Adjuvant Therapy With Mesenchymal Stem Cells in Patients Diagnosed With COVID-19 in Critical Condition
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change form baseline in Arterial oxygen saturation
研究概览
简要总结
The propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the intensive care unit of the Regional Hospital Lic. Adolfo López Mateos of the Institute for Social Security and Services for State Workers to reduce cytokine storm and contribute to the favorable resolution of respiratory insufficiency and multiple organic failure.
详细描述
Within the epidemic context of phase 3 that currently exists in Mexico, implementation of new treatments that have shown to be beneficial for patients in a critical state in other countries is an urgent need. Adipose tissue derived-mesenchymal stem cells for could favor the regulation of patient immune system to reduce the proinflammatory state and promoting the regeneration of damaged tissues.
Patients diagnosed COVID-19 and confirmed positive with the virus by PCR, will be treated with two intravenous infusions MSCs on the day 1 (D1) and the day 3 (D3) of the treatment consisting of 1X106/kg each.
We will assess the pulmonary lesion area by chest x-ray or computed axial tomography at baseline and days 2, 3, 5, 10, 15, 20, and 25.
Days to clinical improvement (to be evaluated on days 2, 3, 5, 10, 15, 20, 25), considering temperature and other vital signs measurement, arterial oxygen saturation, blood chemistry (including liver function tests), creatine phosphokinase, C reactive protein, immune cells (CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes), pro-inflammatory cytokines (IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10), immunoglobulins (IgA, IgG, IgM, and IgE), HLA profile expression, and weaning from mechanical ventilation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and
- •RT-PCR positive for SARS-CoV-2 (Berlin protocol).
- •Moderate to severe acute respiratory insufficiency (100 mmHg <PaO2/FiO2 ≤ 200 mmHg).
- •Confirmatory diagnosis of pulmonary injury by chest teleradiography or computed axial t tomography.
- •Being under standard therapy for COVID-
- •Informed consent signed by the patient or a legally acceptable representative (in the case of the legal representative, informed consent could be obtained by a phone call or email with the subsequent written confirmation).
排除标准
- •Reserved prognosis (survival expected by the physician of fewer than three days).
- •Being under immunosuppressive drug treatment.
- •Severe kidney failure (estimated glomerular filtration rate < 30 ml/min) or under continuous kidney replacement therapy, hemodialysis, or peritoneal dialysis.
- •Immunosuppressed patients (except when the cause is corticosteroid treatment).
- •Pregnant or lactating women.
- •Patients who plan to become pregnant during the study period or within six months after the end of the study period.
- •Participation in another clinical trial with an experimental drug during the last 30 days.
- •Pathologies that in medical judgment constitute a contraindication to participate in the study.
研究组 & 干预措施
MSC transfusion
干预措施: MSC (Biological)
Control
干预措施: Control (Drug)
结局指标
主要结局
Change form baseline in Arterial oxygen saturation
时间窗: up to 25 days
Aretrial oxygen saturation will be taken by an oximeter
Days to clinical improvement
时间窗: up to 25 days
Number of days of patient discharge
次要结局
- Change Form Baseline Immune cells: CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes(up to 25 days)
- Change Form Baseline in C reactive protein at 25 days(up to 25 days)
- Change Form Baseline in pro-inflammatory cytokines: IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10(up to 25 days)
- Change Form Baseline in Immunoglobulins; IgA, IgG, IgM, and IgE.(up to 25 days)
研究者
M. Eunice Rodríguez Arellano
MD
Hospital Reg. Lic. Adolfo Lopez Mateos