Treatment of Adult Severe Traumatic Brain Injury Using Autologous Bone Marrow Mononuclear Cells
Abstract
Traumatic brain injury (TBI) contributes to 50% of all trauma deaths. The mortality rate for adults following severe TBI (Glasgow Coma Scale < 9) is estimated to be 33%. There is currently no therapy to reverse the primary injury associated with TBI. Over the past 10 years there has been a growing body of literature supporting the use of various progenitor cell types to treat acute neurological injuries such as TBI. Our primary hypothesis is that bone marrow mononuclear cell (BMMNC) autologous transplantation after TBI is safe (harvest and infusion related toxicity) after TBI. Our secondary hypothesis is that functional outcomes measures will improve after BMMNC infusion, (3) BMMNC infusion will reduce BBB permeability, and (4) BMMNC is neuroprotective and preserves grey matter and white matter volumes after TBI. Patients, ages18 to 55 years old, admitted to Memorial Hermann Hospital Trauma Center with Glasgow Coma Scores (GCS) of 5 to 8 are screened. This is a dose-escalation study consisting of 4 cohorts including a control group (5 subjects/cohort). The first five subjects will not undergo the bone marrow harvest procedure; though they will be followed and treated the same as the other study participants and complete all follow-up procedures. Subjects are followed for safety, have plasma and CSF (if available) collected for neuroinflammatory markers, and at 30-days and 6 months post-injury, neuropsych and functional outcomes testing and DTMRI are performed. To date, 12 subjects have been enrolled (all controls) and have had plasma collected for neuroinflammatory markers and have returned for their 30-day follow-up visits. 6 subjects have completed their 6 month follow-up assessments.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jun 01, 2013
- Accession Number
- ADA584217
Entities
People
- Charles S. Cox Jr.
Organizations
- University of Texas Health Science Center at Houston