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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02274428
Other study ID # 2014-06-103
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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