Single-group, Open-label, Phase I / II Clinical Trial: Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Cytokines Balance in Inflammaging (Ageing-related Low-grade Inflammation) Patients.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- The safety and toleration of stem cell infusion
研究概览
简要总结
Single-group, open-label, phase I / II clinical trial: Evaluation of the safety of autologous adipose tissue-derived mesenchymal stem cell transplantation in inflammaging (Ageing-related low-grade inflammation) patients.
详细描述
The proposed study is a single-group, open-label, phase I / II clinical trial in which the patients will be treated with two doses (100 million i.v) of autologous adipose tissue-derived mesenchymal stem cell transplantation.
This study aims to evaluate the safety and efficiency of autologous adipose tissue-derived mesenchymal stem cell transplantation in inflammaging (Ageing-related low-grade inflammation) patients. The inflammaging-patients are who have cytokine increasing (IL6 and TNF alfa)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient, age 40 to 64 years.
- •The inflammatory aging patient as defined in the protocol as TNF alpha or IL6 at the time of screening was higher than the 95% healthy percentile value declared by the test system manufacturer.
- •Have at least 2 of the 3 following diseases:
- •Diabetes type II
- •Dyslipidemia
- •Obesity [The diagnosis and determination of accompanying diseases (Diabetes, Dyslipidemia, Obesity) will be carried out according to the general guidance of the MOH Vietnam].
- •Patients are using stable drugs for co-infection (diabetes mellitus, dyslipidemia, obesity) stably in the past 3 months.
- •Agree to participate in research and agree to comply with the research examination and evaluation process.
排除标准
- •Patients with a blood-clotting disorder or hemophilia
- •Patients with severe heart failure
- •Acute respiratory pathology at the time of screening
- •Patients with cancer or other acute illness need treatment.
- •Patients with a history of allergy to anesthetics, anesthesia, and antibiotics
- •Patients are planning to participate in another clinical trial while participating in the study
- •There are other conditions or circumstances in which it is difficult for researchers to ensure adherence to treatment in the judgment of researchers.
结局指标
主要结局
The safety and toleration of stem cell infusion
时间窗: Study endpoint at day 180
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- The change of proinflammatory cytokines after stem cell transplantation in patients(Day 0, Day 90 and Day 180)
- The change of anti-inflammatory cytokines after stem cell transplantation in patients(Day 0, Day 90 and Day 180)
- The influence of stem cell transplantation on thechange of the ratio of pro-inflammatory to anti-inflammatory cytokines(Day 0, Day 90 and Day 180)