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Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety.
This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.
Details
| Lead sponsor | Michael Cotten |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 52 |
| Start date | 2008-01 |
| Completion | 2017-01 |
Conditions
- Neonatal Hypoxic Ischemic Encephalopathy
Interventions
- infusion of autologous cord blood
- Neurodevelopmental outcomes
Primary outcomes
- Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. — during infusions: first 18 postnatal days
Countries
United States