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

Withdrawn before enrolling · Early Phase 1

Conditions studied: Traumatic Encephalopathies, Chronic, Concussion, Mild, Concussion, Intermediate, Concussion, Severe, Concussion, Brain

In brief

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.

Key facts

Study ID

NCT02959294

Run by

Robert W. Alexander, MD, FICS

People needed

0

Starts

2018-11-30

Expected to finish

2024-03-01

Last updated by the study team

2021-02-16

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Regenevita LLC — Stevensville, Montana, United States

Full record on ClinicalTrials.gov

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