drugset / Trial / NCT03857841
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
RandomizedSequentialQuadruple-blindTreatment
Summary
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at \<27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
Timeline
- Start
- 2019-10-09
- Primary completion
- 2021-05-20
- Completion
- 2021-05-20
Outcome
Outcome not reported
Stopped (Business): “The study was discontinued due to a business decision; no safety concerns were noted.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UNEX-42 | Other / unclassified | 20 unknown | Intravenous |
| Subject | UNEX-42 | Other / unclassified | 60 unknown | Intravenous |
| Subject | UNEX-42 | Other / unclassified | 200 unknown | Intravenous |