Intracranial Hemorrhages Clinical Trial
Official title:
Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage
Verified date | April 2019 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
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) |
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