Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
Condition: Coronavirus Disease 2019 (COVID-19) Pneumonia
MeSH terms: COVID-19; Pneumonia
Study type: Interventional

Summary: 
      Due to the cytokine storm that develops as a result of Coronavirus Disease 2019 (COVID-19)
      infection, some patients hospitalization to intensive care cause of pneumonia, Acute
      Respiratory Distress Syndrome (ARDS) and multiple organ failure. Mortality is higher in
      treatment-resistant cases.

      Purpose of this study:

        1. Providing immune modulation by Stem Cell Transplantation and reducing the damage caused
           by cytokine storm to tissues and organs,

        2. Correcting immunosuppression and fight against COVID-19 virus by editing B and T cells,

        3. It is to accelerate healing in organ damage by increasing growth factors through
           mesenchymal stem cells.

      Primary outcome: Improvement of clinical symptoms, reduction of cytokine storm Secondary
      outcome: Recovery of patients; from mechanical ventilation
    

Detailed description: 
      Study design and participants This study was a single-center open-label, randomized trial
      conducted at an Education and Training Hospital, Istanbul from May to July, 2020, and it was
      performed according to the Declaration of Helsinki and approved by the Ethics Committee and
      health ministry (No:2020.05.20). Written informed consent was obtained from all patients or
      their representatives when data were collected prospectively.

      Age, gender, mortality status, APACHE II score, number of days in ICU, procalcitonin and
      C-reactive protein values, leukocyte values, comorbid diseases, The cluster of
      differentiations 4 and 8 (CD4 and CD8), interleukin -2, interleukin -6, Tumor necrosis
      factor-alpha-beta levels will be recorded.

      Clinical results, changes in inflammatory and immune function levels, and side effects will
      be recorded. The patient's lung function and symptoms will be recorded after Mesenchymal Stem
      Cell transplantation. After treatment, lymphocyte, C-reactive protein, Tumor Necrosis
      alpha-beta levels , interleukin-6 levels will be recorded.

      Patients were divided into 3 groups:

        1. group: Intubated without comorbidity (n:7)

        2. group: Intubated with comorbidity (n:7)

        3. group: No intubated (n:7)

      Dosage of Mesenchymal stem cells:

        1. 1 million cell/kg iv--------------------------------------------------day 0

        2. 1 million cell/kg iv -------------------------------------------------day 2

        3. 1 million cell/kg iv -------------------------------------------------day 4
    

Intervention name(s): Mesenchymal stem cells
Intervention type(s): Other
Intervention description(s): Intravenous infusion of Mesenchymal stem cells
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Coronavirus Disease 2019 (COVID-19) patients with pneumonia
1.group: Intubated without comorbidity, 2.group: Intubated with comorbidity, 3.group: No intubated
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal stem cells; COVID-19; Pneumonia