NCT02274428

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

October 2, 2014

Last Update Submit

April 18, 2017

Conditions

Mesenchymal Stromal Cells

Keywords

intraventricular hemorrhage

Outcome Measures

Primary Outcomes (1)

  • unsuspected death or anaphylactic shock

    within 6 h after pneumostem transplantation

Secondary Outcomes (1)

  • Death or hydrocephalus required shunt operation

    First discharge home, maximum time frame : 1 year

Study Arms (1)

pneumostem group

OTHER

single arm, pneumostem treated infants

Drug: pneumostem

Interventions

pneumostemDRUG

human umbilical cord blood derived mesenchymal stem cells

pneumostem group

Eligibility Criteria

Age23 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • IVH grade 3-4, confirmed with brain ultrasonogram
  • within 7 days after IVH diagnosis

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Officials

  • Won Soon Park, M.D. Ph.D

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 24, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2016

Study Completion

December 1, 2016

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

KR(1)