What is the Effect of Mesenchymal Stem Cell Therapy on Seriously Ill Patients With Covid 19 in Intensive Care? (Prospective Double Controlled Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Clinical improvement
研究概览
简要总结
This study aims to use the regenerative and repair abilities of stem cells to fight against the harmful effects of the novel coronavirus Covid-19 and therefore develop a treatment strategy. It is known that fatalities from this virus is largely caused by its damage to lungs and other organs. As the disease progresses, these organs fail and lead to mortality. Our hope is that the stem cell transplantation from healthy donors will repair the damage caused by the virus and result in a healthy recovery.
详细描述
Introduction:
The COVID-19 corona virus epidemic has spread from Wuhan, China to the whole world, and has been declared a pandemic by WHO worldwide. In severe patients, ARDS and multiple organ failure can be seen. This condition is associated with cytokine storm in the body. When the virus invades the body, dentric cells can activate macrophages, lymphocytes and natural killer cells. Mesenchymal stem cells (MKH) not only inhibit the abnormal activation of T lymphocytes and macrophages, but also encourage them to differentiate into regulatory T cell subsets (Treg) clusters and anti-inflammatory macrophages. MSCs application proved therapeutic efficiency during influenza infection resulting in reduced impairment of alveolar fluid clearance and lung injury. This was attributed towards attenuation of pro-inflammatory cytokine secretion, inflammatory cell recruitment and increased alveolar macrophages content.
Aim of study:
- To provide immune modulation to patients with COVID-19 who are taken to intensive care and resistant to treatment by performing MSCs transplantation and to reduce the damage caused by cytokin storm to tissues and organs,
- Correcting immunosuppression in patients and increasing the fight against COVID-19 virus by CD4+T, CD+8T cellular cell arrangement,
- It is to accelerate the recovery in organ damage by increasing growth factors by means of MSCs.
Materials and method:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-60 years old male or female
- •Confirmed 2019-nCoV infection with RT-PCR Laboratory test
- •Confirmed Pneumonia with chest radiography and computer tomography
- •and any of the following criteria:
- •Shortness of breath (RR ≥30/min)
- •Resting finger oxygen saturation 93%
- •Arterial oxygen partial pressure (PaO2)/oxygen absorption concentration (FiO2) ≤ 300MMHG
- •Advancing of focus in Pulmonary imaging to >50% in 24-48 hours
排除标准
- •Those who are not pregnant, breastfeeding and pregnant but who do not take effective contraceptive measures;
- •Patients with malignant tumors, other serious systemic diseases and psychosis;
- •Informed consent is not given or does not comply with the test requirements.
- •Co-infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.
- •Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or co-infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.
- •Obstructive HABP / VABP caused by lung cancer or other known causes; Long-term history of use of immunosuppressive agents;
- •History of epilepsy and need for continuous anticonvulsant therapy or anticonvulsant therapy taken within 3 years;
- •Invasive ventilation
- •Other organ failures
结局指标
主要结局
Clinical improvement
时间窗: 3 months
Improvement of clinical symptoms related to Covid-19 infection (fever, pneumonia, shortness of breath)
次要结局
- Sars-Cov-2 viral infection laboratory test(3 months)
- Blood test(3 months)
- Lung damage improvement(3 months)