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Clinical Trial: Security and Feasibility of Mesenchymal Stem Cell Therapy in Treatment and Prevention of Bronchopulmonary Dysplasia in Preterm Babies
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Hospital Universitario A Coruña
A Coruña, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Start Date
April 2, 2019
Primary Completion Date
April 2, 2020
Completion Date
July 7, 2022
Last Updated
March 17, 2025
10
ACTUAL participants
Mesenchymal Stem Cell (MSC) therapy
BIOLOGICAL
Lead Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06342752