Cerro Marín, Maria Jesús delMoreno Gutiérrez, LauraVento Torres, Máximo2026-01-152026-01-152024-06Cerro Marín MJD, Ormazábal IG, Gimeno-Navarro A, Álvarez-Fuente M, López-Ortego P, Avila-Alvarez A, Arruza Gómez L, González-Menchen C, Labrandero de Lera C, Lozano Balseiro M, Moreno Gutiérrez L, Melen Frajilich G, Ramírez Orellana M, Saldaña García N, Pavón Delgado A, Vento Torres M; “PULMESCELL” investigators. Repeated intravenous doses of human umbilical cord-derived mesenchymal stromal cells for bronchopulmonary dysplasia: results of a phase 1 clinical trial with 2-year follow-up. Cytotherapy. 2024 Jun;26(6):632-640. doi: 10.1016/j.jcyt.2024.02.028. Epub 2024 Mar 11. PMID: 38556960.1465-324910.1016/j.jcyt.2024.02.028https://hdl.handle.net/20.500.14352/130276Background: Currently, there is a lack of effective treatments or preventive strategies for bronchopulmonary dysplasia (BPD). Pre-clinical studies with mesenchymal stromal cells (MSCs) have yielded encouraging results. The safety of administering repeated intravenous doses of umbilical cord tissue-derived mesenchymal stromal cells (UC-MSCs) has not yet been tested in extremely-low-gestational-age newborns (ELGANs). Aims: to test the safety and feasibility of administering three sequential intravenous doses of UC-MSCs every 7 days to ELGANs at risk of developing BPD. Methods: In this phase 1 clinical trial, we recruited ELGANs (birth weight ≤1250 g and ≤28 weeks in gestational age [GA]) who were on invasive mechanical ventilation (IMV) with FiO2 ≥ 0.3 at postnatal days 7-14. Three doses of 5 × 106/kg of UC-MSCs were intravenously administered at weekly intervals. Adverse effects and prematurity-related morbidities were recorded. Results: From April 2019 to July 2020, 10 patients were recruited with a mean GA of 25.2 ± 0.8 weeks and a mean birth weight of 659.8 ± 153.8 g. All patients received three intravenous UC-MSC doses. The first dose was administered at a mean of 16.6 ± 2.9 postnatal days. All patients were diagnosed with BPD. All patients were discharged from the hospital. No deaths or any serious adverse events related to the infusion of UC-MSCs were observed during administration, hospital stays or at 2-year follow-up. Conclusions: The administration of repeated intravenous infusion of UC-MSCs in ELGANs at a high risk of developing BPD was feasible and safe in the short- and mid-term follow-up.engAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/journal articlehttps://doi.org/10.1016/j.jcyt.2024.02.02838556960https://www.sciencedirect.com/science/article/pii/S1465324924000896?via%3Dihubhttps://pubmed.ncbi.nlm.nih.gov/38556960/open accessDisplasia broncopulmonarRecién nacidos extremadamente prematurosCélulas madre mesenquimalesPediatríaFarmacología (Farmacia)3209.03 Evaluación de Medicamentos3201.10 Pediatría