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Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage

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.
ClinicalTrials.gov Identifier: NCT02673788
Recruitment Status : Active, not recruiting
First Posted : February 4, 2016
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Won Soon Park, Samsung Medical Center

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.

Condition or disease Intervention/treatment
Intracranial Hemorrhages Mesenchymal Stem Cells Newborn Infant Other: observation without intervention in this follow up study

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Study Type : Observational
Estimated Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage
Study Start Date : January 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding


Intervention Details:
  • Other: observation without intervention in this follow up study
    observation without intervention in this follow up study


Primary Outcome Measures :
  1. newly developed brain tumor [ Time Frame: until 2 years old (corrected age) ]
    Using brain MRI, it is to assess the risk of tumorigenicity of donor stem cells.


Secondary Outcome Measures :
  1. Bayley score (MDI, PDI) [ Time Frame: until 2 years old (corrected age) ]
  2. Cerebral palsy [ Time Frame: until 2 years old (corrected age) ]
    more than score 2 based on Gross Motor Function Classification System (GMFCS) score

  3. Developmental disability [ Time Frame: until 2 years old (corrected age) ]
    scoring (category: gait, sitting, hand use, head control, communication, vision, hearing)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Paitents who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT02673788


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Won Soon Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02673788     History of Changes
Other Study ID Numbers: 2015-09-102
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hemorrhage
Intracranial Hemorrhages
Cerebral Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases