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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02274428

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Mesenchymal Stromal Cells	Drug: pneumostem	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: pneumostem group single arm, pneumostem treated infants	Drug: pneumostem human umbilical cord blood derived mesenchymal stem cells

Arm

Intervention/Treatment

Other: pneumostem group

single arm, pneumostem treated infants

Drug: pneumostem

human umbilical cord blood derived mesenchymal stem cells

Outcome Measures

Primary Outcome Measures

unsuspected death or anaphylactic shock [within 6 h after pneumostem transplantation]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Weeks to 34 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator: Won Soon Park, M.D. Ph.D, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Won Soon Park, Professor, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT02274428

Other Study ID Numbers:

2014-06-103

First Posted:

Oct 24, 2014

Last Update Posted:

Apr 19, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Won Soon Park, Professor, Samsung Medical Center

intraventricular hemorrhage

Additional relevant MeSH terms:

Hemorrhage

Study Results

No Results Posted as of Apr 19, 2017