NCT05167552Unknown1 期
Treatment of Patients With Allergic Rhinitis and Chronic Polypous Rhinosinusitis With Olfactory Mucosa-derived Mesenchymal Stem Cells
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus0 个研究点目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 主要终点
- The relapse-free period
研究概览
简要总结
Treatment of patients with allergic rhinitis and chronic polypous rhinosinusitis with olfactory mucosa-derived mesenchymal stem cells
详细描述
During the implementation of the project, the methods for the treatment of allergic rhinitis and chronic polypous rhinosinusitis with olfactory mucosa-derived mesenchymal stem cells will be developed.
The positive outlook for the effectiveness of MSCs is due to the following:
- knowledge of the leading role of immunopathogenetic mechanisms in the development of allergic rhinitis and chronic polypous rhinosinusitis and the pronounced immunomodulating properties of MSCs;
- the ability of MSCs to reduce the production of proinflammatory cytokines and suppress immune inflammation;
- positive results of preclinical studies of the method of treatment of diseases accompanied by over-activation of the immune system, including autoimmune diseases, in animals and the first clinical studies in patients.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of allergic rhinitis or chronic polyposis rhinosinusitis
- •The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
- •Written informed consent
排除标准
- •The presence of any malignant tumor within the last 5 years
- •Acute or chronic diseases in the stage of decompensation
- •Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
- •Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
- •Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
- •Patients are unable or unwilling to give written informed consent and / or follow research procedures
- •Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
结局指标
主要结局
The relapse-free period
时间窗: 1 year
The duration of the relapse-free period
The need for surgical intervention
时间窗: 1 year
The need for surgical intervention
The need for the use of basic drug therapy
时间窗: 1 year
The need for the use of basic drug therapy
Adverse effects associated with the therapy
时间窗: 1 year
Determination of adverse effects associated with the therapy
次要结局
未报告次要终点
研究者
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