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Trial record 20 of 799 for:    Interventional Studies | mesenchymal

Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage

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ClinicalTrials.gov Identifier: NCT02274428
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Won Soon Park, Samsung Medical Center

Brief Summary:
Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical cord blood derived mesenchymal stem cells) in the premature infants with intraventricular hemorrhage (IVH, grade 3-4)

Condition or disease Intervention/treatment Phase
Mesenchymal Stromal Cells Drug: pneumostem Phase 1

Study Type : Interventional
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
Actual Study Start Date : October 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
pneumostem group
single arm, pneumostem treated infants
Drug: pneumostem
human umbilical cord blood derived mesenchymal stem cells




Primary Outcome Measures :
  1. unsuspected death or anaphylactic shock [ Time Frame: within 6 h after pneumostem transplantation ]

Secondary Outcome Measures :
  1. Death or hydrocephalus required shunt operation [ Time Frame: First discharge home, maximum time frame : 1 year ]
    outcome measurement time frame would not exceed 1 year after birth



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Ages Eligible for Study:   23 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 23-34w
  • IVH grade 3-4, confirmed with brain ultrasonogram
  • within 7 days after IVH diagnosis

Exclusion Criteria:

  • severe congenital anomaly
  • intrauterine intracranial bleeding
  • intracranial infection
  • severe congenital infection
  • active and uncontrolled infection, CRP>10mg/dl
  • Platelet count <50,000/ml
  • severe metabolic acidosis (PH<7.1, BE<-20)

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): NCT02274428


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Won Soon Park, M.D. Ph.D Samsung Medical Center

Responsible Party: Won Soon Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02274428     History of Changes
Other Study ID Numbers: 2014-06-103
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Won Soon Park, Samsung Medical Center:
intraventricular hemorrhage

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