Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)

Phase 2

• Conditions: Cell Transplantation
• Interventions: Drug: Normal saline; Drug: Pneumostem

• Registration Number: NCT02890953
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-07
• Study Start: 2017-03-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-11
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• IVH grade 3-4
• age : within postnatal day 28
• gestational age: 23-<34 weeks

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal saline	Control group receives placebo medication (normal saline)
MSC group	Pneumostem	MSC group receives mesenchymal stem cells transplantation (Pneumostem)

Primary Outcome Measures

Name	Time	Method
Death or shunt operation	until 40 weeks of corrected age	Death or shunt operation

Secondary Outcome Measures

Name	Time	Method
ventricular dilatation	until 40 weeks of corrected age	volume ratio of ventricle to whole brain in the brain MRI
Death	until 40 weeks of corrected age	Death

Trial Locations

Locations (1)

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