Mesenchymal Stem Cell (MSC) therapy
Biological3 doses of 5 million MSC will be administered
NCT Number: NCT02443961
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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Notify Me1 week–28 week
All sexes
Interventional
Phase 1
Hospital Universitario A Coruña, A Coruña, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 doses of 5 million MSC will be administered
Time frame: 24 months
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 24 months
biomarkers will be measured in pg/ml
Time frame: 24 months
Flattening of the interventricular septum will be the main parameter (tipe I, I-II, II, II-III OR III)
Time frame: 24 months
Diagnosed at 36 weeks of postmenstrual age
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Other
Clinical Trial: Security and Feasibility of Mesenchymal Stem Cell Therapy in Treatment and Prevention of Bronchopulmonary Dysplasia in Preterm Babies
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