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

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 mesen...

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Published in:Cytotherapy (Oxford, England) England), 2024-06, Vol.26 (6), p.632-640
Main Authors: Cerro Marín, Maria Jesús del, Ormazábal, Itziar Garcia, Gimeno-Navarro, Ana, Álvarez-Fuente, María, López-Ortego, Paloma, Avila-Alvarez, Alejandro, Arruza Gómez, Luis, González-Menchen, Cristina, Labrandero de Lera, Carlos, Lozano Balseiro, María, Moreno Gutiérrez, Laura, Melen Frajilich, Gustavo, Ramírez Orellana, Manuel, Saldaña García, Natalia, Pavón Delgado, Antonio, Vento Torres, Máximo
Format: Article
Language:English
Subjects:
Administration, Intravenous
bronchopulmonary dysplasia
Bronchopulmonary Dysplasia - therapy
extremely low gestational age newborn
Female
Follow-Up Studies
Gestational Age
human umbilical cord tissue-derived mesenchymal stromal cells
Humans
Infant, Newborn
Infant, Premature
Male
Mesenchymal Stem Cell Transplantation - methods
Mesenchymal Stem Cells - cytology
phase 1 clinical trial
serious adverse events
Umbilical Cord - cytology
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Summary: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). 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. 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. 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.
ISSN:1465-3249
1477-2566
1477-2566
DOI:10.1016/j.jcyt.2024.02.028