[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536851":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":67,"studyPopulation":59,"armGroups":68,"interventions":86,"overallOfficials":97,"centralContacts":102,"locations":111,"responsibleParty":193,"collaborators":59,"id":195,"slug":59,"hasResults":196,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":59,"eligibilityCriteria":200,"healthyVolunteers":196,"sex":201,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":59,"studyType":207,"phases":208,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":114,"whyStopped":59,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":59},[9,13],{"measure":10,"description":11,"timeFrame":12},"Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia","Number of patients with adverse events during the infusion time and during all study; and comorbilities due to preterm birth.","24 months",{"measure":14,"description":15,"timeFrame":12},"feasibility variable","Number of days of life from birth to administration of the first dose and number of days of life in successive doses.",[17,20,23,26,29,32,35,38,41,43,46,48,51,54,57],{"measure":18,"description":19,"timeFrame":12},"Incidence of BPD and PH in very low birth weight babies treated with MSC","Status on week 36 of post-menstrual age",{"measure":21,"description":22,"timeFrame":12},"Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen","(No BPD\u002Fgrade 1\u002Fgrade 2\u002Fgarde 3)",{"measure":24,"description":25,"timeFrame":12},"Exitus on week 36 and 40 of post-menstrual age or at hospital discharge","(Yes\u002FNo)",{"measure":27,"description":28,"timeFrame":12},"Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death.","(sepsis confirmed by blood culture, treated patent ductus arteriosus, non-pharmacological ductal closure, necrotising enterocolitis, isolated bowel perforation, intraventricular haemorrhage ≥ 2, retinopathy ≥ grade 2)",{"measure":30,"description":31,"timeFrame":12},"Biomarker analysis (IL-1beta, IL-6, IL8, TGF beta, TNF alfa, GM-CSF, NLRP3, RAGE, HMGB1, VEGF, HGF, GREMLIN1, sVEGFR1, SP-D, SMPD1, SMPD3, IsoPs, IsoFs, NeuroPs, NeuroFs, miRNAs).","biomarkers will be measured in pg\u002Fml",{"measure":33,"description":34,"timeFrame":12},"Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy.","NO PH (type I less 35%), MILD PH (type I-II between 35-50%) , MODERATE PH (type II between 50-70%) and SEVERE PH ( type II-III, more than 70%)",{"measure":36,"description":37,"timeFrame":12},"Changes in modified respirator score during therapy and up to week 36 of port-menstrual age","0 - 13 (min- max value). Higher score means worse outcome.",{"measure":39,"description":40,"timeFrame":12},"Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age","0-30 (min- max value). Higher score means worse outcome.",{"measure":42,"description":42,"timeFrame":12},"Date of hospital discharge and respiratory care at discharge.",{"measure":44,"description":45,"timeFrame":12},"Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2).","Number if patients that need supplemental O2",{"measure":47,"description":47,"timeFrame":12},"Duration of invasive and non-invasive mechanical ventilation.",{"measure":49,"description":50,"timeFrame":12},"Use of postnatal corticosteroids indicated","For the treatment or prevention of BPD",{"measure":52,"description":53,"timeFrame":12},"Respiratory readmission rates.","During the first year",{"measure":55,"description":56,"timeFrame":12},"Bayley Neurodevelopmental Scale at 24 months","Evaluation of cognitive developement, languaje developement and motor developement.",{"measure":58,"description":58,"timeFrame":12},"Date and cause of death.",null,{"allocation":61,"interventionModel":62,"interventionModelDescription":63,"primaryPurpose":64,"observationalModel":59,"timePerspective":59,"maskingInfo":65},"RANDOMIZED","PARALLEL","Parallel Group Assignment","TREATMENT",{"masking":66,"maskingDescription":59,"whoMasked":59},"NONE","Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly, and it is a disease that is nowadays increasing due to the improvement in the survival of this patients (affecting 15-50% of them).\n\nIn the Fase I Clinical Trial, the use of allogeneic fetal stem mesenchymal cells from umbilical cord proved to be safe, with no mortality or Adverse Events reported. The Fase II Clinical Trial is based in the hypothesis that the administation of mesenchymal stem cells is not only safe but feasible and can help reducing the chance of a preterm newborn patient developing BPD.",[69,75,81],{"label":70,"type":71,"description":72,"interventionNames":73},"Control","ACTIVE_COMPARATOR","Standard cell therapy (control group)",[74],"Biological: Control",{"label":76,"type":77,"description":78,"interventionNames":79},"Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions","EXPERIMENTAL","Treatment: three infusions of MSC 5x10\\^6\u002FKg",[80],"Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions",{"label":82,"type":77,"description":83,"interventionNames":84},"Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions","Treatment: six infusions of MSC 5x10\\^6\u002FKg",[85],"Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions",[87,91,94],{"type":88,"name":70,"description":89,"armGroupLabels":90,"otherNames":59},"BIOLOGICAL","Standard treatment",[70],{"type":88,"name":76,"description":92,"armGroupLabels":93,"otherNames":59},"3 doses of 5 million MSC will be administered",[76],{"type":88,"name":82,"description":95,"armGroupLabels":96,"otherNames":59},"6 doses of 5 million MSC will be administered",[82],[98],{"name":99,"affiliation":100,"role":101},"María Jesús del Cerro, PhD","IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.","PRINCIPAL_INVESTIGATOR",[103,107],{"name":99,"role":104,"phone":105,"phoneExt":59,"email":106},"CONTACT","34 91 36 8000","majecerro@yahoo.es",{"name":108,"role":104,"phone":109,"phoneExt":59,"email":110},"María Álvarez, MD","34 9 336 8000","mery1812@hotmail.com",[112,129,140,150,158,169,182],{"facility":113,"status":114,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"Hospital Quironsalud Madrid","RECRUITING","Pozuelo de Alarcón","Madrid","28223","Spain","ES",{"type":121,"coordinates":122},"Point",[123,124],-3.81338,40.43293,{"lat":124,"lon":123},[127],{"name":128,"role":104,"phone":59,"phoneExt":59,"email":59},"Fernando Cabañas",{"facility":130,"status":114,"city":131,"state":59,"zip":59,"country":118,"countryCode":119,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Complejo Hospitalario La Coruña","A Coruña",{"type":121,"coordinates":133},[134,135],-8.396,43.37135,{"lat":135,"lon":134},[138],{"name":139,"role":104,"phone":59,"phoneExt":59,"email":59},"Alejandro Dávila",{"facility":141,"status":114,"city":116,"state":59,"zip":59,"country":118,"countryCode":119,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Hospital Clínico San Carlos",{"type":121,"coordinates":143},[144,145],-3.70256,40.4165,{"lat":145,"lon":144},[148],{"name":149,"role":104,"phone":59,"phoneExt":59,"email":59},"Luis Arruza",{"facility":151,"status":114,"city":116,"state":59,"zip":59,"country":118,"countryCode":119,"cosmosGeoPoint":152,"geoPoint":154,"contacts":155},"Hospital Universitario La Paz",{"type":121,"coordinates":153},[144,145],{"lat":145,"lon":144},[156],{"name":157,"role":104,"phone":59,"phoneExt":59,"email":59},"Paloma Lopez",{"facility":159,"status":114,"city":160,"state":59,"zip":59,"country":118,"countryCode":119,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Hospital Universitario Carlos Haya","Málaga",{"type":121,"coordinates":162},[163,164],-4.42034,36.72016,{"lat":164,"lon":163},[167],{"name":168,"role":104,"phone":59,"phoneExt":59,"email":59},"Tomás Sánchez Tamayo",{"facility":170,"status":114,"city":171,"state":59,"zip":59,"country":118,"countryCode":119,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Hospital Vírgen del Rocío","Seville",{"type":121,"coordinates":173},[174,175],-5.97317,37.38283,{"lat":175,"lon":174},[178,180],{"name":179,"role":104,"phone":59,"phoneExt":59,"email":59},"Antonio Pavón Delgado",{"name":181,"role":101,"phone":59,"phoneExt":59,"email":59},"María José Moreno Valera",{"facility":183,"status":114,"city":184,"state":59,"zip":59,"country":118,"countryCode":119,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Hospital Universitario y Politécnico La Fe","Valencia",{"type":121,"coordinates":186},[187,188],-0.37966,39.47391,{"lat":188,"lon":187},[191],{"name":192,"role":104,"phone":59,"phoneExt":59,"email":59},"Máximo Vento",{"type":194,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR","100536851",false,"NCT06270199","Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.","Clinical Trial to Stablish the Security of Using Allogeneic Fetal Stem Mesenchymal Cells From Umbilical Cord, Expanded in Pre-term Patients Suffering of Bronchopulmonary Dysplasia.","Inclusion Criteria:\n\n* Alive newborns weighing ≤ 1250 grams and GA ≤ 28 weeks, who are on mechanical ventilation with a FiO2 ≥0.3 between days 5 and 14 of life, with no immediate extubation foreseeable.\n\nExclusion Criteria:\n\n* Presence of another concomitant congenital pathology at the time of inclusion: pulmonary malformations with compromised pulmonary function, active pulmonary haemorrhage, severe pulmonary hypoplasia, renal malformations with systemic compromise, congenital heart disease, polymalformative syndromes, chromosomopathies.\n* Presence of refractory haemodynamic instability of any cause at the time of inclusion.\n* Presence of severe neurological damage at the time of inclusion (HIV grade III or higher).\n* Patients who have required major surgery in the 72 hours prior to inclusion.\n* Patients who have necrotising enterocolitis (NEC) grades ≥II at the time of inclusion, according to the Bell classification.\n* Patients who are children of a mother with HIV","ALL","1 Month","28 Weeks",{"count":205,"type":206},75,"ESTIMATED","INTERVENTIONAL",[209],"PHASE2","Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients.",[212],"Bronchopulmonary Dysplasia",[214,215,216],"Bronchopulmonary dysplasia","Preterm newbnorn","Mesenchymal stem cells","2025-03-14",{"date":219,"type":220},"2025-03-17","ACTUAL",{"date":222,"type":220},"2024-01-11",{"date":224,"type":206},"2026-12",{"name":5,"class":6},7]