Efficacy and Safety of EXOSOME-MSC Therapy to Reduce Hyper-inflammation In Moderate COVID-19 Patients
Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
In COVID-19 infection caused by the Severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2), there is a dysregulation of the immune system response that causes cytokine
storm syndrome. SARS-CoV-2 works like a hijacker (hackers), sabotaging communication between
cells so that the immune system, like T-cells, kills not only infected cells but also healthy
cells. This dysregulation results in hyper-inflammation which cause damage to organs, not
just the lungs. This is the cause of the high mortality rate in COVID-19 patients.
Exosomes are vesicles with a size of 30-100 nanometers originating from within cells that
function to communicate with other cells. Exosomes are transport containers that contain
bioactive cargo: such as proteins, genetic material, and various other molecules. These
containers move from cells of origin, flowing through blood vessels or other body fluids to
target cells. Exosomes penetrate the cell membrane and act on various organelles within the
target cell.
All cell types can produce exosomes. What differentiates them is the cargo they contain. The
exosome produced by mesenchymal stem cells (MSCs) contains bioactive cargo derived from
mesenchymal stem cells, such as anti-inflammatory cytokines, growth factors, messengerRNA
(mRNA) and microRNA (miRNA). The target cells are immune system cells, infected cells and
progenitor cells from infected organs. On target immune cells, the anti-inflammatory
cytokines work as immunomodulators to relieve hyper-inflammation. In infected cells, the
miRNAs work to prevent viral replication by inhibiting the expression of SARS-CoV-2 virus RNA
(viral mRNA silencing and degrading). In lung progenitor cells and other infected organs, the
growth factors work to stimulate protein synthesis processes that function for organ
regeneration.
This study is a multi-center, double-blind, randomized controlled trial (RCT) clinical trial
with two arms: one intervention arm, and one control arm. The EXOSOME-MSC will be tested as
adjuvant, on top of standard COVID-19 drugs. It will be injected to participants via
intravenous route twice, in day-1 and day-7 of 14 days of study participation.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Dermama Bioteknologi Laboratorium
Collaborator:
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia