Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04003857
• Other study ID #: MP-CR-012-F/U
• Status: Recruiting
• Phase: Phase 2
• Start date: July 5, 2019
• Est. completion date: June 30, 2027

Study information

• Verified date: March 2023
• Source: Medipost Co Ltd.
• Contact: Eunyoung LEE
• Phone: 82234656748
• Email: ley0113[@]medi-post.co.kr
• 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 (NCT03392467) 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: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 60 Months

Eligibility

Inclusion Criteria:

• Subject who enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product

• 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®
A single intratracheal administration of PNEUMOSTEM® (1.0 x 10^7 cells/kg)
• normal saline
A single intratracheal administration of 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: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	6 months corrected age
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	12 months corrected age
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection is recorded and compared with control group	18 months corrected age
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	24 months corrected age
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	36 months after birth
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	39 months after birth
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	42 months after birth
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	45 months after birth
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	48 months after birth
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	51 months after birth
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	54 months after birth
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	57 months after birth
Primary	Respiratory outcome: Number of hospitalizations	Total number of hospitalizations and the number of hospital stay due to respiratory infection	60 months after birth
Secondary	Mortality	check whether patient is alive or dead at evaluation time point	6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Secondary	Growth measured by Z-score	Growth measured by Z-score	6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Secondary	Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST)	Neurological developmental status on Korean Developmental Screening Test for infants and children(K-DST)	6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Secondary	Deafness or Blindness	Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry	24 months corrected age
Secondary	Bayley Scales of Infant and Toddler Development (Third Edition)	Scale: cognitive, motor, language, social-emotional, adaptive behavior	18~24months corrected age, 36~42months after birth
Secondary	Gross Motor Function Classification System for Cerebral Palsy	Gross Motor Function Classification System for Cerebral Palsy	24 months corrected age
Secondary	Number of adverse events	Number of adverse events	6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Secondary	Number of admissions to Emergency Room (ER)	Total number of admissions to Emergency Room (ER) and number of admission to Emergency Room (ER) due to respiratory infection at each evaluation time point	6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
Secondary	Medical treatment records	whether or not, the patient is receiving medical treatment(use of oxygen, steroid, or bronchodilator, diuretics, Sildenafil) and if receiving treatment, the duration of the treatment at each evaluation time point	6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth