Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premat... | NCT02274428

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

NCT02274428

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Apr 19, 2017Actual

Enrollment

9Actual

Phase

Phase 1

Conditions

Mesenchymal Stromal Cells

Interventions

pneumostem

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014Actual

Primary Completion Date

Feb 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Oct 2, 2014

First Submission Date that Met QC Criteria

Oct 23, 2014

First Posted Date

Oct 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2017

Last Update Posted Date

Apr 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pneumostem group	Other	single arm, pneumostem treated infants	Drug: pneumostem

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pneumostem	Drug	human umbilical cord blood derived mesenchymal stem cells	pneumostem group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
unsuspected death or anaphylactic shock		within 6 h after pneumostem transplantation

Secondary Outcomes

Measure	Description	Time Frame
Death or hydrocephalus required shunt operation	outcome measurement time frame would not exceed 1 year after birth	First discharge home, maximum time frame : 1 year

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Weeks

Maximum Age

34 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Won Soon Park, M.D. Ph.D	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided