Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
WithdrawnEarly phase 1NCT02959294
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Use of Adipose-Derived Cellular Stromal Vascular Fraction (AD-cSVF) Parenterally in Post-Concussion Injuries and Traumatic Brain Injuries (TBI)
- Conditions
- Traumatic Encephalopathies, Chronic
- Concussion, Mild
- Concussion, Intermediate
- Concussion, Severe
- Concussion, Brain
- Interventions
- Procedure: Microcannula Harvest Adipose
- Device: Centricyte 1000
- Procedure: Sterile Normal Saline IV deployment AD-cSVF
- Sponsor
- Robert W. Alexander, MD, FICS
- Organization
- Healeon Medical Inc
- Start date
- 2018-11-30
- Primary completion
- 2023-11
- Sex
- All
- Age range
- from 16 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02959294