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iSTOP-CP intranasal remestemcel for neonatal hypoxic-ischemic brain injury
NL-OMON61332Phase 2Not yet recruiting
- Sponsor
- University Medical Center Utrecht
- Start
- Oct 2026
- Modality
- Mesenchymal Stem Cells → Adult Stem Cells → Stem Cell Therapies → Cell Therapies
- Countries
- 1
01
Overview
Phase 2, randomised trial in hypoxic-ischemic encephalopathy (HIE), asphyxia neonatorum and perinatal arterial ischemic stroke (PAIS) comparing Intranasal remestemcel with Placebo (2 arms). Primary endpoint: Bayley-IV-NL motor score at 24 months. Planned start Oct 2026; status: not yet recruiting.
02
Drugs
Provacel
03
Conditions
hypoxic-ischemic encephalopathy (HIE)asphyxia neonatorumperinatal arterial ischemic stroke (PAIS)
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