Status:
COMPLETED
Safety of Autologous Stem Cell Treatment for Traumatic Brain Injury in Children
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
5-14 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if bone marrow progenitor cell (BMPC) autologous transplantation in children after isolated traumatic brain injury is safe and will improve functional outcome...
Detailed Description
Traumatic brain injury (TBI) contributes to 50% of all trauma deaths. The mortality rate for children following severe TBI (Glasgow Coma Scale \< 9) ranges from 14-24%. There is currently no therapy t...
Eligibility Criteria
Inclusion
- Between 5 and 14 years of age on the day of injury
- Hospital admission Glasgow coma score between 5 and 8
- Initial injury occurring less than 24 hours prior to consent
Exclusion
- Known history of:
- Previous brain injury
- Developmental delay
- Neurologic impairment and/or deficit
- Seizure disorder requiring anti-convulsant therapy
- Renal disease or altered renal function as defined by serum creatinine \> 1.5 mg/dL at admission
- Hepatic disease or altered liver function as defined by SGPT \> 150 U/L, and/or T. bilirubin \> 1.3 mg/dL at admission
- Cancer
- Immunosuppression as defined by WBC \< 3 (10x3) at admission
- HIV
- Obliteration of perimesencephalic cistern on initial head CT/MRI suggesting prolonged hypoxic ischemic insult
- Initial hospital ICP \> 40
- Hemodynamic instability at the time of consent defined as ongoing fluid resuscitation and/or requirement for inotropic support to maintain MAP at or above normals for age - does not include CPP based inotropic support
- Uncorrected coagulopathy at the time of consent defined as INR \> 1.4; PTT \> 35 sec; PLT \< 100,000; fibrinogen \< 100 g/dL
- Unstable pelvic fractures defined as requiring operative fixation to manage
- Pulmonary contusions defined as a chest x-ray with non-anatomic opacification and/or PaO2:FIO2 ratio \< 250 associated with the mechanism or injury
- Solid or hollow visceral injury of the abdomen and/or pelvis as diagnosed by CT or other imaging
- Spinal cord injury as diagnosed by CT or MR imaging or by clinical findings.
- Persistent hypoxia defined as SaO2 \< 94% for \> 30 minutes occurring at any time from hospital admission to time of consent
- Positive urine pregnancy test
- Participation in an intervention study
- Unwillingness to return for follow-up visits
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00254722
Start Date
April 1 2006
End Date
October 1 2009
Last Update
May 13 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.