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Stem Cell Therapy

MultiStem for COVID-19 Induced ARDS (MACoVIA Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Healios K.K.
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 day 60
Awards & highlights

Summary

This trial is testing a possible treatment for ARDS, which is a severe lung condition. The trial has two parts: an open-label lead-in (where everyone gets the treatment) followed by a double-blind, randomized, placebo-controlled phase (where some people get a placebo instead of the treatment).

Eligible Conditions
  • Acute Respiratory Distress Syndrome (ARDS)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.
Ventilator-Free Days
Secondary outcome measures
All-cause mortality
Ranked hierarchical composite outcome of alive and ventilator-free
Ventilator-free days

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MultiStemExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MultiStem
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Healios K.K.Lead Sponsor
12 Previous Clinical Trials
1,070 Total Patients Enrolled
Athersys, IncLead Sponsor
10 Previous Clinical Trials
829 Total Patients Enrolled
Anthony Ting, PhDStudy DirectorAthersys, Inc

Media Library

MultiStem (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04367077 — Phase 2 & 3
Acute Respiratory Distress Syndrome Research Study Groups: MultiStem, Placebo
Acute Respiratory Distress Syndrome Clinical Trial 2023: MultiStem Highlights & Side Effects. Trial Name: NCT04367077 — Phase 2 & 3
MultiStem (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04367077 — Phase 2 & 3
~77 spots leftby Jul 2025