Back to resultsEfficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)
Primary Purpose
Cell Transplantation
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pneumostem
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Cell Transplantation
Eligibility 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 a history of participating in other clinical studies
- Patient who is considered inappropriate to participate in the study by the investigator
Sites / Locations
- Samsung Medical CenterRecruiting
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
MSC group
Arm Description
Control group receives placebo medication (normal saline)
MSC group receives mesenchymal stem cells transplantation (Pneumostem)
Outcomes
Primary Outcome Measures
Death or shunt operation
Death or shunt operation
Secondary Outcome Measures
ventricular dilatation
volume ratio of ventricle to whole brain in the brain MRI
Death
Death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02890953
Brief Title
Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)
Official Title
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cell Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group receives placebo medication (normal saline)
Arm Title
MSC group
Arm Type
Experimental
Arm Description
MSC group receives mesenchymal stem cells transplantation (Pneumostem)
Intervention Type
Drug
Intervention Name(s)
Pneumostem
Other Intervention Name(s)
Umbilical cord blood derived mesenchymal stem cells
Intervention Description
direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
direct intracerebroventricular injection of normal saline via ventricular tap
Primary Outcome Measure Information:
Title
Death or shunt operation
Description
Death or shunt operation
Time Frame
until 40 weeks of corrected age
Secondary Outcome Measure Information:
Title
ventricular dilatation
Description
volume ratio of ventricle to whole brain in the brain MRI
Time Frame
until 40 weeks of corrected age
Title
Death
Description
Death
Time Frame
until 40 weeks of corrected age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility 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 a history of participating in other clinical studies
Patient who is considered inappropriate to participate in the study by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
So Yoon Ahn, MD. Ph.D
Phone
+821040380460
Email
soyoon.ahn@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Won Soon Park, MD. Ph.D
Phone
+821099333523
Email
ws123.park@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So Yoon Ahn, MD
Phone
+82-02-3410-3745
Email
yoon.ahn.neo@gmail.com
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won-Soon Park, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)
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