WithdrawnEarly Phase 1

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

Stopped: COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]\]

United States0Started 2018-11-30

Plain-language 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.

Who can participate

Age range

16 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events

Timeframe: Outcome measures at baseline at 6 month

Cognitive Change in clinical symptoms associated with concussion-TBI

Timeframe: Outcome measures at baseline and reviewed 1 year interval for average time 5 years

Trial details

NCT IDNCT02959294

SponsorRobert W. Alexander, MD, FICS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11

View on ClinicalTrials.gov More Traumatic Encephalopathies, Chronic trials