NCT04566757Unknown1 期
Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 主要终点
- Safety of Umbilical Cord Blood Plasma Infusion
研究概览
简要总结
This study is designed to investigate the safety of Umbilical Cord Blood Plasma infusions in elderly adults regardless of gender, with age-related cognitive decline. Human clinical data of the use of young plasma appear to show beneficial cognitive effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65-85 years old
- •Evidence of cognitive decline on neuro-cognitive testing
- •Able to participate in research trial for 12 months
- •Women must have documented menopause or infertility determination
- •Ability to receive intravenous infusions
- •Patient or legally authorized representative able to sign informed consent
排除标准
- •Patients receiving any other investigational biologics or drugs
- •History of transfusion reaction
- •Dementia related to specific pathology (Alzheimer's Disease, Alcohol-related, etc.)
- •Inability to participate in cognitive or performance testing
- •History of cancer in the last 5 years
- •History of infectious disease within the previous 12 months
- •Severe kidney (eGFR< 30) and heart failure (Class III/IV)
- •History of Human Immunodeficiency Virus Infection
- •History of Hepatitis B, or C
- •History of immunosuppressive therapy
- •History of organ transplantation
- •Difficulty of obtaining peripheral venous access
- •Allergy to histamine blockers
- •Inability to participate in the clinical trial at any data collection and end points
结局指标
主要结局
Safety of Umbilical Cord Blood Plasma Infusion
时间窗: 6 months
Assessment of Human Leukocyte Antigen (HLA) in recipient following Umbilical Cord Blood Plasma infusion
次要结局
- Assessment of Executive Function(12 months)
- Assessment of Working Memory(12 months)
研究者
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