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

Samsung Medical Center9 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Intracranial Hemorrhages Mesenchymal Stem Cells Newborn Infant

Interventions

observation without intervention in this follow up studyOTHER

observation without intervention in this follow up study

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH. Exclusion Criteria: * Patients who did not enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

newly developed brain tumor

Using brain MRI, it is to assess the risk of tumorigenicity of donor stem cells.

Time frame: until 2 years old (corrected age)

Secondary Outcomes

Bayley score (MDI, PDI)

Time frame: until 2 years old (corrected age)

Cerebral palsy

more than score 2 based on Gross Motor Function Classification System (GMFCS) score

Time frame: until 2 years old (corrected age)

Developmental disability

scoring (category: gait, sitting, hand use, head control, communication, vision, hearing)

Time frame: until 2 years old (corrected age)

Data from ClinicalTrials.gov

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