Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries (C-TBI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02959294|
Recruitment Status : Enrolling by invitation
First Posted : November 9, 2016
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Encephalopathies, Chronic Concussion, Mild Concussion, Intermediate Concussion, Severe Concussion, Brain||Procedure: Microcannula Harvest Adipose Device: Centricyte 1000 Procedure: Sterile Normal Saline IV deployment AD-cSVF||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Adipose-Derived Cellular Stromal Vascular Fraction (AD-cSVF) Parenterally in Post-Concussion Injuries and Traumatic Brain Injuries (TBI)|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||March 2024|
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 IV deployment AD-cSVF
Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use
- Number of participants with adverse events [ Time Frame: Outcome measures at baseline at 6 month ]Activities of Daily Living (ADL)
- Cognitive Change in clinical symptoms associated with concussion-TBI [ Time Frame: Outcome measures at baseline and reviewed 1 year interval for average time 5 years ]Montreal Cognitive Assessment Scale (MCAS)
- Beck's Depression Inventory (BDI) [ Time Frame: Annual for 5 years ]Multiple choice self reporting measure of depression
- Adult Attention Deficit Assessment [ Time Frame: Annual for 5 years ]Conner's Adult Attention Deficit Disorder Rate Scale (CAADDR)
- MRI Brain With & MRI Brain With & Without Contrast [ Time Frame: 0, 3 years, 5 years ]MRI Brain to evaluate progressive changes comparing pre-treatment (0), 3 year and 5 year status
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959294
|United States, Montana|
|Stevensville, Montana, United States, 59870|
|Principal Investigator:||Robert W. Alexander, MD||GARM International and GARM USA|
|Principal Investigator:||Glenn C Terry, MD||GARM|