- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593242
Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy
March 20, 2017 updated by: Michael Cotten
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own)umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy.
For this study, infants who have signs of moderate to severe encephalopathy at birth whose mothers have previously consented to providing cord blood cells for the Carolinas Cord Blood Bank or other public or private bank that uses accepted standards for collection and handling of cells, or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood cells if an adequate number of cells that meet Carolinas Cord Blood Bank Quality standards are available in the first 14 postnatal days.
Study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests.
Babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months at Duke's Special Infant Care Clinic.
MRI's will be obtained per clinical routine and results will be analyzed and described in study reports.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Mothers must have consented for cord blood collection at delivery
- cord blood must be available for extraction of stem cells.
- >34 weeks gestation
- cord or neonatal pH<7.0 or base deficit>16 milliequivalents per liter (mEq/L) or history of acute perinatal event
- either a 10 minute Apgar < 5 or continued need for ventilation.
- All infants must have signs of encephalopathy within 6 hours of age.
Exclusion Criteria:
- Inability to enroll by 14 days of age.
- Presence of known chromosomal anomaly.
- Presence of major congenital anomalies.
- Severe intrauterine growth restriction (weight <1800g)
- Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
- Parents refuse consent.
- Attending neonatologist refuses consent.
- Failure to collect the infant's cord blood and/or laboratory unable to process cord blood.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: infusions
infants who arrive at the study site within the first 14 postnatal days and had a history of moderate to severe hypoxic ischemic encephalopathy, and have cells available for infusion that pass Carolinas Cord Blood Bank Quality checks Outcomes will be measured at 22-26 months fby neurodevelopment assessment
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infants who meet study enrollment criteria for history of moderate to severe hypoxic ischemic encephalopathy in the neonatal period will receive up to 4 infusions of their own volume reduced cord blood cells.
The number of doses will be determined by the amount of available cord blood cells.
The dose for each infusion is 5x10e7 cells/kg
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Other: historical control
Infants who had moderate to severe hypoxic ischemic encephalopathy in the neonatal period but did not receive autologous cord blood cells.
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historical controls, no experimental intervention, standard therapies of hypoxic ischemic encephalopathy in the newborn period with autologous cord blood
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls.
Time Frame: during infusions: first 18 postnatal days
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during infusions: first 18 postnatal days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary endpoints of this pilot study will include preliminary efficacy as measured by neurodevelopmental function at 4 - 6 months and 9 - 12 months of age
Time Frame: 1 year
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1 year
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neuroimaging results will be collected and compared with available results from prior trials of therapies in this population, and from a previously collected set of images from normal term newborns through the first year of life.
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Escolar 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.
- Martin PL, Carter SL, Kernan NA, Sahdev I, Wall D, Pietryga D, Wagner JE, Kurtzberg J. Results of the cord blood transplantation study (COBLT): outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with lysosomal and peroxisomal storage diseases. Biol Blood Marrow Transplant. 2006 Feb;12(2):184-94. doi: 10.1016/j.bbmt.2005.09.016.
- Kurtzberg J, Lyerly AD, Sugarman J. Untying the Gordian knot: policies, practices, and ethical issues related to banking of umbilical cord blood. J Clin Invest. 2005 Oct;115(10):2592-7. doi: 10.1172/JCI26690.
- Staba SL, Escolar ML, Poe M, Kim Y, Martin PL, Szabolcs P, Allison-Thacker J, Wood S, Wenger DA, Rubinstein P, Hopwood JJ, Krivit W, Kurtzberg J. Cord-blood transplants from unrelated donors in patients with Hurler's syndrome. N Engl J Med. 2004 May 6;350(19):1960-9. doi: 10.1056/NEJMoa032613.
- McGraw P, Liang L, Escolar M, Mukundan S, Kurtzberg J, Provenzale JM. Krabbe disease treated with hematopoietic stem cell transplantation: serial assessment of anisotropy measurements--initial experience. Radiology. 2005 Jul;236(1):221-30. doi: 10.1148/radiol.2353040716.
- Cotten 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
January 2, 2008
First Submitted That Met QC Criteria
January 2, 2008
First Posted (Estimate)
January 14, 2008
Study Record Updates
Last Update Posted (Actual)
March 21, 2017
Last Update Submitted That Met QC Criteria
March 20, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00000412
- Duke NPRI01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neonatal Hypoxic Ischemic Encephalopathy
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Turku University HospitalNot yet recruitingNeonatal Stroke | Neonatal Hypoxic Ischemic Encephalopathy | Neonatal Encephalopathy, UnspecifiedFinland
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Neonatal Encephalopathy Consortium, JapanNational Cerebral and Cardiovascular Center; Nagoya University; Tokyo Women's... and other collaboratorsUnknownNeonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)Japan
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University of Wisconsin, MadisonMeriter FoundationRecruitingHypoxic-Ischemic Encephalopathy | Neonatal Encephalopathy | EncephalopathyUnited States
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Assiut UniversityUnknownNeonatal Hypoxic Ischemic Encephalopathy
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Assiut UniversityUnknownNeonatal Hypoxic Ischemic Encephalopathy
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University of California, San DiegoUniversity of Minnesota; Rady Children's Hospital, San Diego; Middlemore Hospital... and other collaboratorsRecruitingHypoxic-Ischemic Encephalopathy | Neonatal Encephalopathy | Neonatal Seizure | Seizure NewbornUnited States, New Zealand
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University Hospital, BordeauxCompletedNeonatal Hypoxic Ischemic EncephalopathyFrance
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Neonatal Encephalopathy Consortium, JapanNational Cerebral and Cardiovascular Center; Nagoya University; Tokyo Women's... and other collaboratorsCompletedNeonatal Encephalopathy | Hypoxic-ischemic EncephalopathyJapan
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Pharmazz, Inc.RecruitingHypoxic-Ischemic Encephalopathy | Neonatal Encephalopathy | Neonatal AsphyxiaIndia
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Clinical Trials on infusion of autologous cord blood
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Michael CottenThe Robertson FoundationCompletedModerate or Severe Hypoxic-ischemic Encephalopathy in NewbornsUnited States
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Pomeranian Medical University SzczecinUnknownNecrotizing Enterocolitis | Intracranial Hemorrhages | Retinopathy of Prematurity | Respiratory Distress Syndrome, Newborn | Anemia, Neonatal | Bronchopulmonary DysplasiaPoland
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yangjieCompletedSafety Issues | Neonatal Death | BPD - Bronchopulmonary DysplasiaChina
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Hospital Universitario Dr. Jose E. GonzalezUnknownMultiple Organ Failure | Hypoxia, Brain | Metabolic Acidosis | Apgar; 0-3 at 1 MinuteMexico
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Joanne Kurtzberg, MDAvailableCerebral Palsy | Apraxia of Speech | Hydrocephalus | Hypoxia Ischemia, Cerebral | Drowning; AnoxiaUnited States
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National University Hospital, SingaporeNational Medical Research Council (NMRC), SingaporeCompletedHypoxic Ischemic EncephalopathySingapore
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Charles CoxWithdrawnTraumatic Brain InjuryUnited States
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Joanne Kurtzberg, MDThe Marcus FoundationCompleted
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