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The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing Pneumostem-treated group with a control group.
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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 |
|---|---|---|
| Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA | Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA | 36 weeks PMA |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation duration | 36 weeks PMA | |
| Incidence of BPD | 28-days since birth | |
| Survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won-Soon Park, MD, PhD | Department of Pediatrics, Samsung Medical Center | Principal Investigator |
| Ai-Rhan Kim | 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 |
|---|---|---|---|
| 33876883 | Derived | Ahn SY, Chang YS, Lee MH, Sung SI, Lee BS, Kim KS, Kim AR, Park WS. Stem cells for bronchopulmonary dysplasia in preterm infants: A randomized controlled phase II trial. Stem Cells Transl Med. 2021 Aug;10(8):1129-1137. doi: 10.1002/sctm.20-0330. Epub 2021 Apr 20. |
| Label | URL |
|---|---|
| Related Info | View source |
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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 |
| Other |
|
| 28-days since birth, 36 weeks PMA, and termination of the trial |
| Duration of ventilator dependence | Week 24 |
| Duration of CPAP treatment | Week 24 |
| Postnatal steroid use (%) for the purpose of ventilator weaning | Week 24 |
| Cumulative duration of oxygen use | Week 24 |
| Incidence of Retinopathy of Prematurity (ROP) of Grade III or more | Week 24 |
| Retinopathy of Prematurity (ROP) that require treatment with avastin or laser | Week 24 |
| Growth velocity (Z-score) | Week 24 |
| Length of stay prior to the first discharge from the hospital | duration of the hospital stay, an expected average of approximately 3 months since birth |
| Incidence of adverse events | Week 24 |
| Clinically significant laboratory findings | Week 24 |
| Incidence of pneumothorax that require intubation | Week 24 |
| Incidence of moderate to severe pulmonary hemorrhage | Week 24 |
| Incidence of intraventricular hemorrhage of grade 3 or more | Week 24 |
| 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 |