Safety Study of Umbilical Cord Blood To Treat Pediatric Traumatic Brain Injury
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Traumatic Brain Injury
In brief
The purpose of this study is to determine if it is safe to use stored autologous Human Umbilical Cord Blood (hUCB) to treat pediatric patients that sustain a severe or moderate Traumatic Brain Injury (TBI), and have not fully recovered as measured by the Glasgow Outcome Score-Expanded (GOS-EC)/Child at 6 to 18 months post-injury.
Key facts
- Study ID
- NCT01251003
- Run by
- Charles Cox
- People needed
- 0
- Starts
- 2011-01-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2015-12-10
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Hospital admission Glasgow Coma Score between 3 and 12 at the time of injury
- Injury occurring 6 to 18 months prior to study cord blood infusion (+/- 30 days)
- Ability of child and caregiver to travel to Houston, and stay for at least 4 days, and to return for all Follow-up visits
- Ability of child to understand (and speak) English
- Child's own cord blood banked at Cord Blood Registry
You may not qualify if…
- Inability to obtain all pertinent medical records, including pertinent physician notes, laboratory findings, and radiographic images, related to the original injury, hospitalization and rehabilitation
- Recent radiographic evidence of extensive stroke as evidenced by >100ml lesion
- Pre-injury history of seizure disorder and/or neurological impairment
- Obliteration of perimesencephalic cistern on initial head CT/MRI
- Initial hospital Intracranial Pressure (ICP) > 40
- Unhealed fractures or wounds including osteomyelitis
- Pneumonia, or chronic lung disease requiring oxygen
- Spinal cord injury as diagnosed by CT or MR imaging or by clinical findings
- Cord blood sample contamination
- Participation in a concurrent intervention study
Where it is running
- The University of Texas Medical School at Houston, Children's Memorial Hermann Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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