Safety of Autologous Stem Cell Treatment for Traumatic Brain Injury in Children

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston

Criteria

Inclusion Criteria:

1. Between 5 and 14 years of age on the day of injury

2. Hospital admission Glasgow coma score between 5 and 8

3. Initial injury occurring less than 24 hours prior to consent

Exclusion Criteria:

1. 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

2. Obliteration of perimesencephalic cistern on initial head CT/MRI suggesting prolonged hypoxic ischemic insult

3. Initial hospital ICP > 40

4. 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

5. Uncorrected coagulopathy at the time of consent defined as INR > 1.4; PTT > 35 sec; PLT < 100,000; fibrinogen < 100 g/dL

6. Unstable pelvic fractures defined as requiring operative fixation to manage

7. Pulmonary contusions defined as a chest x-ray with non-anatomic opacification and/or PaO2:FIO2 ratio < 250 associated with the mechanism or injury

8. Solid or hollow visceral injury of the abdomen and/or pelvis as diagnosed by CT or other imaging

9. Spinal cord injury as diagnosed by CT or MR imaging or by clinical findings.

10. Persistent hypoxia defined as SaO2 < 94% for > 30 minutes occurring at any time from hospital admission to time of consent

11. Positive urine pregnancy test

12. Participation in an intervention study

13. Unwillingness to return for follow-up visits