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Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells

Study acronym: NEOSTEM
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Apr 2025 to Apr 2028 Completion date: Sep 2025 to Sep 2028v3 Show 1 more changeShow less
    • Completion date: Sep 2025 to Sep 2028
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Apr 2020 to Apr 2025 · Start date: Apr 2017 to Feb 5, 2020 · Completion date: Sep 2020 to Sep 2025 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Apr 2020 to Apr 2025
    • Start date: Apr 2017 to Feb 5, 2020
    • Completion date: Sep 2020 to Sep 2025
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss. Currently, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions. Cord blood stem cells are a promising treatment for the near future. The primary objective of this study is to test the safety and feasibility of a curative treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy. The secondary objectives are to test the efficacy of this curative treatment with cell with neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum timing of cell preparation administration
Trial Details
NCT Number NCT02881970
Lead Sponsor Assistance Publique Hopitaux De Marseille
Conditions Neonatal Hypoxic-ischaemic Encephalopathy
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov