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 range16 Years – 70 Years

SexALL

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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

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