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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observation without intervention in this follow up study | Other | observation without intervention in this follow up study |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Bayley score (MDI, PDI) | until 2 years old (corrected age) | |
| Cerebral palsy | more than score 2 based on Gross Motor Function Classification System (GMFCS) score | until 2 years old (corrected age) |
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Inclusion Criteria:
Exclusion Criteria:
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Paitents who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42241571 | Derived | Yang M, Ahn SY, Sung SI, Chang YS, Park WS. Five-year follow-up outcomes after phase 1 trial of mesenchymal stromal cells for periventricular hemorrhagic infarction in preterm infants. Stem Cells Transl Med. 2026 May 18;15(6):szag030. doi: 10.1093/stcltm/szag030. |
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| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Developmental disability | scoring (category: gait, sitting, hand use, head control, communication, vision, hearing) | until 2 years old (corrected age) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |