Determining Overall Improvement in the Quality of Life of Individuals Receiving Human Umbilical Cord Blood Plasma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 主要终点
- The Short Form (36) Health Survey (SF 36)
研究概览
简要总结
This study aims to look at whether human umbilical cord blood plasma (HUCBP) is safe for intravascular (iv) administration; and whether it provides any reversal of frailty or other age-related biological measures.
详细描述
Participants that take part in this experimental treatment will receive six HUCBP infusions over a six month period, with a final check-up occuring six months after the last infusion. Blood samples will be collected before receiving each HUCBP infusion, and at the last check-up. Participants will also be asked to complete a medical questionnaire (SF 36) prior to the first infusion, and prior to each subsequent infusion. The medical questionnaire is four (4) pages in length and includes comprehensive questions about previous medical health and history.
Participation in the experimental treatment will involve monitoring by the Principal Doctor for a period of twelve months after the initial infusion of HUCBP. A second infusion is planned for one month after the initial infusion, a third infusion is planned for two months after the initial infusion, a fourth infusion is planned for three months after the initial infusion, a fifth infusion is planned for four months after the initial infusion,and a sixth infusion is planned for five months after the initial infusion. Participants will be asked to undergo the same blood tests and physical examinations performed at the time of the initial infusion at each of the five subsequent infusions (i.e. at one, two, three, four, and five months after the initial infusion). Twelve months after the initial infusion participants will be asked to attend for final blood tests and physical examinations. There will be no HUCBP infusion at the twelve-month visit.
Assessment criteria for the study include: (1) Short Form (36) Health Survey (SF 36); (2) Biomarkers of inflammation, oxidative stress, and growth factors; (3) Adrenal cortical hormone levels; (4) Telomere length; (5) Hand grip strength; (6) Body fat measurement; (7) DNA damage; and (8) Overall safety of intravenous administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 50 or older
- •Be willing and able to participate during the 12 month research period
- •Women - must be diagnosed with infertility or menopause
排除标准
- •Unable to perform tasks required for analysis of end points
- •History of being hospitalized dues to infectious disease, such as pneumonia, within the last year
- •Recent and current use of immunosuppressive drugs or HIV patients
- •Scheduled to receive organ transplant
- •Dementia or clinically relevant cognitive impairment
- •Participants of previous (within 1 month) or current clinical trials
- •Severe heart and kidney failure
- •History of alcohol or drug abuse
- •Known or suspected pregnancy
- •Chronic Hepatitis B or C
- •Diagnosis of cancer within 5 year of the study, or the possibility to contract cancer
- •Anticancer chemotherapy and radiation therapy
研究组 & 干预措施
Human Umbilical Cord Blood Plasma
Six intravenous infusions of human umbilical cord blood plasma (HUCBP) during a twelve month study period. The amount of HUCBP being infused on each occasion is 50 mL.
干预措施: Human Umbilical Cord Blood Plasma (Biological)
结局指标
主要结局
The Short Form (36) Health Survey (SF 36)
时间窗: The investigators will determine changes in SF 36 scores collected at baseline and at 1 month after HUCBP infusion.
SF 36 as a measure quality of life improvements compared to baseline
次要结局
- Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects.(Testing will occur using blood samples that will be collected the day before the first infusion and 1 month after HUCBP infusion)
- Extent of DNA damage as a measure of efficacy for anti-aging effects(White blood cells isolated from blood samples collected the day before the first infusion and 1 month after HUCBP infusion.)
- Hand grip strength as metric of anti-aging effects(Each participant will perform the grip strength test on the day of the first infusion (baseline) and 1 month after HUCBP infusion)
- Biomarkers of inflammation and oxidative stress.(Blood samples will be collected the day before the first infusion and 1 month after HUCBP infusion)
- Telomere length as a measure of efficacy for anti-aging effects.(Testing will occur using blood samples that will be collected the day before the first infusion and 1 month after HUCBP infusion)
- Body fat measurements(Body fat measurements of each participant will occur one day before the first infusion and 1 month after HUCBP infusion)