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The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.
UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for prevention of Bronchopulmonary dysplasia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UMC119-01 | Experimental | UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Umbilical Cord Derived-Mesenchymal Stem Cells | Biological | Cohort 1 : 3 million cells/kg ; Cohort 2 : 10 million cells/kg ; Cohort 3 : 30 million cells/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and frequency of adverse events related to administration of UMC119-01. | • The incidence and frequency of adverse events (AEs) and serious adverse events (SAEs), including their relationship to the administration of UMC119 01. | 3 months from the day of administration |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects who died from any cause during the study. | The percentage of subjects who died from any cause during the study. | 3 months from the day of administration |
| Changes of the oxygen saturation. |
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Inclusion Criteria:
Neonatal infants who fulfil all of the following criteria will be enrolled:
Exclusion Criteria:
Neonatal infants who meet any of the following criteria will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Liao, MS | Contact | +886-2-8978-7777 | 19965 | claire.liao@meridigen.com |
| Joseph Chen | Contact | +886-2-8978-7777 | 19905 | joseph.chen@meridigen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Chen-Kung University Hospital | Recruiting | Tainan | Taiwan |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Changes from baseline of the oxygen saturation.
| 3 months from the day of administration |
| Changes of chest x-ray findings in participants before and after administration. | Changes from baseline to 3 months of chest x-ray findings in participants before and after administration. | 3 months from the day of administration |
| Changes of inflammatory markers (pg/ml) before and after administration. | Changes from baseline of inflammatory markers (pg/ml) . | 3 days and 7 days after administration |
| Comparison of the incidence and severity of preterm children's complications in participants before and after administration. | Comparison of the incidence and severity of preterm children's complications in participants before and after administration. | 3 months from the day of administration |
| The number of days of intubation, or where ventilator or oxygen therapy. | The number of days of intubation, or where ventilator or oxygen therapy. | 3 months from the day of administration |
| Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA). | Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA). | 36 weeks postmenstrual age (PMA) |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |