Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Moderate Neurocognitive Impairment (Dementia)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of moderate dementia patients with normal range of blood parameters assessed by hemoglobin level, hematocrit level, leukocyte level, thrombocyte level, HbA1c level, kidney function and liver function
研究概览
简要总结
The goal of this clinical trial if to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with moderate dementia. The main questions it aims to answer are:
- Is HUCMSC derived secretome safe to be use as a therapy in patients with moderate dementia?
- How does HUCMSC derived secretome affect pro inflammatory and anti inflammatory cytokine (IL-6 and TNF alfa) in patient with moderate dementia?
- What is the relationship between HUCMSC derived secretome therapy with mini mental state examination? Researchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored)
Participants will
- Be injected with HUCMSC derived secretome or Vitamin B12 every two weeks for 4 months
- Follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment) and participants will do several blood test and mental examination
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 60 years old
- •Patient diagnosed with dementia confirmed by psychiatrist or neurologist based on DSM-4 or ICD 10
- •Patient with Mini-Mental State Examination (MMSE) between 10 to 20 indicating moderate cognitive impairment
- •Patient is in stable condition without life threatening disease or uncontrolled medical condition
- •Patient undergoing stable dose treatment for other medical condition at least 4 months before the trial
- •Patient with care giver or supporting family who can assist patient with research protocol
排除标准
- •Patient has dementia due to other medical condition such as severe head trauma, brain infection or history of drug abuse
- •Patient with uncontrolled medical condition such as severe cardiovascular disease, chronic lung disease, cancer, or systemic infection
- •Patient with severe psychiatry disorder such as schizophrenia and bipolar disorder
- •Patient is receiving experimental drugs or participates in experimental studies for the last 30 days before the trial
- •Patient who has allergy or hypersensitivity reaction towards secretome
- •Patient with medical complications or surgery complications that require immediate interventions or other life threatening complications
- •Patient is unable to provide written informed consent and not capable to understand and comply to research protocol
- •Patient is unwilling and not capable to follow research protocol including follow up evaluations and blood sampling according to schedule
研究组 & 干预措施
Secretome injection
patient will receive secretome injection every two weeks for four months
干预措施: Secretome injection (Drug)
Vitamin B12
patient will receive 1 ampule of vitamin b12 every two weeks for 4 months
干预措施: Vitamin B12 Injection (Drug)
结局指标
主要结局
Number of moderate dementia patients with normal range of blood parameters assessed by hemoglobin level, hematocrit level, leukocyte level, thrombocyte level, HbA1c level, kidney function and liver function
时间窗: From enrollment to 3 months after treatment
The blood parameters such as hemoglobin, hematocrit, leukocyte, thrombocyte, HbA1c, kidney function and liver function normal range is measured according to international standard
Number of participants with improved Mini mental status examination, mini cog and AD8
时间窗: from enrollment to 3 months after treatment
Participants achieved a response if they have improvement of MMSE score, mini cog score and AD8 score
Number of participants with improved Glial Fibrillary Acid Protein (GFAP) levels
时间窗: from enrollment to 3 months after treatment
Participants achieved a response if there is a decrease in GFAP levels
次要结局
未报告次要终点