Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Follow-up Safety and Efficacy Evaluation on Subjects Who Completed the Initial Stage of PNEUMOSTEM® Phase-II Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897987
• Other study ID #: MP-CR-009-FU
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: March 2020

Study information

• Verified date: August 2020
• Source: Medipost Co Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT01828957) will be followed-up until 60 months of corrected age.

Description:

Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: corrected age of 6, 12,18, 24, 36, 48, and 60 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Months to 7 Months

Eligibility

Inclusion Criteria:

• Subject who completed the safety and efficacy evaluations in Pneumostem Phase II clinical trial

• Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

Exclusion Criteria:

• Subject whose parent or legal representative does not agree to participate in the study

• subject who is considered inappropriate to participate in the study by the investigator

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Biological:
• Pneumostem®

• normal saline

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medipost Co Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection		6, 12, 18, 24, 36, 48, and 60 months, corrected age
Secondary	Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator)		6, 12, 18, 24, 36, 48, and 60 months, corrected age
Secondary	Number of admissions to Emergency Room	Total number of admissions to Emergency Room and number of admissions to Emergency Room due to resiratory problems	6, 12, 18, 24, 36, 48, and 60 months, corrected age
Secondary	Survival		6, 12, 18, 24, 36, 48, and 60 months, corrected age
Secondary	Growth measured by Z-score		6, 12, 18, 24, 36, 48, and 60 months, corrected age
Secondary	Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy		24 months, corrected age
Secondary	Deafness or Blindness		24 months, corrected age
Secondary	Number of adverse events		6, 12, 24,36, 48, and 60 months, corrected age
Secondary	Significant changes in vital signs		6, 12, 24, 36, 48, and 60 months, corrected age
Secondary	Significant changes in physical exam		6, 12, 24, 36, 48, and 60 months, corrected age