protocolSection identificationModule nctId: NCT06270199, orgStudyIdInfo id: PULMESCELL-2, briefTitle: Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-11, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Bronchopulmonary Dysplasia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Group Assignment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Control, interventions name: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions, interventions name: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions, outcomesModule primaryOutcomes measure: Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia, primaryOutcomes measure: feasibility variable, secondaryOutcomes measure: Incidence of BPD and PH in very low birth weight babies treated with MSC, secondaryOutcomes measure: Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen, secondaryOutcomes measure: Exitus on week 36 and 40 of post-menstrual age or at hospital discharge, secondaryOutcomes measure: Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death., secondaryOutcomes measure: 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)., secondaryOutcomes measure: Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy., secondaryOutcomes measure: Changes in modified respirator score during therapy and up to week 36 of port-menstrual age, secondaryOutcomes measure: Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age, secondaryOutcomes measure: Date of hospital discharge and respiratory care at discharge., secondaryOutcomes measure: Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2)., secondaryOutcomes measure: Duration of invasive and non-invasive mechanical ventilation., secondaryOutcomes measure: Use of postnatal corticosteroids indicated, secondaryOutcomes measure: Respiratory readmission rates., secondaryOutcomes measure: Bayley Neurodevelopmental Scale at 24 months, secondaryOutcomes measure: Date and cause of death., eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 28 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Complejo Hospitalario La Coruña, status: RECRUITING, city: La Coruña, country: Spain, contacts name: Alejandro Dávila, role: CONTACT, geoPoint lat: 43.37135, lon: -8.396, locations facility: Hospital Clínico San Carlos, status: RECRUITING, city: Madrid, country: Spain, contacts name: Luis Arruza, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario La Paz, status: RECRUITING, city: Madrid, country: Spain, contacts name: Paloma Lopez, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Carlos Haya, status: RECRUITING, city: Málaga, country: Spain, contacts name: Tomás Sánchez Tamayo, role: CONTACT, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Hospital Vírgen del Rocío, status: RECRUITING, city: Sevilla, country: Spain, contacts name: Antonio Pavón Delgado, role: CONTACT, contacts name: María José Moreno Valera, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Hospital Universitario y Politécnico La Fe, status: RECRUITING, city: Valencia, country: Spain, contacts name: Máximo Vento, role: CONTACT, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False