Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy
Starting soon · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Hypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-Ischemic
In brief
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.
Key facts
- Study ID
- NCT07018739
- Run by
- Mahidol University
- People needed
- 40
- Starts
- 2026-06-01
- Expected to finish
- 2033-12-01
- Last updated by the study team
- 2026-07-07
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Term and late-preterm infants (gestational age ≥34 weeks)
- Diagnosed with moderate to severe HIE based on modified Sarnat staging
- Received TH per standard protocol
- Parental consent obtained
You may not qualify if…
- Major congenital anomalies or genetic syndromes
- Severe sepsis or active infection
- Severe coagulopathy or bleeding disorders
- Multi-organ failure
Where it is running
- Siriraj Hospital, Mahidol University — Bangkok, Thailand
Full record on ClinicalTrials.gov
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