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

Phase 1

Completed

• Conditions: Mesenchymal Stromal Cells
• Interventions: Drug: pneumostem

• Registration Number: NCT02274428
• Lead Sponsor: 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-24
• Primary Completion: 2016-02
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pneumostem group	pneumostem	single arm, pneumostem treated infants

Primary Outcome Measures

Name	Time	Method
unsuspected death or anaphylactic shock	within 6 h after pneumostem transplantation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of