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
- 2
- 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)
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