NCT05122234

Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-centre randomized controlled trial involving severe covid-19 patients. The intervention group will receive mesenchymal stem cell secretomes and standard covid-19 therapy, while the control group receive placebo and standard covid-19 therapy. Clinical presentation, inflamatory marker, laboratory and radiological parameters, RT-PCR conversion, safety profile, and mortality rate will be monitored for a maximum of 14 days after intervention.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Injection of secretome - mesenchymal stem cell	Secretome will be given once at a dose of 15 ml per administration dissolved in 100 ml of normal saline. The administration is done intravenously for 60 minutes.
OTHER	Placebo	Normal saline
DRUG	Standard treatment of Covid-19	Standard treatment of Covid-19 based on national protocol.

Timeline

• Start date: 2020-08-10
• Primary completion: 2021-07-30
• Completion: 2021-11-14
• First posted: 2021-11-16
• Last updated: 2021-11-16

Locations

4 sites across 1 country: Indonesia