Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19
Overview
- Phase
- Phase 3
- Intervention
- Injection of secretome - mesenchymal stem cell
- Conditions
- COVID-19
- Sponsor
- Indonesia University
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Assessment of inflamation marker levels
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Murdani abdullah
Prof. M.D., PhD, FACG, FASGE
Indonesia University
Eligibility Criteria
Inclusion Criteria
- •All individuals aged 18 to 65 years
- •It has been confirmed positive for COVID-19 by throat swab / sputum / brochoalveolar lavage (BAL) with real-time reverse transcription polymerase chain reaction (RT-PCR)
- •Categorized as a severe case of COVID-19 patient
- •Agree to participate and sign the informed consent
Exclusion Criteria
- •History of allergy to penicillin, streptomycin, and amphotericin-B
- •Have any cancer conditions
- •Active in other intervention studies
- •Have had other intervention studies in the last 3 months
Arms & Interventions
Secretome - mesenchymal stem cell group (n = 20)
This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy
Intervention: Injection of secretome - mesenchymal stem cell
Secretome - mesenchymal stem cell group (n = 20)
This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy
Intervention: Standard treatment of Covid-19
Control ( n= 20)
This group will be given placebo and COVID-19 standard therapy
Intervention: Placebo
Control ( n= 20)
This group will be given placebo and COVID-19 standard therapy
Intervention: Standard treatment of Covid-19
Outcomes
Primary Outcomes
Assessment of inflamation marker levels
Time Frame: Day 0 (before intervention), day 7, day 14
The inflamatory marker assessed in this study is IL-6, IL-10, LIF, VEGF, and Ferritin. The inflamatory marker level will assess on day 0 (before intervention), day 7 after intervention, and day 14 after intervention.
Secondary Outcomes
- Mortality rate(maximum 14 days after intervention)
- Assessment of clinical outcome(before and after intervention (maximum 14 days after intervention))
- Assessment of photo thorax(before and after intervention (maximum 14 days after intervention))
- Assessment of RT-PCR conversion(before and after intervention (maximum 14 days after intervention))
- Assessment of laboratory routine(before and after intervention (maximum 14 days after intervention))