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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermama Bioteknologi Laboratorium
• Collaborator: Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

Criteria

Inclusion Criteria:

1. Diagnosed with COVID-19 pneumonia confirmed by RT-PCR examination. Samples were obtained from nasopharyngeal swabs in patients with moderate

2. There is evidence of changes in chest X-ray with a picture of COVID-19 pneumonia and/or CT-Scan of the thorax with a ground glass opacity picture

3. Willing to participate in the study and sign the informed consent by the subject or family members.

Exclusion Criteria:

1. Diagnosed with mild COVID-19 pneumonia

2. Pregnant woman or positive pregnancy test

3. The subject is participating in another clinical trial.

4. Have a history of anaphylactic reactions, angioedema, or allergic reactions to antibiotics (penicillin and its derivatives) or other drugs.

5. Have an autoimmune disease

6. Have a history of malignancy

7. Undergoing hemodialysis or peritoneal dialysis

8. Recuring COVID-19 sufferers