Evaluation of Safety and Efficiency of Method of Exosome Inhalation in SARS-CoV-2 Associated Pneumonia.
Status:
Completed
Trial end date:
2020-10-20
Target enrollment:
Participant gender:
Summary
Coronavirus is an acute viral disease with prevailing upper respiratory tract infections
caused by the RNA-containing virus of the genus Betacoronavirus of the Coronaviridae family.
Most patients with severe COVID-19 develop pneumonia in the first week of the disease. As the
infection progresses, the infiltration increases, and the affected areas increases. Excessive
and uncontrolled immune system response with rapidly developing fatal cytokine storm plays
the main role in the pathogenesis of acute respiratory distress syndrome (ARDS) due to
SARS-CoV-2 infection.
According to available data, exosomes can regulate inflammation and regenerative processes
due to the change in the concentration of anti-inflammatory cytokines and switch the immune
cell to regenerative secretome. Inhalation of exosomes may reduce inflammation and damage to
the lung tissue and stimulate the regenerative processes.
This protocol has been developed based on the literature, information about the ongoing tests
NCT04276987 (A Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating
Severe Novel Coronavirus Pneumonia) and NCT04384445 (Organicell Flow for Patients With
COVID-19), Patent No 271036826 of 2019. "A method for obtaining and concentrating
microRNA-containing exosomal multi-potent mesenchymal-stromal cells for use in cosmetic and
pharmaceutical products to stimulate regenerative processes and slow down aging.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Collaborators:
Clinics of the Federal State Budgetary Educational Institution SSMU Samara Regional Clinical Hospital V.D. Seredavin