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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Use of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells
Use of Centricyte 1000 Closed System Digestion Autologous AD-tSVF to create AD-cSVF
Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use
Regenevita LLC
Stevensville, Montana, United States
Number of participants with adverse events
Activities of Daily Living (ADL)
Time frame: Outcome measures at baseline at 6 month
Cognitive Change in clinical symptoms associated with concussion-TBI
Montreal Cognitive Assessment Scale (MCAS)
Time frame: Outcome measures at baseline and reviewed 1 year interval for average time 5 years
Beck's Depression Inventory (BDI)
Multiple choice self reporting measure of depression
Time frame: Annual for 5 years
Adult Attention Deficit Assessment
Conner's Adult Attention Deficit Disorder Rate Scale (CAADDR)
Time frame: Annual for 5 years
MRI Brain With & MRI Brain With & Without Contrast
MRI Brain to evaluate progressive changes comparing pre-treatment (0), 3 year and 5 year status
Time frame: 0, 3 years, 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.