Study of hCT-MSC in Newborn Infants With Moderate or Severe HIE
Moderate to Severe Hypoxic-ischemic Encephalopathy
About this trial
This is an interventional treatment trial for Moderate to Severe Hypoxic-ischemic Encephalopathy focused on measuring hypoxic-ischemic encephalopathy, newborn infants, therapeutic hypothermia, hCT-MSC, an Umbilical Cord Tissue-Derived Mesenchymal Stromal Cell Product
Eligibility Criteria
Inclusion Criteria:
- 36 0/7th weeks gestation or older at the time of delivery.
- Able to receive one dose of hCT-MSCs in the first 48 postnatal hours
- Willingness to return for one year assessments.
- Signs of encephalopathy within 6 hours of age
Exclusion Criteria:
- Major congenital or chromosomal abnormalities
- Severe growth restriction (birth weight <1800 g)
- Opinion by attending neonatologist that the study may interfere with clinical treatment or safety of subject
- Moribund neonates for whom no further treatment is planned
- Infants whose mothers have unknown serologies for Hepatitis B or HIV
- Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have active syphilis or CMV infection in pregnancy
- Infants suspected of overwhelming sepsis
- ECMO initiated or likely in the first 48 hours of life
- Mother suspected to have intraamniotic infection at time of birth.
- ALL blood gases (cord and postnatal) done within the first 60 minutes had a pH > 7.15 AND base deficit < 10 mEq/L (source can be arterial, venous or capillary)
- Mother with documented Zika infection during this pregnancy
- Availability of autologous cord blood collected and usable in the randomized trial of autologous volume- and red blood cell-reduced cord blood cells (Duke IRB Pro00066647; clinical trials.gov link: https://clinicaltrials.gov/ct2/show/NCT02612155 )
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
First cohort of 3 subjects enrolled
Second cohort of 3 subjects enrolled
The first cohort of three patients will receive a single dose in the first 48 postnatal hours.
If there are no safety concerns after the first cohort of 3 subjects are infused then the second cohort of three patients will receive two doses, with the first dose given in the first 48 postnatal hours and the second dose given approximately two months after the first dose.