A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of Umbilical Cord Mesenchymal Stem Cells Infusion for Aging Frailty
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety of HUC-MSCs infusion
研究概览
简要总结
The purpose of this clinical study is to answer the questions:
- Is the proposed intervention safe?
- Is the proposed intervention effective in improving the healthy status of subjects with aging frailty?
详细描述
Aging frailty is a clinical syndrome, characterized by a decrease of homeostatic reserves and enhanced vulnerability to endogenous or exogenous stressors, exposing individuals to an increased risk of adverse health-related outcomes. The human umbilical cord (HUC) is a promising source of mesenchymal stem cells (MSCs), compared to embryonic stem cells, HUC-MSCs are noncontroversial with a painless collection procedure and faster self-renewal properties. HUC-MSCs can differentiate into the different germ layers and modulate immune responses. One possible mechanism for the onset and development of aging frailty is the depletion of stem cells. Hence, intravenous infusion of HUC-MSCs is attractive therapy against aging frailty.
This is a randomized, double-blind, placebo-controlled clinical trial. The participants (n = 30) will be randomly distributed into two groups. The HUC-MSCs Group (n = 15) will receive intravenous infusion of mesenchymal stem cells twice over a month (30 days interval), the Control Group (n = 15) will receive the same protocolized intervention with normal saline. Follow-up duration is 6 months after first intervention. The reported serious adverse events（SAEs）will be observed within one month post infusion. The short-item from health survey（SF-36), EuroQol five dimensions questionnaire (EQ-5D) and Fried phenotype scale will be evaluated. Short physical performance battery (SPPB) and plasm biomarkers will be assessed.The assessments will be performed at baseline, 1 month, 3 months and 6 months.
The intent of this study is to explore domains of efficacy of HUC-MSCs through the reduction of signs and symptoms of aging frailty and to evaluate the safety of HUC-MSCs in subjects with aging frailty.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects age ≥60 and ≤80 years at the time of signing the informed consent form.
- •Must show signs of frailty apart from a concomitant condition as assessed by the investigator with a frailty score of 1 to 4 using the Fried Phenotype Scale.
- •Must provide written informed consent.
- •Subjects are expected to live more than 12 months.
排除标准
- •Serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study
- •Advanced liver or renal failure, class III/IV congestive heart failure, myocardial infarction, unstable angina, cardiac revascularization, or severe obstructive ventilator defect.
- •Uncontrolled hypertension or hyperglycemia.
- •Have known allergies to biological drugs or antibiotics.
- •Expecting to receive organ transplantation.
- •Have a clinical history of malignancy or active autoimmune diseases.
- •Have a history of drug or alcohol abuse within the past 24 months.
- •Be serum-positive for HIV, hepatitis BsAg or viremic hepatitis C.
- •Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
- •Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods.
结局指标
主要结局
Safety of HUC-MSCs infusion
时间窗: Within one month post infusion
Safety were assessed by incidence of reported serious adverse events (SAEs) within one month after infusion. An SAE is defined as any untoward medical occurrence that: 1. Results in death 2. Is life-threatening (stroke or non-fatal pulmonary embolism, etc.) 3. Requires inpatients hospitalization or prolongation of hospitalization 4. Results in clinically significant abnormal laboratory test results or abnormal vital signs, based on clinical judgment.
次要结局
- Difference in rate of decline of Frailty(Baseline, month 1, 3 month and 6 months post infusion)
- Difference in subject quality of life assessments(Baseline, month 1, month 3 and month 6 post infusion)
- Changes in the pro-inflammatory cytokines of blood sample between the HUC-MSC and placebo cohorts(Baseline, month 1, month 3 and month 6 post infusion)
- Changes in cellular components of the immune system between the HUC-MSC and placebo cohorts(Baseline, month 1, month 3 and month 6 post infusion)