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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumostem® | Experimental | A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg) |
|
| normal saline | Placebo Comparator | A single intratracheal administration of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumostem® | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection | 6, 12, 18, 24, 36, 48, and 60 months, corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator) | 6, 12, 18, 24, 36, 48, and 60 months, corrected age | |
| Number of admissions to Emergency Room | Total number of admissions to Emergency Room and number of admissions to Emergency Room due to resiratory problems |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wonsoon Park, MD, PhD | Department of Pediatrics, Samsung Medical Center | Principal Investigator |
| Ai-Rhan Kim, MD, PhD | Department of Neonatology, Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea | ||||
| Samsung Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37604693 | Derived | Ahn SY, Chang YS, Lee MH, Sung S, Kim AR, Park WS. Five-year follow-up of phase II trial of stromal cells for bronchopulmonary dysplasia. Thorax. 2023 Nov;78(11):1105-1110. doi: 10.1136/thorax-2022-219622. Epub 2023 Aug 21. |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| normal saline |
| Biological |
|
| 6, 12, 18, 24, 36, 48, and 60 months, corrected age |
| Survival | 6, 12, 18, 24, 36, 48, and 60 months, corrected age |
| Growth measured by Z-score | 6, 12, 18, 24, 36, 48, and 60 months, corrected age |
| Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy | 24 months, corrected age |
| Deafness or Blindness | 24 months, corrected age |
| Number of adverse events | 6, 12, 24,36, 48, and 60 months, corrected age |
| Significant changes in vital signs | 6, 12, 24, 36, 48, and 60 months, corrected age |
| Significant changes in physical exam | 6, 12, 24, 36, 48, and 60 months, corrected age |
| Seoul |
| South Korea |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |