Autologous Cord Blood Cells for Brain Injury in Term Newborns
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| First Received Date ICMJE | July 23, 2012 | ||||||||||||
| Last Updated Date | July 24, 2012 | ||||||||||||
| Start Date ICMJE | September 2011 | ||||||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Safety [ Time Frame: 1-3 days of age ] [ Designated as safety issue: Yes ] Adverse event rates occurring in the recipients |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01649648 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Autologous Cord Blood Cells for Brain Injury in Term Newborns | ||||||||||||
| Official Title ICMJE | Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety | ||||||||||||
| Brief Summary | This is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury. The cord blood used is fresh (not frozen and then thawed). |
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| 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 and have cord blood collected at birth can receive their own cord blood cells during the 3 days of age. Babies will be followed for neurodevelopmental outcome at 1, 4 - 6, 9 - 12 months and 18-24 months. MRI brain will be obtained at 1-2 weeks and 4-6 months old. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 1 | ||||||||||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Hypoxic Ischemic Encephalopathy | ||||||||||||
| Intervention ICMJE | Biological: Autologous cord blood
Baby's own umbilical cord blood |
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| Study Arm (s) | Experimental: Intervention
Autologous cord blood cells arm
Intervention: Biological: Autologous cord blood |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||||||
| Estimated Completion Date | September 2015 | ||||||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | up to 3 Days | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Singapore | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01649648 | ||||||||||||
| Other Study ID Numbers ICMJE | NMRC/EDG/1032/2, EDG09nov061 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | National University Hospital, Singapore | ||||||||||||
| Study Sponsor ICMJE | National University Hospital, Singapore | ||||||||||||
| Collaborators ICMJE | National Medical Research Council (NMRC), Singapore | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | National University Hospital, Singapore | ||||||||||||
| Verification Date | April 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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