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

Intracranial Hemorrhages Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02673788
• Other study ID #: 2015-09-102
• Status: Active, not recruiting
• Start date: January 2016
• Est. completion date: December 2023

Study information

• Verified date: April 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Hemorrhages
• Mesenchymal Stem Cells
• Newborn Infant

Intervention

Other:
• observation without intervention in this follow up study
observation without intervention in this follow up study

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	newly developed brain tumor	Using brain MRI, it is to assess the risk of tumorigenicity of donor stem cells.	until 2 years old (corrected age)
Secondary	Bayley score (MDI, PDI)		until 2 years old (corrected age)
Secondary	Cerebral palsy	more than score 2 based on Gross Motor Function Classification System (GMFCS) score	until 2 years old (corrected age)
Secondary	Developmental disability	scoring (category: gait, sitting, hand use, head control, communication, vision, hearing)	until 2 years old (corrected age)