Status:
WITHDRAWN
Safety Study of Umbilical Cord Blood To Treat Pediatric Traumatic Brain Injury
Lead Sponsor:
Charles Cox
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-17 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
Traumatic brain injury is the primary cause of pediatric trauma related morbidity and mortality. Currently there is no reparative therapeutic option available, and all interventions are designed to pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01251003
Start Date
January 1 2011
End Date
May 1 2015
Last Update
December 10 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Texas Medical School at Houston, Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030