Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic Multipotent Mesenchymal Stem Cells of the Placenta and Umbilical Cord
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio.
研究概览
简要总结
Assessment of the clinical effects of infusions of cryopreserved allogeneic multipotent mesenchymal stem cells of the placenta and umbilical cord for COVID-19 patients with acute respiratory distress syndrome.
详细描述
Currently, cell-based therapy and especially stem cell therapy has become a promising therapeutic field, in which many see opportunities to cure incurable diseases. Severe respiratory consequences of the COVID-19, the disease caused by the novel SARS-CoV-2 coronavirus, have prompted urgent need for novel therapies.
Cell-based approaches, primarily using mesenchymal stem cells (MSCs), have demonstrated safety and efficacy in patients with the acute respiratory distress syndrome (ARDS) - common manifestation of cytokine storms, and the cause of death in many COVID-19 patients.
Mesenchymal stem cells are a powerful immunomodulator, they secrete many anti-inflammatory biologically active substances (cytokines) that reduce the inflammatory process in the lungs. Also mesenchymal stem cells secrete numerous growth factors that contribute to the recovery of not only the affected lung tissue but also other organs.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged at 18 years (including) - 75 years old.
- •Laboratory confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source.
- •Pneumonia that is judged by X-ray imaging.
- •In accordance with any one of the following:
- •dyspnea (RR ≥ 30 times / min);
- •finger oxygen saturation ≤ 93% in resting state;
- •arterial oxygen partial pressure (PaO2) / oxygen absorption concentration (FiO2) ≤ 300MMHG (if possible);
- •invasive ventilation< 48 h.
排除标准
- •Male or female, aged at <18 years and > 75 years old.
- •Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures.
- •Patients with malignant tumor, other serious systemic diseases and psychosis.
- •Patients who are participating in other clinical trials.
- •Inability to provide informed consent or to comply with test requirements.
- •Co-Infection of HIV, syphilis.
- •Invasive ventilation > 48 h.
- •Combined with other organ failure (need organ support).
研究组 & 干预措施
Experimental group
On the basis conventional symptomatic treatment and supportive therapy, P-MMSCs were given at 1 million cells/kg body weight/ time, once every 3 days for a total of 3 times: Day "1", Day "4", Day "7".
干预措施: Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells (Procedure)
Experimental group
On the basis conventional symptomatic treatment and supportive therapy, P-MMSCs were given at 1 million cells/kg body weight/ time, once every 3 days for a total of 3 times: Day "1", Day "4", Day "7".
干预措施: Antibiotics (Drug)
Experimental group
On the basis conventional symptomatic treatment and supportive therapy, P-MMSCs were given at 1 million cells/kg body weight/ time, once every 3 days for a total of 3 times: Day "1", Day "4", Day "7".
干预措施: Hormones (Drug)
Experimental group
On the basis conventional symptomatic treatment and supportive therapy, P-MMSCs were given at 1 million cells/kg body weight/ time, once every 3 days for a total of 3 times: Day "1", Day "4", Day "7".
干预措施: Anticoagulant Therapy (Drug)
Experimental group
On the basis conventional symptomatic treatment and supportive therapy, P-MMSCs were given at 1 million cells/kg body weight/ time, once every 3 days for a total of 3 times: Day "1", Day "4", Day "7".
干预措施: Оxygen therapy (Device)
Control Group
Conventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies
干预措施: Antibiotics (Drug)
Control Group
Conventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies
干预措施: Hormones (Drug)
Control Group
Conventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies
干预措施: Anticoagulant Therapy (Drug)
Control Group
Conventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies
干预措施: Оxygen therapy (Device)
结局指标
主要结局
Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio.
时间窗: up to 28 days
Improvement of pulmonary function. Arterial oxygen tension PaO2 (in mmHg)/fractional inspired oxygen FiO2 (expressed as a fraction, not a percentage), most conveniently the P/F ratio. The normal P/F ratio is \~ 400-500 mmHg (\~55-65 kPa). P/F ratio \<300mmHg - sign of Acute Respiratory Distress Syndrome (ARDS)
Changes in length of hospital stay
时间窗: up to 28 days
Length of Hospital Stay
Changes in mortality rate
时间窗: up to 28 days
Marker for efficacy of treatment
次要结局
- Changes of С-reactive protein (CRP, mg/L)(At baseline, Day 1, Week 1, Week 2, Week 4, Week 8)
- Evaluation of Pneumonia Improvement(At baseline, Day 1, Week 1, Week 2, Week 4, Week 8)
- Duration of respiratory symptoms (difficulty breathing, dry cough, fever, etc.)(At baseline, Day 1, Week 1, Week 2, Week 4, Week 8)
- Peripheral blood count recovery time(At baseline, Day 1, Week 1, Week 2, Week 4, Week 8)