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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02673788
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Duration (Months): 95
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Hemorrhages; Mesenchymal Stem Cells; Newborn Infant	Other: observation without intervention in this follow up study

Study Design

• Study Type: Observational
• Anticipated Enrollment: 9 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage
• Study Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Bayley score (MDI, PDI) [until 2 years old (corrected age)]

2. Cerebral palsy [until 2 years old (corrected age)]

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

3. Developmental disability [until 2 years old (corrected age)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 2 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Won Soon Park, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT02673788
• Other Study ID Numbers: 2015-09-102
• First Posted: Feb 4, 2016
• Last Update Posted: Apr 9, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Intracranial Hemorrhages; Hemorrhage

Study Results

No Results Posted as of Apr 9, 2019