NCT02673788

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

6.9 years

First QC Date

January 26, 2016

Last Update Submit

April 7, 2019

Conditions

Intracranial HemorrhagesMesenchymal Stem CellsNewborn Infant

Outcome Measures

Primary Outcomes (1)

  • newly developed brain tumor

    Using brain MRI, it is to assess the risk of tumorigenicity of donor stem cells.

    until 2 years old (corrected age)

Secondary Outcomes (3)

  • Bayley score (MDI, PDI)

    until 2 years old (corrected age)

  • Cerebral palsy

    until 2 years old (corrected age)

  • Developmental disability

    until 2 years old (corrected age)

Interventions

observation without intervention in this follow up studyOTHER

observation without intervention in this follow up study

Eligibility Criteria

Age6 Months - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Intracranial Hemorrhages

Interventions

ObservationMethods

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 4, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)