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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
i/v infusions
per os
a moderate amount of dexamethasone i/v
Institute of Cell Therapy
Kyiv, Ukraine
RECRUITINGChanges of oxygenation index PaO2/FiO2, most conveniently the P/F ratio.
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)
Time frame: up to 28 days
Changes in length of hospital stay
Length of Hospital Stay
Time frame: up to 28 days
Changes in mortality rate
Marker for efficacy of treatment
Time frame: up to 28 days
Changes of С-reactive protein (CRP, mg/L)
Infection biomarker. Serum CRP levels can be used for early diagnosis of pneumonia, patients with severe pneumonia had high CRP levels.
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Evaluation of Pneumonia Improvement
CT assessment of pulmonary lesions and lung tissue changes
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Duration of respiratory symptoms (difficulty breathing, dry cough, fever, etc.)
Indirect response to lung function
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Peripheral blood count recovery time
Degree of infection
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
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Sub-Q
Оxygen therapy, mechanical ventilation and other supportive therapies