Clinical trial
A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)
Name
Pro00066647
Description
This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.
Trial arms
Trial start
2017-03-30
Estimated PCD
2019-08-05
Trial end
2019-08-05
Status
Completed
Phase
Early phase I
Treatment
Infusion of autologous cord blood
Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.
Arms:
Intervention cell recipients
Placebo
Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.
Arms:
Placebo recipients
Size
35
Primary endpoint
Survival at One Year
1 year
Number of Participants With Bayley III Scores in All Three Domains > or Equal to 85
1 year
Eligibility criteria
Inclusion Criteria:
1. NICHD Neonatal Research Network Hypothermia Trial inclusion criteria
2. Mothers must have consented or given verbal assent for cord blood collection at delivery, and cord blood must be available for volume and red blood cell reduction before 45 hours of age
3. The infant must be able to receive at least one dose of autologous cord blood before 48 hours of age
4. All infants must have signs of encephalopathy within 6 hours of age
Exclusion Criteria:
1. Major congenital or chromosomal abnormalities
2. Severe growth restriction (birth weight \<1800 g)
3. Opinion by attending neonatologist that the study may interfere with treatment or safety of subject
4. Moribund neonates for whom no further treatment is planned
5. Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have active syphilis or CMV infection in pregnancy
6. Infants suspected of overwhelming sepsis
7. ECMO initiated or likely in the first 48 hours of life
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 35, 'type': 'ACTUAL'}}
Updated at
2024-05-16
1 organization
2 products
1 indication
Organization
Michael CottenProduct
Placebo