Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage

• Conditions: Intracranial Hemorrhages; Mesenchymal Stem Cells; Newborn Infant

• Registration Number: NCT02673788
• Lead Sponsor: Samsung Medical Center

Brief Summary

This is a follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage.

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 Start: 2016-01
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-07
• Last Update Posted: 2019-04-09
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

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

Inclusion Criteria

• Patients who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.

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Exclusion Criteria

• Patients who did not enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
newly developed brain tumor	until 2 years old (corrected age)	Using brain MRI, it is to assess the risk of tumorigenicity of donor stem cells.

Secondary Outcome Measures

Name	Time	Method
Developmental disability	until 2 years old (corrected age)	scoring (category: gait, sitting, hand use, head control, communication, vision, hearing)
Bayley score (MDI, PDI)	until 2 years old (corrected age)
Cerebral palsy	until 2 years old (corrected age)	more than score 2 based on Gross Motor Function Classification System (GMFCS) score

Trial Locations

Locations (1)

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