Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage

April 7, 2019 updated by: Won Soon Park, Samsung Medical Center
This is a follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

9

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

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Paitents who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.

Description

Inclusion Criteria:

  • Patients who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.

Exclusion Criteria:

  • Patients who did not enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
newly developed brain tumor
Time Frame: until 2 years old (corrected age)
Using brain MRI, it is to assess the risk of tumorigenicity of donor stem cells.
until 2 years old (corrected age)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bayley score (MDI, PDI)
Time Frame: until 2 years old (corrected age)
until 2 years old (corrected age)
Cerebral palsy
Time Frame: until 2 years old (corrected age)
more than score 2 based on Gross Motor Function Classification System (GMFCS) score
until 2 years old (corrected age)
Developmental disability
Time Frame: until 2 years old (corrected age)
scoring (category: gait, sitting, hand use, head control, communication, vision, hearing)
until 2 years old (corrected age)

Collaborators and Investigators

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

Sponsor

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

January 1, 2016

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 7, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-09-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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