Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)

April 10, 2019 updated by: Won Soon Park, Samsung Medical Center

Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)

The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Won-Soon Park, MD, PhD

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

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • IVH grade 3-4
  • age : within postnatal day 28
  • gestational age: 23-<34 weeks

Exclusion Criteria:

  • Patient with severe congenital abnormalities
  • Patient with antenatal brain hemorrhage
  • Patient with asphyxia or Hypoxic ischemic encepalophathy
  • Patient with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
  • Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
  • Patient withCRP > 30 mg/dL; Severe sepsis or shock
  • Patient with a history of participating in other clinical studies
  • Patient who is considered inappropriate to participate in the study by the investigator

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Control group receives placebo medication (normal saline)
Drug: Normal saline
direct intracerebroventricular injection of normal saline via ventricular tap
Experimental: MSC group
MSC group receives mesenchymal stem cells transplantation (Pneumostem)
Drug: Pneumostem
direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap
Other Names:
  • Umbilical cord blood derived mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death or shunt operation
Time Frame: until 40 weeks of corrected age
Death or shunt operation
until 40 weeks of corrected age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ventricular dilatation
Time Frame: until 40 weeks of corrected age
volume ratio of ventricle to whole brain in the brain MRI
until 40 weeks of corrected age
Death
Time Frame: until 40 weeks of corrected age
Death
until 40 weeks of 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 (Actual)

March 28, 2017

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-06-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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