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. 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. 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 and white matter volumes after TBI. This is a dose-escalation study consisting of 4 cohorts including a control group. The 1st five subjects in the treatment group will receive the lowest dose target of 6x106 mononuclear cells/kilogram body weight. The next five subjects will receive 9x106 mononuclear cells/kilogram body weight, and the last five subjects in the treatment group will receive 12x106 mononuclear cells/kilogram body weight. The 10 subjects in the control group 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. All subjects (including those in the control group), will be followed for safety, have plasma & CSF (if available) collected for neuroinflammatory markers.
Document Details
- Document Type
- Technical Report
- Publication Date
- Dec 01, 2014
- Accession Number
- ADA619276
Entities
People
- Charles S. Cox Jr.
Organizations
- University of Texas Health Science Center at Houston