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

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ClinicalTrials.gov Identifier: NCT02959294
Recruitment Status : Withdrawn (COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform]])
First Posted : November 9, 2016
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Robert W. Alexander, MD, FICS, Healeon Medical Inc

Study Description
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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.

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 Early Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Adipose-Derived Cellular Stromal Vascular Fraction (AD-cSVF) Parenterally in Post-Concussion Injuries and Traumatic Brain Injuries (TBI)
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 IV deployment AD-cSVF
Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Outcome measures at baseline at 6 month ]
    Activities of Daily Living (ADL)

  2. 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)


Secondary Outcome Measures :
  1. Beck's Depression Inventory (BDI) [ Time Frame: Annual for 5 years ]
    Multiple choice self reporting measure of depression

  2. Adult Attention Deficit Assessment [ Time Frame: Annual for 5 years ]
    Conner's Adult Attention Deficit Disorder Rate Scale (CAADDR)

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Montana
Regenevita LLC
Stevensville, Montana, United States, 59870
Sponsors and Collaborators
Robert W. Alexander, MD, FICS
Investigators
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Principal Investigator: Robert W. Alexander, MD GARM International and GARM USA
Principal Investigator: Glenn C Terry, MD GARM
More Information
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Publications:

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Responsible Party: Robert W. Alexander, MD, FICS, Principal Investigator, Healeon Medical Inc
ClinicalTrials.gov Identifier: NCT02959294    
Other Study ID Numbers: RGV GARM 5
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Annual Summary of Case to All Collaborators

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert W. Alexander, MD, FICS, Healeon Medical Inc:
TBI
mTBI
Concussion, Brain
Loss Consciousness, Traumatic
Headaches
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Brain Concussion
Brain Damage, Chronic
Chronic Traumatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating
Brain Injury, Chronic
Neurodegenerative Diseases