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

This study is currently recruiting participants.
Verified April 2017 by Won Soon Park, Samsung Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02890953
First Posted: September 7, 2016
Last Update Posted: April 5, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Won Soon Park, Samsung Medical Center
  Purpose
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 Intervention Phase
Cell Transplantation Drug: Pneumostem Drug: Normal saline Phase 2

Study Type: Interventional
Study Design: 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)

Further study details as provided by Won Soon Park, Samsung Medical Center:

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


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

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


Estimated Enrollment: 22
Actual Study Start Date: March 28, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


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 Submitted: August 31, 2016
First Posted: September 7, 2016
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