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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Fundación de Ayuda a la Investigación sobre la Hipertensión pulmonar | UNKNOWN |
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Bronchopulmonary Dysplasia (BPD) is the most frequent disease related to a premature birth, 15-50% of very low birth newborns (<1500 gr.) will develop BPD. The prevalence of BPD is increasing due to the advances in neonatology, with a rise in the survival of smaller and more premature babies. The etiology of BPD is multifactorial, in which oxygen, maternal chorioamnionitis, insufficient pulmonary maturation etc. have an important role. These factors lead to a pathological development of the lung and pulmonary vessels, developing secondary Pulmonary Hypertension (PH). Nowadays there is no efficient treatment; this generates a important sanitary burden and a decrease in life quality. Multiple experimental models in mice have studied Mesenchymal Stem Cell (MSC) therapy as prevention of BPD, also recently some clinical trials have tried this therapy on premature newborns with promising results. Hypothesis: MSC therapy in patients at high risk of BPD prevents pulmonary lesions. Methods: The investigators have designed a clinical trial to evaluate the feasibility and security of MSC therapy in patients at high risk of developing BPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal Stem Cell (MSC) therapy | Experimental | There will only be one treatment arm to evaluate the security of the treatment with MSC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stem Cell (MSC) therapy | Biological | 3 doses of 5 million MSC will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia (Number of participants with adverse events) | Number of participants with adverse events as a measure of safety and tolerability | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker analysis (IL-1beta, IL-6, IP-10, INF-gamma, TGF beta, NLRP3, RAGE, HMGB1, VEGFA, GREMLIN1, sVEGFR1, IGF, ENDOTHELIN-1, SMPD-1, SP-D, SMPD3. | biomarkers will be measured in pg/ml | 24 months |
| Changes in the echocardiographic parameters related with PH and preterm birth, in patients treated with MSC (Number of participants with echocardiographic adverse events) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Jesus del Cerro, PhD | IRYCIS. Hospital Universitario Ramón y Cajal. Madrid. Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario A Coruña | A Coruña | Spain | ||||
| Hospital Clínico San Carlos |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Flattening of the interventricular septum will be the main parameter (tipe I, I-II, II, II-III OR III) |
| 24 months |
| Incidence of BPD and PH in very low birth weight babies treated with MSC | Diagnosed at 36 weeks of postmenstrual age | 24 months |
| Madrid |
| Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | Spain |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |