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NCT Number: NCT01897987

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

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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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

7 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center, Seoul, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PNEUMOSTEM®

Biological

Other names: Human umbilical cord blood-derived mesenchymal stem cells

Normal Saline

Biological

Primary outcomes

  1. Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection

    Time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age

Secondary outcomes

  1. Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator)

    Time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age

  2. Number of admissions to Emergency Room

    Time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age

    Total number of admissions to Emergency Room and number of admissions to Emergency Room due to resiratory problems

  3. Survival

    Time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age

  4. Growth measured by Z-score

    Time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age

  5. Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy

    Time frame: 24 months, corrected age

  6. Deafness or Blindness

    Time frame: 24 months, corrected age

  7. Number of adverse events

    Time frame: 6, 12, 24,36, 48, and 60 months, corrected age

  8. Significant changes in vital signs

    Time frame: 6, 12, 24, 36, 48, and 60 months, corrected age

  9. Significant changes in physical exam

    Time frame: 6, 12, 24, 36, 48, and 60 months, corrected age

Sponsors and collaborators

Lead sponsor

Medipost Co Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2013
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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