Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries (C-TBI)

Robert W. Alexander, MD, FICS

Status and phase: Withdrawn; Early Phase 1

Conditions: Concussion, Severe; Concussion, Intermediate; Traumatic Encephalopathies, Chronic; Concussion, Mild; Concussion, Brain

Treatments: Procedure: Microcannula Harvest Adipose; Procedure: Sterile Normal Saline IV deployment AD-cSVF; Device: Centricyte 1000

Study type: Interventional

Funder types: Industry

Identifiers

NCT02959294

RGV GARM 5

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 3 patient groups

Microcannula Harvest Adipose

Experimental group

Description:

Acquisition Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via close syringe microcannula harvest from subdermal fat deposits

Treatment:

Procedure: Microcannula Harvest Adipose

Centricyte 1000

Experimental group

Description:

Autologous AD-tSVF via enzymatic isolation/concentration via Centricyte 1000 Closed System to create AD-cSVF

Treatment:

Device: Centricyte 1000

Sterile Normal Saline

Experimental group

Description:

Re-suspension of AD-cSVF pellet in Normal Saline deployment via IV

Treatment:

Procedure: Sterile Normal Saline IV deployment AD-cSVF