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

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Bronchopulmonary dysplasia
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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