Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of hypoxia-mesenchymal stem cells. The improvement in clinical, laboratory, and radiological manifestations will be evaluated in treated patients compared with the control group.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stem Cell and Cancer Research Indonesia
• Collaborator: Provincial Government of Central Java, Indonesia

Criteria

Inclusion Criteria:

1. Patients whose clinical and laboratory test results have a positive diagnosis of Covid-19.

2. Patients who are willing to participate as subjects in the study by signing the informed content.

3. Criteria for Berlin to enter ARDS (moderate and severe) with or without a ventilator:

• PaO2 / FiO2: moderate 100-200

• PaO2 / FiO2: severe <100

4. One or more comorbid history

5. SOFA score

Exclusion Criteria:

1. The Covid19 patient has fibrosis (based on the results of the chest X-ray or CT chest)

2. ECOG 4 performance status, decreased irreversible consciousness, brain stem death.

3. Severe NYHA III / IV heart failure

4. Pregnant women