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

February 14, 2021 updated by: Robert W. Alexander, MD, FICS

Use of Adipose-Derived Cellular Stromal Vascular Fraction (AD-cSVF) Parenterally in Post-Concussion Injuries and Traumatic Brain Injuries (TBI)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Stevensville, Montana, United States, 59870
        • Regenevita LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: Outcome measures at baseline at 6 month
Activities of Daily Living (ADL)
Outcome measures at baseline at 6 month
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)
Outcome measures at baseline and reviewed 1 year interval for average time 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck's Depression Inventory (BDI)
Time Frame: Annual for 5 years
Multiple choice self reporting measure of depression
Annual for 5 years
Adult Attention Deficit Assessment
Time Frame: Annual for 5 years
Conner's Adult Attention Deficit Disorder Rate Scale (CAADDR)
Annual for 5 years
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
0, 3 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert W. Alexander, MD, FICS

Investigators

  • Principal Investigator: Robert W. Alexander, MD, GARM International and GARM USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2018

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 7, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 14, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGV GARM 5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Annual Summary of Case to All Collaborators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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