)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description pneumostem group pneumostem single arm, pneumostem treated infants
- Primary Outcome Measures
Name Time Method unsuspected death or anaphylactic shock within 6 h after pneumostem transplantation
- Secondary Outcome Measures
Name Time Method Death or hydrocephalus required shunt operation First discharge home, maximum time frame : 1 year outcome measurement time frame would not exceed 1 year after birth
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of