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