Brief Title
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
Official Title
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed the Initial Stage of PNEUMOSTEM® Phase-II Clinical Trial
Brief 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.
Detailed 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.
Study Type
Interventional
Primary Outcome
Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection
Secondary Outcome
Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator)
Condition
Bronchopulmonary Dysplasia
Intervention
Pneumostem®
Study Arms / Comparison Groups
Pneumostem®
Description: A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
62
Start Date
January 2014
Completion Date
March 2020
Primary Completion Date
March 2020
Eligibility Criteria
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
Gender
All
Ages
7 Months - 7 Months
Accepts Healthy Volunteers
No
Contacts
Wonsoon Park, MD, PhD, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01897987
Organization ID
MP-CR-009-FU
Responsible Party
Sponsor
Study Sponsor
Medipost Co Ltd.
Study Sponsor
Wonsoon Park, MD, PhD, Principal Investigator, Department of Pediatrics, Samsung Medical Center
Verification Date
August 2020