Traumatic Brain Injury Clinical Study Information

Today, we understand a great deal more about the healthy brain and its response to trauma, although science still has much to learn about how to reverse damage resulting from head injuries.

TBI costs the country more than $56 billion a year, and more than 5 million Americans alive today have had a TBI resulting in a permanent need for help in performing daily activities. Survivors of TBI are often left with significant cognitive, behavioral, and communicative disabilities, and some patients develop long-term medical complications, such as epilepsy.

“Our work with TBI patients is some of the most important that we do.  Our brave men and women in the military deserve the very best.” – Dr. Dipnarine Maharaj M.D.

Other statistics dramatically tell the story of head injury in the United States. Each year:

  • approximately 1.4 million people experience a      TBI,
  • approximately 50,000 people die from head injury,
  • approximately 1 million head-injured people      are treated in hospital emergency rooms, and
  • approximately 230,000 people are hospitalized      for TBI and survive.
Study/Product Aim

The   principal objective of this research program is to test the use of Granulocyte   Colony Stimulating Factor, a stimulator of pluripotent stem cell production,   for the recovery of function of individuals with treatment refractory   moderate-severe TBI. Complete characterization of physiological and   psychological measures (with INAS) and immunological measures will occur.

Approach

Veterans   from S. Florida with treatment refractory TBI will be recruited for G-CSF   treatment.  Physiological,   psychological, and immunological characterization will be compiled at pre-   and post-G-CSF treatment, and at 3, 6, and 12 months following.  Multivariate repeated measures statistics   will be applied to clinical measures. Integrated analysis using random forest   classifier will be used to compile all acquired data sets.

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