Clinical trial NCT02959294: Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
Official title: Use of Adipose-Derived Cellular Stromal Vascular Fraction (AD-cSVF) Parenterally in Post-Concussion Injuries and Traumatic Brain Injuries (TBI)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Traumatic Encephalopathies, Chronic
Concussion, Mild
Concussion, Intermediate
Concussion, Severe
Concussion, Brain
Keywords: TBI
mTBI
Concussion, Brain
Loss Consciousness, Traumatic
Headaches
Lead sponsor: Healeon Medical Inc
Sponsor class: INDUSTRY
First posted: 2016-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Outcome measures at baseline at 6 month
measure: Cognitive Change in clinical symptoms associated with concussion-TBI
timeFrame: Outcome measures at baseline and reviewed 1 year interval for average time 5 years
Secondary outcomes:
measure: Beck's Depression Inventory (BDI)
timeFrame: Annual for 5 years
measure: Adult Attention Deficit Assessment
timeFrame: Annual for 5 years
measure: MRI Brain With & MRI Brain With & Without Contrast
timeFrame: 0, 3 years, 5 years
Other outcomes:
Locations:
city: Stevensville
country: United States
facility: Regenevita LLC
state: Montana
Study officials:
affiliation: GARM International and GARM USA
name: Robert W. Alexander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GARM
name: Glenn C Terry, MD
role: PRINCIPAL_INVESTIGATOR
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