Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
Concussion is the most common type of brain injury throughout life. Study is seeking
 improvement of long-term residua following adolescent and adult post-traumatic injuries often
 associated with contact sports and accidental causes. Typically defined as reversible head
 injury with temporary loss of brain function. Symptoms range from physical, cognitive, pain
 (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome. Use of
 AD-cSVF parenteral delivery to encourage repair of damage and decreased function following
 concussion, particularly in contact, repetitive sports injuries. Range of damage is measured
 in Grade I-III according to graduated severity. Unfortunately, less information is available
 about repetitive concussions and the long-term health issues.
Concussion Syndrome (CS) and TBI are common injuries producing temporary and long-term damage
 to impact brain function. Symptoms are sometimes transient, sometimes long-term depending on
 severity and/or repetitive damage. Signs varying from recurrent headaches, mental fog,
 emotional changes to physical signs of loss of consciousness, amnesia to behavioral change
 (irritability, loss of concentration ability, etc.), cognitive impairment (slow reaction
 times, memory loss), and recurring sleep disturbances.

 Common causes include sports injuries, automobile accidents, falls, blunt trauma to head, and
 explosive/blast injuries from production of acceleration injuries

 Treatment often involves monitoring, physical rest, limiting cognitive activities (such as
 computing, video games, texting, and studying). Most often a single episode usually resolve
 or improve (particularly in recurring headaches) within 3-4 weeks. It is estimated that
 >6/1000 occurrence rate apply. Repetitive injuries seem to make the person more susceptible
 to additional damage, particularly with injury precedes resolution of an earlier damage.
 There appears also to make persons to require a lesser impact to produce the same degree of
 severity. It is becoming more recognized that repeated concussions increase the risks in
 later life for dementia, Parkinson's and severe depressions.

 Most serious signs to evaluate are loss of consciousness, seizures, worsening headache,
 diplopia/pupil changes, loss of recognition, vomiting, focal neurological problems, and
 change of personality.

 There is no consensus definition of concussion or TBI. Most concussions are considered in the
 mild TBI (mTBI) group, and are rarely demonstrate structural brain damage when in the acute
 to subacute state. Late brain MRI changes are difficult to clearly point to or identify the
 specific areas of presumed damage.

 This study is intended to examine safety and efficacy of parenteral introduction of AD-cSVF
 in cases of CS and TBI, and categorically examine the outcomes according to the elapsed time
 from original concussive event. No delineation of those having recurrent damage and injuries
 are made within this study.
Inclusion Criteria:

 -  Documented history of mTBI or TBI with Correlated MRI or CT

 -  At least 1 month post mTBI and TBI

 -  Able and Willing to participate in CT or MRI pre-study and at 3 year, 5 year interval

 -  Able to provide informed consent to undergo the study

 -  Depression, Cognitive Disability, Attention Disorders, Headaches or other persistent
 changes which followed a traumatic brain event (TBI)

 -  Impaired social or occupational functioning following mTBI or TBI

 -  History of repetitive events for mTBI and TBI

 Exclusion Criteria:

 -  Documented history of neuro-degenerative illness, seizures, mental illness, or severe
 medical conditions preceding mTBI or TBI

 -  Malignances, Bleeding Disorders, Pregnancy or Lactation

 -  Tumors of Central Nervous System (CNS)

 -  Lack of adequate donor tissue volume as determined by the primary investigator at
 their discretion

 -  Any pre-existing medical condition which, in view of the primary investigator and
 patient's primary care physician, would prevent participation in study