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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02673788

Enrollment

Registered

2016-02-04

Start date

2016-01-31

Completion date

2023-12-31

Last updated

2019-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hemorrhages, Mesenchymal Stem Cells, Newborn Infant

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.

Interventions

OTHERobservation without intervention in this follow up study

observation without intervention in this follow up study

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 2 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Developmental disability	until 2 years old (corrected age)	scoring (category: gait, sitting, hand use, head control, communication, vision, hearing)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026