Mesenchymal Stromal Cells for ARDS (COVID-19)

Phase 2

Waitlist Available

Led By David Ingbar, MD

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on the day of screening and on days 3, 7 and 14 after first infusion

Summary

This trial is testing whether mesenchymal stromal cells (MSC) can help treat patients with SARS-CoV-2 associated Acute Respiratory Distress Syndrome (ARDS). Patients will be randomly assigned to receive either MSC or a placebo, with two patients receiving MSC for every one receiving the placebo.

Who is the study for?

This trial is for adults aged 18-80 with moderate to severe ARDS due to COVID-19, who have been on a ventilator for less than 48 hours. They must have certain levels of organ function and can't be on continuous dialysis or other investigational treatments for ARDS. Pregnant or breastfeeding women and those with significant heart, liver, kidney diseases, or an allergy to MSC components are excluded.

What is being tested?

The trial is testing the safety and potential effectiveness of multiple doses of mesenchymal stromal cells (MSC) compared to a placebo in patients with ARDS from COVID-19. Participants will be randomly assigned in a 2:1 ratio to receive either MSCs or placebo.

What are the potential side effects?

Potential side effects may include reactions related to infusion such as fever or chills, immune system responses like allergic reactions, and possible impacts on organ functions which will be closely monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on the day of screening and on days 3, 7 and 14 after first infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on the day of screening and on days 3, 7 and 14 after first infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and on the day of screening and on days 3, 7 and 14 after first infusion for reporting.