| Study name |
Autologous cord blood and human placental derived stem cells in neonates with severe hypoxic‐ischemic encephalopathy (HPDSC+HIE) |
| Methods |
Phase 2 open‐label interventional study |
| Participants |
Sample population: 20
Inclusion criteria
Gestational age ≥ 36 weeks Birth weight ≥ 1800 grams Postnatal age after birth of less than 6 hours Autologous cord blood and HPDSCs available for infusion Plus 1 or more of the following criteria: Apgar ≤ 5 at 10 minutes of postnatal age, or Continued need for resuscitation ≥ 10 min after birth, or Acidosis‐cord blood pH or arterial blood pH within 60 minutes of birth ≤ 7.0 pH, or Base deficit ≥ minus 16 mEq in cord blood and within 60 min of birth. Plus Moderate to Severe Altered State of Consciousness, by 1 or more of the following: Hypotonia, or Abnormal reflexes, or Absent/weak suck.
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| Interventions |
Autologous HPDSC collected after birth will be infused in aliquots. one‐half of the HPDSC infused on Day 2; one‐half of the collected HPDSC will be infused on Day 8. Autologous Cord Blood collected after birth will be infused in aliquots. One‐third of the collected cord blood will be infused within the first 24 hours after birth (Day 0); one‐third of the collected cord blood will be infused on day 3; and one‐third of the collected cord blood unit will be infused on Day 7. |
| Outcomes |
Primary: number of subjects with infusion reaction as a measure of safety and tolerability within the first 30 days
Secondary: improvement in neurological condition 2 years post HPDSC infusion as shown on head MRI, DTI and neurological development by Sarnat testing. |
| Starting date |
June 2019 |
| Contact information |
Principal Investigator: Mitchell S Cairo, MD; New York Medical College |
| Notes |
Study sponsor: New York Medical College |
