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Cell Therapy

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
Awards & highlights

Study 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.

Eligible Conditions
  • Acute Respiratory Distress Syndrome
  • Coronavirus Pneumonia

Timeline

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of grade 3-5 infusional toxicities and predefined hemodynamic or respiratory adverse events related to the infusion of MSC
Secondary outcome measures
Change in acute lung injury (ALI) score 2
Incidence of a reduction in one or more biomarkers of inflammation by day 7
Incidence of mortality
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mesenchymal Stromal CellsExperimental Treatment1 Intervention
Three fixed doses of MSC approximately 48 hours apart.
Group II: PlaceboPlacebo Group1 Intervention
Three fixed doses of placebo control approximately 48 hours apart.

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,616 Total Patients Enrolled
David Ingbar, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
1 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

Acute Respiratory Distress Syndrome Clinical Trial 2023: Mesenchymal stromal cells Highlights & Side Effects. Trial Name: NCT04466098 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Multiple Dosing of Mesenchymal Stromal Cells in Patients With ARDS (COVID-19)
2020. "Multiple Dosing of Mesenchymal Stromal Cells in Patients With ARDS (COVID-19)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04466098.
All > Covid
~2 spots leftby Apr 2025
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