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临床试验/NCT02959294
NCT02959294撤回早期 1 期

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

Robert W. Alexander, MD, FICS2 个研究点 分布在 1 个国家开始时间: 2018年11月30日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
撤回
发起方
试验地点
2
主要终点
Cognitive Change in clinical symptoms associated with concussion-TBI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Cognitive Change in clinical symptoms associated with concussion-TBI

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

Montreal Cognitive Assessment Scale (MCAS)

Number of participants with adverse events

时间窗: Outcome measures at baseline at 6 month

Activities of Daily Living (ADL)

次要结局

  • MRI Brain With & MRI Brain With & Without Contrast(0, 3 years, 5 years)
  • Beck's Depression Inventory (BDI)(Annual for 5 years)
  • Adult Attention Deficit Assessment(Annual for 5 years)

研究者

发起方
Robert W. Alexander, MD, FICS
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Robert W. Alexander, MD, FICS

Principal Investigator

Healeon Medical Inc

研究点 (2)

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