A Randomized, Double-blinded and Placebo-controlled Pilot Clinical Trial to Evaluate the Potential Efficacy and Safety of Human Umbilical Cord Blood and Plasma by Clinical Markers of Frailty in Adult Who Defined Pre-Frailty
试验速览
- 阶段
- 1 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
研究概览
简要总结
This study aims to carry out a safety evaluation of human cord blood and frozen plasma as treatment for pre-frailty , to assess whether the treatment can prevent and improve the aging process, and to identify useful clinical markers of frailty.
The study is a randomized, double-blinded and placebo-controlled pilot clinical Trial conducted at CHA clinical trial institute.
详细描述
Assessment criteria for the study include (1) clinical indicators-weight loss, a decrease in physical activity, weak grip strength, depression; (2) Short Physical Performance Battery(SPPB); (3) SF-36; (4)cardiac output; (4)biomarkers for oxidative stress, inflammation and immune response; (5) methylation; (6) mitochondria DNA copy number; (7) growth factors; (8) antioxidant capacity; (9) hormone assay; (10) genome assay; (11) metabolite; (12) safety of intravenous administration.
Participants will be randomly assigned to three experimental groups and one control group in a ratio of 1:1:1:1. At second visit, the participants will be administered with experimental and placebo agents. Follow-up visits are expected to be at 7 days, 1 and 6 months after the first treatment. Sixth visit is the completion of it.
Primary end points are defined as severe clinical abnormalities, which could be observed until 1 month after administration of blood-derived products, including death, pulmonary embolism, stroke, respiratory stress and hospitalization due to abnormal findings in laboratory tests.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of pre-frailty
- •One or two scores in Simple FRAIL questionnaire
- •Aged 55 or over
- •Willing and able to be hospitalized according to the research plan
- •Able to participate in our research during 12 months
- •For women, they must be diagnosed with menopause or infertility
排除标准
- •Diagnosis of being irreversible disabled
- •Dementia or cognitive impairment clinically relevant to it
- •Unable to perform tasks required for analysis of primary end point
- •Scheduled to receive organ transplantation
- •Hemoglobin < 8 g/dl; white blood cells count <3000/mm3; absolute Neutrophil count < 500/dl; Thrombocyte count <80,000/mm3; , AST/ALT or ALP > 3 times the normal level
- •Hemoglobin >17g/dl for male and >16 g/dl for female
- •Diagnosis of cancer within 5 years or having the possibility to contract cancer
- •Anticancer chemotherapy and radiation therapy
- •History (within 6 months) of acute diseases such as myocardial infarction, unstable angina, stroke, bone fracture
- •Hormone therapy within 6 months
- •Recent and current use of Immunosuppressive drug or HIV patients
- •History of hospitalization due to infectious disease such as pneumonia within one year
- •Previous (within one months) or current participants in other clinical trials
- •Severe kidney (eGFR< 30) and heart failure (Class III/IV)
- •Any participants who, in the opinion of the investigators, are considered to have safety problems and/or not to perform tasks successfully
- •History of drug or alcohol abuse
- •Chronic Hepatitis B or C: history taking
- •Known or suspected pregnancy (Women must be subjected to pregnancy test)
- •Hypersensitive to dimethyl sulfoxide(DMSO)
研究组 & 干预措施
Fresh cord blood(experimental group A)
16 males and 16 females are assigned to the experimental group A. Dropout is 20 percent in each gender.
干预措施: Fresh cord blood(experimental group A) (Other)
Frozen cord blood(experimental group B)
16 males and 16 females are assigned to the experimental group B. Dropout is 20 percent in each gender.
干预措施: Frozen cord blood(experimental group B) (Other)
Frozen plasma(experimental group C)
16 males and 16 females are assigned to the experimental group C. Dropout is 20 percent in each gender.
干预措施: Frozen plasma(experimental group C) (Other)
Placebo group
16 males and 16 females are assigned to the Placebo group. Dropout is 20 percent in each gender. Total participants are 64 in males and 64 in females.
干预措施: Placebo group (Other)
结局指标
主要结局
Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects
时间窗: 7 days after transplantation
The investigators will assess changes in scores from baseline at 7 days after transplantation. After normality test, either unpaired t-test or wilcoxon rank sum test will be conducted.
次要结局
- Biomarkers for oxidative stress and inflammation as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects(Up to 6 months after transplantation)
- Changes in scores of Short Physical Performance Battery (SPPB) as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Hand grip strength (in kg) as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Telomere length as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Body composition as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- DNA damage extent (8-hydroxyguanine level) as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- SF_36(The Short Form (36) Health Survey) as a measure of improvement in the quality of life(6 months period after transplantation)
- Biomarkers for immune response as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Aging-related genetic and epigenetic markers as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- mitochondria DNA copy number as a measure of efficacy for anti-aging effects(6 months period after transplantation)
- Aging-related growth factors(GDF11, GDF15, Myostatin) as a measure of efficacy for anti-aging effects(6 months period after transplantation)
研究者
Myung Ryool Park
Professor
Bundang CHA Hospital