Therapeutic Study to Evaluate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Frailty Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety evaluation
研究概览
简要总结
Subjects will be provided a written informed consent to participate in the study and then undergo any screening. Subjects who meet all the inclusion criteria and none of the exclusion criteria based on the screening test results will be included into the study. At treatment day, the subjects will be administered 100 million cells of investigational product for 30 minutes for each package using a syringe pump. After 4 weeks (1 month) of Investigational product administration, the subjects will visit the study site to evaluate the safety and efficacy of investigational products. Follow up visits for potential efficacy will also be conducted after 12 weeks (3 months) and 24 weeks (6 months) of Investigational product administration. If necessary, additional examination and treatment may be performed according to the investigator's judgment
详细描述
Frailty is defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems such that the ability to cope with every day or acute stressors is comprised. The prevalence of frailty varies between populations in different countries. A meta-analysis conducted from 240 studies across 62 countries, using the Frailty Index, showed that the prevalence of frailty and prefrailty among elderly people is 24% and 49%, respectively. In Indonesia, a meta-analysis showed that, using the frailty index, the prevalence of frailty and pre-frailty among elderly people is 26.8% and 55.5%, respectively. These data indicate that the prevalence of frailty and prefrailty in Indonesia is above the world average. This high prevalence of frailty in Indonesia will also become a serious problem, especially considering the various burdens that may arise as a result of frailty, such as geriatric syndromes, disability, mortality, and even cognitive impairment.
Stem cell therapy is proven to help reversing and slowing the progression of physical frailty through: improving the age-dependent senescence, restoring the frailty-related stem cell depletion, inhibit chronic inflammation, improving imbalance of immune homeostasis, restoring the reduction of multipotent stem cells. Mesenchymal Stem Cell (MSC) as one of the options for therapy of frailty becoming one of the future promising treatments. Umbilical Cord-derived Mesenchymal Stem Cell (UC-MSCs) become one of the popular types of Mesenchymal Stem Cell (MSC)'s origin, not only because of its promising immunomodulatory and anti-inflammatory properties, but also because of its safety and less ethical issues. Mesenchymal Stem Cell (MSC) proven too able to contribute in improving frailty condition through components, including neuroprotective effect, cardioprotective effect, muscle protective effect, and therapeutic effect on hormone. This study aimed to evaluate the safety and potential therapeutic effect of allogeneic human mesenchymal stem cell infusion in frailty patients.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 60-85 years old at the time of screening
- •Those who have been confirmed frailty indication through The Frail questionnaires
- •Those who voluntarily decided to participate in the study and wrote the informed consent form
- •Those who are suitable as subjects for this study when judged by physical examination, clinical test, medical test, et cetera
排除标准
- •Subject that not able to perform any of the assessments required for endpoint analysis
- •Those who have hypersensitivity reaction or a history of hypersensitivity to the components of the investigational product or the investigational product
- •Subject with Mini Mental State Examination (MMSE) score less than 24
- •Abnormal laboratory result, including Hemoglobin (Hb) <8 g/dl, Leukocyte <3000/mm3, platelets <80,000/mm3, International Normalized Ratio (INR) > 1.5, aspartate transaminase and alanine transaminase > 3 times upper limit of normal, total bilirubin > 1.5 mg/dl, serum creatinine > 2 mg/dL
- •Organ transplant recipient or already listed (or expected to be listed) for transplantation of any organ
- •Patient taking immunosuppressive drugs within 6 months of screening
- •Having serious comorbidities that may compromise the safety and compliance of the patient based on investigator judgement, including but not limited to: 1) Heart: unstable angina, myocardial infarction, class III/IV congestive heart failure, cardiac revascularization within the last six months, 2) Liver: Advanced liver failure, 3) Renal: Advanced renal failure, 4) Pulmonary: Severe obstructive ventilatory defect, history of pulmonary embolism, 5) Other: Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), Hepatitis B Surface Antigen (HBsAg) positive, Hepatitis C virus (HCV) positive, uncontrolled hypertension, uncontrolled blood glucose
- •Patient who had cancer disease within 5 years and no malignancy suspected from the result of tumor marker screening
- •Patient that participating in other investigational therapeutic or device trial
- •Patient with life expectancy less than 1 year
- •Patient who are pregnant, nursing, and/or having a childbearing potential while not having effective contraceptive method
- •Those who are determined by the investigator to be unsuitable for participation in the clinical trial due to other reasons including the results of the clinical laboratory test
研究组 & 干预措施
100 million cells of investigational product for 30 minutes per package using a syringe pump.
100 million cells of investigational product for 30 minutes per package using a syringe pump.
干预措施: Daewoong Biologics Indonesia Umbilical Cord-derived Mesenchymal Stem Cell (DBI UC-MSC) (Biological)
结局指标
主要结局
Safety evaluation
时间窗: 1, 3, and 6 months
Safety evaluation will be measured by the incidence of Serious Adverse Events (SAEs)
Safety evaluation
时间窗: 2 hours, 1 month, 3 months, and 6 months
Safety will be assessed by evaluating thromboembolism risk as indicated by d-dimer level
Efficacy evaluation (Frailty state)
时间窗: 1, 3, and 6 months
Frailty state condition will be evaluated using the Frail questionnaires
Efficacy evaluation (Patient quality of life)
时间窗: 1, 3, and 6 months
Patient quality of life will be evaluated using Short-Form 12 Health Survey (SF-12)
Efficacy evaluation (Inflammatory biomarkers)
时间窗: 1, 3, and 6 months
Inflammatory biomarkers will be evaluated using TNF-α (Tumor necrosis factor-alpha), IL-6 (Interleukin-6), IL-10 (Interleukin-10), and IL-11 (Interleukin 11),
Efficacy evaluation (Immune system biomarkers)
时间窗: 1, 3, and 6 months
Immune system biomarkers will be evaluated including Cluster of Differentiation-4 (CD4) and Cluster of Differentiation-8 (CD8)
次要结局
未报告次要终点