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.
Procedure: Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells
i/v infusions
Other Name: P-MMSCs
Drug: Antibiotics
per os
Other Name: ceftriaxone and azithromycin capsules
Drug: Hormones
a moderate amount of dexamethasone i/v
Other Name: dexamethasone
Drug: Anticoagulant Therapy
Sub-Q
Other Name: Еnoxaparin
Device: Оxygen therapy
Оxygen therapy, mechanical ventilation and other supportive therapies
Other Name: Оxygen insufflation
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Institute of Cell Therapy
Kyiv, Ukraine
Investigator: Peter Nemtinov, MD
Contact: +380442079207
nemtinov@stemcellclinic.com
Investigator: Alexey Chibisov, MD
Peter Nemtinov, MD
+380442079207
nemtinov@stemcellclinic.com
Alina Ustymenko, PhD
+380442079207
ustimenko@stemcellclinic.com
Peter Nemtinov, MD, Study Director
Institute of Cell Therapy