Back to resultsPhase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
Primary Purpose
Mesenchymal Stromal Cells
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pneumostem
Sponsored by
About this trial
This is an interventional treatment trial for Mesenchymal Stromal Cells focused on measuring intraventricular hemorrhage
Eligibility 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)
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
pneumostem group
Arm Description
single arm, pneumostem treated infants
Outcomes
Primary Outcome Measures
unsuspected death or anaphylactic shock
Secondary Outcome Measures
Death or hydrocephalus required shunt operation
outcome measurement time frame would not exceed 1 year after birth
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02274428
Brief Title
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
Official Title
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenchymal Stromal Cells
Keywords
intraventricular hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pneumostem group
Arm Type
Other
Arm Description
single arm, pneumostem treated infants
Intervention Type
Drug
Intervention Name(s)
pneumostem
Intervention Description
human umbilical cord blood derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
unsuspected death or anaphylactic shock
Time Frame
within 6 h after pneumostem transplantation
Secondary Outcome Measure Information:
Title
Death or hydrocephalus required shunt operation
Description
outcome measurement time frame would not exceed 1 year after birth
Time Frame
First discharge home, maximum time frame : 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Soon Park, M.D. Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
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