NCT02672306Unknown1 期
Clinical Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Mild and Moderate Alzheimer's Disease
South China Research Center for Stem Cell and Regenerative Medicine1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年10月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and the efficacy of (Human Umbilical Cord-Derived Mesenchymal Stem Cells) UCMSCs for patients with Alzheimer's disease (AD).
详细描述
Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Outcomes Assessor), Randomized, Safety/ Efficacy Study Official Title: Multicenter, Randomized, Double-blind, Placebo Controlled Trial of UCMSCs in Subjects With Alzheimer's Disease
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, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 50 to 80, male and female.
- •A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
- •Treatment with other cholinesterase inhibitors, such as a stable dose of donnepiazide tablets (5mg/ day or 10mg/ day) or the use of heavy tartaric acid karbalin capsules, is currently being used.
- •MMSE score between 10 and
- •Voluntarily participating subject who sign the Inform Concent
排除标准
- •Caused by other reasons of dementia (vascular dementia, infectious disease of the central nervous system (such as HIV, syphilitic dementia), g - she's disease, Parkinson's disease, Lou gehrig's disease, huntington's disease DLB, traumatic brain dementia, other physical and chemical factors (such as: drug poisoning, alcoholism, carbon monoxide poisoning and other dementia), important body disease (such as hepatic encephalopathy, pulmonary encephalopathy dementia), intracranial placeholder lesions, endocrine system disease, such as thyroid disease, parathyroid disease), and vitamins and other causes of dementia)
- •The Hamilton depression scale (HAMD) score > 17, or patients with a history of depression or other psychiatric or psychiatric disorders.
- •The Hachinski ischemic index scale (HIS) scored >
- •The brief intelligence status examination scale (MMSE) score of 10 patients.
- •Liver function (ALT, AST) exceeded the normal range limit of 1.5 times, SCr exceeded normal range upper limit, white blood cell count < 4.0 x 109/L or platelet < 100 x 109/L, hemoglobin < 100g/L.
- •Patients with type 1 diabetes, obstructive pulmonary disease (copd) or asthma, vitamin B12 or folate deficiency patients, not control good digestion, liver, kidney, endocrine and cardiovascular system diseases (especially sick sinus syndrome and conduction block), patients with HIV/AIDS, syphilis, active tuberculosis, etc.
- •A person with cancer or a history of cancer.
- •People with a clinically significant history of stroke, who have had a seizure or a head injury in the past two years, have caused the disorder.
- •There is a history of congestive heart failure or a history of myocardial infarction, and a blood disease in two years.
- •Drug clinical trials were performed within 3 months of screening.
- •Anti-ad agents are being used in addition to the programme requirements.
- •The use of stem cell therapy in half a year.
- •People with history of alcoholism and substance abuse, allergies, or history of allergies.
- •Patients who had been hospitalized for more than 3 months before screening. of allergies.
- •The researchers think it is inappropriate to participate in this clinical trial.
研究组 & 干预措施
UCMSCs
Experimental
Subjects with Alzheimer's Disease Intervention: UCMSCs
干预措施: UCMSCs (Biological)
Placebo
Placebo Comparator
Subjects with Alzheimer's Disease Intervention: Placebo (normal saline)
干预措施: Placebo (Biological)
结局指标
主要结局
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
时间窗: 36 weeks from post-administration
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
次要结局
- Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score(10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration)
- Change in Neuropsychiatric Inventory (NPI) Score(10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration)
- Changes in AD Biomarkers(36 weeks from post-administration)
- Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score(10 weeks,18 weeks,24 weeks,48weeks from post-administration)
- Change in Mini-Mental State Examination (MMSE) Score(10 weeks,18 weeks,36 weeks，24 weeks,48weeks from post-administration)
- Change in Clinician's Interview-Based Impression of Change (CIBIC-plus) Score(10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
早期 1 期
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Exosomes in Treating Chronic Cough After COVID-19Long COVID-19 SyndromeNCT05808400Huazhong University of Science and Technology80
尚未招募
2 期
Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-SA) for Patients With Spinocerebellar AtaxiaSpinocerebellar Ataxia Type 1Spinocerebellar Ataxia Type 2Spinocerebellar Ataxia Type 6Spinocerebellar Ataxia Type 3NCT03378414Sclnow Biotechnology Co., Ltd.45
已完成
1 期
Human Umbilical Cord-derived Mesenchymal Stem Cells With Injectable Collagen Scaffold Transplantation for Chronic Ischemic CardiomyopathyChronic Ischemic CardiomyopathyNCT02635464Chinese Academy of Sciences50
Unknown
1 期
Safety and Efficacy of UC-MSCs in Patients With Psoriasis VulgarisPsoriasis VulgarisNCT02491658Affiliated Hospital to Academy of Military Medical Sciences30
Unknown
1 期
Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic CirrhosisHepatic CirrhosisNCT02652351Shenzhen Hornetcorn Bio-technology Company, LTD20