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| Name | Class |
|---|---|
| Medipost Co Ltd. | INDUSTRY |
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This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.
Bronchopulmonary dysplasia (BPD) is the most common cause of death for premature newborns with low birth weights. In addition, many children who recover from the disease suffer from various complications such as prolonged hospitalization, pulmonary hypertension, and failure to thrive.
It has been reported that bone marrow-derived mesenchymal stem cells (BM-MSC) can differentiate into pulmonary epithelial and pulmonary endothelial cells. Some animal studies showed that BM-MSCs differentiate into bronchial cells and type 2 pneumocytes in rats with pneumonia and improve the fibrosis that occur after administration of bleomycin. Based on the findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged lung as well as BPD that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes, and so on.
PNEUMOSTEM® consists of human umbilical cord blood-derived mesenchymal stem cells and is intended to treat BPD in premature infants. This is a long term follow-up study of the earlier part of the phase I clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumostem® | Low Dose Group (3 subjects): 1.0 x 10^7 cells/kg, High Dose Group (6 subjects): 2.0 x 10^7 cells/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumostem® | Biological | A single intratracheal administration Low Dose Group (3 patients): 1.0 x 10^7 cells/kg, High Dose Group (6 patients): 2 x 10^7 cells/kg * The subjects were administered with Pneumostem® in the earlier part of the phase I study. No drugs/biologics are administered during this part of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Adverse Drug Reaction | Blood test, chest x-ray, physical exam | at corrected age of 21 months (±3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological development test outcome from the subjects who were treated with Pneumostem®, compared with the patients who suffered from the same conditions but not treated with Pneumostem® | Bayely test results of the 9 subjects who were treated with Pneumostem® during the early part of the Phase I study. The results of Brain MRI study performed at corrected age of 18-24 months. | at corrected age of 10 months (±2 months) and 21 months (±3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Infants who enrolled in the study of phase 1 clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia. (NCT01297205)
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| Name | Affiliation | Role |
|---|---|---|
| Won-Soon Park, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea | |||
| Samsung Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28341525 | Derived | Ahn SY, Chang YS, Kim JH, Sung SI, Park WS. Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia. J Pediatr. 2017 Jun;185:49-54.e2. doi: 10.1016/j.jpeds.2017.02.061. Epub 2017 Mar 21. |
| Label | URL |
|---|---|
| Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia | View source |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D006965 | Hyperplasia |
| D055397 | Ventilator-Induced Lung Injury |
| D010335 | Pathologic Processes |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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|
| Growth | Body weight, Head circumference, Height : growth percentile | Corrected gestational age of 4-6months, 8-12months, 18-24months |
| Seoul |
| South Korea |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
| D013568 | Pathological Conditions, Signs and Symptoms |