Have you or your loved ones been diagnosed with bronchopulmonary dysplasia?

You may be eligible to participate in a bronchopulmonary dysplasia clinical trial.

Have you or your loved ones been diagnosed with bronchopulmonary dysplasia? You may be eligible to participate in a bronchopulmonary dysplasia clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Bronchopulmonary Dysplasia Clinical Trial

NCT01897987 | Interventional

Have you or your loved ones been diagnosed with bronchopulmonary dysplasia?

You may be eligible to participate in a bronchopulmonary dysplasia clinical trial.

Have you or your loved ones been diagnosed with bronchopulmonary dysplasia? You may be eligible to participate in a bronchopulmonary dysplasia clinical trial.

Completed

Male & Female

7 - 7

Months old

This study has recruited 62 Participants

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.

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Details for the study

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®<br /> versus placebo, for the treatment of BPD in premature infants. Subjects who participated in<br /> and completed the initial stage of the Phase II trial (NCT01828957) will be followed-up until<br /> 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Study 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