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

April 18, 2017 updated by: Won Soon Park, Samsung Medical Center
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
unsuspected death or anaphylactic shock
Time Frame: within 6 h after pneumostem transplantation
within 6 h after pneumostem transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death or hydrocephalus required shunt operation
Time Frame: First discharge home, maximum time frame : 1 year
outcome measurement time frame would not exceed 1 year after birth
First discharge home, maximum time frame : 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2014

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (ESTIMATE)

October 24, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-06-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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