Clinical trial · Interventional
A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy
A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)
NCT02612155CI-TRIAL-00077225(HIE)completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infusion of autologous cord blood | Biological | — | UNRESOLVED |
| Placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention cell recipients
- description
- Experimental: infusions: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have autologous nucleated cord blood cells available for infusion will receive up to two infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment
- interventionNames
- Biological: Infusion of autologous cord blood
- type
- PLACEBO_COMPARATOR
- label
- Placebo recipients
- description
- Control: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have cord blood available for infusion will receive placebo (a mix of autologous cord blood red blood cells and plasma) infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment
- interventionNames
- Biological: Placebo
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Hours
- Maximum age
- 6 Hours
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDCotten CM, Murtha AP, Goldberg RN, Grotegut CA, Smith PB, Goldstein RF, Fisher KA, Gustafson KE, Waters-Pick B, Swamy GK, Rattray B, Tan S, Kurtzberg J. Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy. J Pediatr. 2014 May;164(5):973-979.e1. doi: 10.1016/j.jpeds.2013.11.036. Epub 2013 Dec 31. PMID 24388332
- BACKGROUNDShankaran S, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, Fanaroff AA, Poole WK, Wright LL, Higgins RD, Finer NN, Carlo WA, Duara S, Oh W, Cotten CM, Stevenson DK, Stoll BJ, Lemons JA, Guillet R, Jobe AH; National Institute of Child Health and Human Development Neonatal Research Network. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med. 2005 Oct 13;353(15):1574-84. doi: 10.1056/NEJMcps050929. PMID 16221780
- BACKGROUNDEscolar ML, Poe MD, Provenzale JM, Richards KC, Allison J, Wood S, Wenger DA, Pietryga D, Wall D, Champagne M, Morse R, Krivit W, Kurtzberg J. Transplantation of umbilical-cord blood in babies with infantile Krabbe's disease. N Engl J Med. 2005 May 19;352(20):2069-81. doi: 10.1056/NEJMoa042604. PMID 15901860