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Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy

Study acronym: SiSTEM-NEO
StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Sep 2026 to Sep 15, 2026v7
  2. Start date: Jun 2026 to Sep 2026v6
  3. Secondary endpoints revised (7)v5 See this version in full on ClinicalTrials.gov ↗
  4. Secondary endpoints: 6 to 7v4 See this version in full on ClinicalTrials.gov ↗
  5. Secondary endpoints: details revised at 3 of 6 entries Study description revisedv3 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  6. Completion date: Dec 2034 to Dec 2033 Interventions: 0.9 % Normal Saline (Drug), Wharton's jelly-derived mesenchymal stem cells (Drug) to 0.9 % Normal Saline (Drug), Wharton's jelly-derived mesenchymal stem cells (Biological) · Secondary endpoints: 3 to 6 · Study description expanded, about 504 words · 2 morev2 Show 5 more changesShow less
    • Interventions: 0.9 % Normal Saline (Drug), Wharton's jelly-derived mesenchymal stem cells (Drug) to 0.9 % Normal Saline (Drug), Wharton's jelly-derived mesenchymal stem cells (Biological)
    • Secondary endpoints: 3 to 6
    • Study description expanded, about 504 words
    • Study site revised
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Hypoxic-ischemic encephalopathy (HIE) is a serious condition in newborns caused by lack of oxygen and blood flow around the time of birth. Standard treatment with cooling therapy (therapeutic hypothermia) lowers the risk of death or disability, but many infants still suffer long-term problems. This study will test whether adding stem cell therapy after cooling can further improve outcomes. The stem cells are taken from donated human placentas (Wharton's jelly-derived mesenchymal stem cells, MSCs). The cells are prepared under strict laboratory standards and checked for safety. Infants with moderate to severe HIE who have completed cooling will be randomly assigned to receive either three intravenous infusions of MSCs or placebo within the first 10 days of life. Each infusion is given over about 30 minutes while the infant is closely monitored. Researchers will follow participants for up to 2 years. The main outcome is whether MSC treatment can reduce the combined risk of death or serious developmental delay at 1 year of age. The study will also track brain MRI findings, safety events, and developmental progress at 2 years.
Trial Details
NCT Number NCT07018739
Lead Sponsor Mahidol University
Collaborators: Siriraj Hospital
Conditions Hypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-Ischemic
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov