Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
Keywords
Abstract
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.
Dates
| Last Verified: | 12/31/2019 |
| First Submitted: | 11/06/2016 |
| Estimated Enrollment Submitted: | 11/06/2016 |
| First Posted: | 11/08/2016 |
| Last Update Submitted: | 01/18/2020 |
| Last Update Posted: | 01/21/2020 |
| Actual Study Start Date: | 10/31/2016 |
| Estimated Primary Completion Date: | 10/31/2023 |
| Estimated Study Completion Date: | 02/29/2024 |
Condition or disease
Intervention/treatment
Procedure: Microcannula Harvest Adipose
Device: Centricyte 1000
Procedure: Sterile Normal Saline
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Microcannula Harvest Adipose Acquisition Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via close syringe microcannula harvest from subdermal fat deposits | Procedure: Microcannula Harvest Adipose Use of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells |
| Experimental: Centricyte 1000 Autologous AD-tSVF via enzymatic isolation/concentration via Centricyte 1000 Closed System to create AD-cSVF | Device: Centricyte 1000 Use of Centricyte 1000 Closed System Digestion Autologous AD-tSVF to create AD-cSVF |
| Experimental: Sterile Normal Saline Re-suspension of AD-cSVF pellet in Normal Saline deployment via IV | Procedure: Sterile Normal Saline Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use |
Eligibility Criteria
| Ages Eligible for Study | 16 Years To 16 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Number of participants with adverse events [Outcome measures at baseline at 6 month]
2. Cognitive Change in clinical symptoms associated with concussion-TBI [Outcome measures at baseline and reviewed 1 year interval for average time 5 years]
Secondary Outcome Measures
1. Beck's Depression Inventory (BDI) [Annual for 5 years]
2. Adult Attention Deficit Assessment [Annual for 5 years]
3. MRI Brain With & MRI Brain With & Without Contrast [0, 3 years, 5 years]
