Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries

Concussion, Brain Clinical Trial

— C-TBI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02959294
• Other study ID #: RGV GARM 5
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: November 30, 2018
• Est. completion date: March 2024

Study information

• Verified date: February 2021
• Source: Healeon Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Damage, Chronic
• Brain Diseases
• Brain Injuries
• Brain Injuries, Traumatic
• Chronic Traumatic Encephalopathy
• Concussion, Brain
• Concussion, Intermediate
• Concussion, Mild
• Concussion, Severe
• Traumatic Encephalopathies, Chronic

Intervention

Procedure:
• Microcannula Harvest Adipose
Use of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells

Device:
• Centricyte 1000
Use of Centricyte 1000 Closed System Digestion Autologous AD-tSVF to create AD-cSVF

Procedure:
• Sterile Normal Saline IV deployment AD-cSVF
Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use

Locations

Country	Name	City	State
United States	Regenevita LLC	Stevensville	Montana

Sponsors (1)

Lead Sponsor	Collaborator
Robert W. Alexander, MD, FICS

Country where clinical trial is conducted

United States, 

References & Publications (20)

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Concussion (mild traumatic brain injury) and the team physician: a consensus statement. Med Sci Sports Exerc. 2005 Nov;37(11):2012-6. — View Citation

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Kumar R, Husain M, Gupta RK, Hasan KM, Haris M, Agarwal AK, Pandey CM, Narayana PA. Serial changes in the white matter diffusion tensor imaging metrics in moderate traumatic brain injury and correlation with neuro-cognitive function. J Neurotrauma. 2009 Apr;26(4):481-95. doi: 10.1089/neu.2008.0461. — View Citation

Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. — View Citation

Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9. Review. — View Citation

Maroon JC, Lovell MR, Norwig J, Podell K, Powell JW, Hartl R. Cerebral concussion in athletes: evaluation and neuropsychological testing. Neurosurgery. 2000 Sep;47(3):659-69; discussion 669-72. Review. — View Citation

Parikh S, Koch M, Narayan RK. Traumatic brain injury. Int Anesthesiol Clin. 2007 Summer;45(3):119-35. Review. — View Citation

Pearce JM. Observations on concussion. A review. Eur Neurol. 2008;59(3-4):113-9. Epub 2007 Nov 30. Review. — View Citation

Pellman EJ, Viano DC; National Football League's Committee on Mild Traumatic Brain Injury. Concussion in professional football: summary of the research conducted by the National Football League's Committee on Mild Traumatic Brain Injury. Neurosurg Focus. 2006 Oct 15;21(4):E12. — View Citation

Randolph C. Baseline neuropsychological testing in managing sport-related concussion: does it modify risk? Curr Sports Med Rep. 2011 Jan-Feb;10(1):21-6. doi: 10.1249/JSR.0b013e318207831d. Review. — View Citation

Saatman KE, Duhaime AC, Bullock R, Maas AI, Valadka A, Manley GT; Workshop Scientific Team and Advisory Panel Members. Classification of traumatic brain injury for targeted therapies. J Neurotrauma. 2008 Jul;25(7):719-38. doi: 10.1089/neu.2008.0586. — View Citation

Thornton KE, Carmody DP. Efficacy of traumatic brain injury rehabilitation: interventions of QEEG-guided biofeedback, computers, strategies, and medications. Appl Psychophysiol Biofeedback. 2008 Jun;33(2):101-24. doi: 10.1007/s10484-008-9056-z. Epub 2008 Jun 13. Review. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	Activities of Daily Living (ADL)	Outcome measures at baseline at 6 month
Primary	Cognitive Change in clinical symptoms associated with concussion-TBI	Montreal Cognitive Assessment Scale (MCAS)	Outcome measures at baseline and reviewed 1 year interval for average time 5 years
Secondary	Beck's Depression Inventory (BDI)	Multiple choice self reporting measure of depression	Annual for 5 years
Secondary	Adult Attention Deficit Assessment	Conner's Adult Attention Deficit Disorder Rate Scale (CAADDR)	Annual for 5 years
Secondary	MRI Brain With & MRI Brain With & Without Contrast	MRI Brain to evaluate progressive changes comparing pre-treatment (0), 3 year and 5 year status	0, 3 years, 5 years