Evidence · Randomised trial
A Pilot Phase I Trial of Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells in Neonates With Hypoxic-Ischemic Encephalopathy.
- Hypoxic-ischaemic encephalopathy and cooling
- Medical
- Neurodevelopmental follow-up
- Neurology
Summary
Pilot phase I trial testing safety and preliminary efficacy of intravenous allogeneic umbilical cord tissue-derived mesenchymal stromal cells in neonates with moderate to severe hypoxic-ischaemic encephalopathy receiving therapeutic hypothermia. Six infants were randomised to one or two doses, the first given during cooling and the second two months later. Infusions were well tolerated, though most infants developed low-titre anti-HLA antibodies; all survived with average to low-average developmental scores at 12-17 months. The authors conclude further study is warranted.
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- Open (Creative Commons)
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