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Stem Cell Therapy

MultiStem for COVID-19 Induced ARDS (MACoVIA Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Athersys, Inc
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

MACoVIA Trial 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)

MACoVIA Trial 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

MACoVIA 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?

Athersys, IncLead Sponsor
10 Previous Clinical Trials
829 Total Patients Enrolled
Anthony Ting, PhDStudy DirectorAthersys, Inc
Eric Jenkins, MDStudy 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing or completed research projects that are similar to this one?

"4 clinical trials are studying MultiStem with 3 of them being in Phase 3. The primary location for these studies is in Phoenix, Arizona, however, there are a total of 32 medical centres running these trials."

Answered by AI

Who is this clinical study looking for as participants?

"This study is looking for 400 individuals aged 18 to 89 that currently suffer from respiratory distress syndrome, newborn. Patients must also meet the following additional criteria: a recent diagnosis of moderate to severe ARDS according to the Berlin criteria, the need for an endotracheal or tracheal tube, and evidence of pneumonia or a severe localized or systemic infection."

Answered by AI

Have these treatments been tested before in a clinical setting?

"There are currently 4 ongoing studies for MultiStem in 22 cities and 3 countries. The first study was completed in 2017 and involved 220 patients. It reached Phase 2 & 3 in the drug approval process. Since then, there have been 18,243 trials conducted."

Answered by AI

Does this test require participants to be a certain age?

"According to the eligibility requirements listed on clinicaltrials.gov, people aged 18 to 89 can apply to participate in this trial. In contrast, there are 153 trials for minors and 1042 for senior citizens."

Answered by AI

Are we recruiting test subjects for this experiment currently?

"The information available on clinicaltrials.gov indicates that this clinical trial is actively recruiting patients. This study was first posted on 4/28/2020, and the most recent update was on 9/7/2021. The study is aiming to enroll 400 participants from 4 different sites."

Answered by AI

Who else is applying?

What site did they apply to?
Athersys Investigational Site 107
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
2020. "MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04367077.
All > Covid
~81 spots leftby Apr 2025
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