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

Mesenchymal Stromal Cells Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274428
• Other study ID #: 2014-06-103
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2014
• Last updated: April 18, 2017
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 34 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Mesenchymal Stromal Cells

Intervention

Drug:
• pneumostem
human umbilical cord blood derived mesenchymal stem cells

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	unsuspected death or anaphylactic shock		within 6 h after pneumostem transplantation
Secondary	Death or hydrocephalus required shunt operation	outcome measurement time frame would not exceed 1 year after birth	First discharge home, maximum time frame : 1 year