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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02890953
Recruitment Status : Unknown
Verified April 2019 by Won Soon Park, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : September 7, 2016
Last Update Posted : April 11, 2019
Information provided by (Responsible Party):
Won Soon Park, Samsung Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cell Transplantation Drug: Pneumostem Drug: Normal saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

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 Name: Umbilical cord blood derived mesenchymal stem cells

Primary Outcome Measures :
  1. Death or shunt operation [ Time Frame: until 40 weeks of corrected age ]
    Death or shunt operation

Secondary Outcome Measures :
  1. ventricular dilatation [ Time Frame: until 40 weeks of corrected age ]
    volume ratio of ventricle to whole brain in the brain MRI

  2. Death [ Time Frame: until 40 weeks of corrected age ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02890953

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Contact: So Yoon Ahn, MD. Ph.D +821040380460
Contact: Won Soon Park, MD. Ph.D +821099333523

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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: So Yoon Ahn, MD    +82-02-3410-3745   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Principal Investigator: Won-Soon Park, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Won Soon Park, Professor, Samsung Medical Center Identifier: NCT02890953    
Other Study ID Numbers: 2016-06-005
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications