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

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ClinicalTrials.gov Identifier: NCT02890953
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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 : August 2019
Estimated Study Completion Date : December 2019
Arms and Interventions

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


Outcome Measures

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 ]
    Death


Eligibility Criteria

Information from the National Library of Medicine

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

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 severe intracranial hemorrhage ≥ grade 3 or 4
  • Patient with a history of participating in other clinical studies
  • Patient who is considered inappropriate to participate in the study by the investigator
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02890953


Contacts
Contact: So Yoon Ahn, MD. Ph.D +821040380460 soyoon.ahn@samsung.com
Contact: Won Soon Park, MD. Ph.D +821099333523 ws123.park@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: So Yoon Ahn, MD    +82-02-3410-3745    yoon.ahn.neo@gmail.com   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Principal Investigator: Won-Soon Park, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
More Information

Responsible Party: Won Soon Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02890953     History of Changes
Other Study ID Numbers: 2016-06-005
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No