Condition: Bronchopulmonary Dysplasia · Sponsor: EXO Biologics S.A.
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in extremely premature neonates. The study population includes babies born between 23 and 28 (27 + 6 days) weeks of gestational age and body weight between 500g and 1,500 g. Thirty-six subjects will receive one or three administrations of the three doses of EXOB-001 via the endotracheal route in phase 1. In phase 2, two dosages based on the results of phase 1 will be selected and a total of 203 subjects will be randomised to receive either EXOB-001 or placebo (saline solution). Infants will be followed up to 2 years of corrected age (end of study).
This description comes directly from the study's public registry record.
Beatrice De Vos, M.D., Ph.D. · +32 478 88 26 57 · b.devos@exobio.be
Lorine Preud'homme, M.Sc. · +32 468 07 40 71 · l.preudhomme@exobio.be
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| Cliniques Universitaires Saint-Luc (UCLouvain) | Brussels, Belgium | Not Yet Recruiting |
| ISPPC CHU Charleroi | Charleroi, Belgium | Not Yet Recruiting |
| Clinique CHC Montlégia | Liège, Belgium | Not Yet Recruiting |
| AOU Careggi | Florence, Italy | Active Not Recruiting |
| IRCCS Instituto Giannina Gaslini | Genova, Italy | Recruiting |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan, Italy | Active Not Recruiting |
| AOU Policlinico di Modena | Modena, Italy | Not Yet Recruiting |
| Unità di Fase I della UOC Terapia Intensiva e Patologia Neonatale, Assistenza Neonatale (TINI) dell'Azienda Ospedale Università di Padova | Padua, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06279741