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Cell Therapy

Mesenchymal Stromal Cells for Acute Respiratory Distress Syndrome (STAT Trial)

Phase 2
Waitlist Available
Led By Michael Matthay, MD
Research Sponsored by Michael A. Matthay
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 72 hours
Awards & highlights

STAT Trial Summary

This trial is testing a possible treatment for Acute Respiratory Distress Syndrome (ARDS) by infusion of hMSCs. The study builds on earlier phases of testing for safety and efficacy.

Who is the study for?
This trial is for adults with Acute Respiratory Distress Syndrome (ARDS) who need positive pressure ventilation, have specific blood oxygen levels, and show certain signs on chest imaging. It's not for those recently in ICU over 14 days, pregnant or breastfeeding women, people with severe heart or brain conditions, chronic respiratory disease requiring home oxygen, extensive burns, some cancers within the last 2 years, or expected high short-term mortality.Check my eligibility
What is being tested?
The study tests a single infusion of Human Mesenchymal Stromal Cells (hMSCs) derived from bone marrow to see if they're safe and effective for ARDS treatment. This follows earlier pilot studies and involves randomly assigning patients to receive either hMSCs or a placebo without knowing which one they get.See study design
What are the potential side effects?
While the trial primarily assesses safety and efficacy of hMSCs infusion for ARDS patients, potential side effects are likely similar to other cell therapies including immune reactions, infection risk increase due to immunomodulation effects of stem cells.

STAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in oxygenation index (OI)
Secondary outcome measures
Acute Lung Injury Score (LIS)
All-cause hospital mortality
Chest radiograph assessment of pulmonary edema (RALE score)
+21 more

STAT Trial Design

2Treatment groups
Experimental Treatment
Group I: Human Mesenchymal Stromal CellsExperimental Treatment1 Intervention
A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes.
Group II: Cell Reconstitution MediaExperimental Treatment1 Intervention
A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cell Reconstitution Media
2019
Completed Phase 2
~120
Human Umbilical Cord Mesenchymal Stem Cells
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Harborview Injury Prevention and Research CenterOTHER
11 Previous Clinical Trials
14,389 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
903 Previous Clinical Trials
320,857 Total Patients Enrolled
3 Trials studying Respiratory Distress Syndrome
517 Patients Enrolled for Respiratory Distress Syndrome
United States Department of DefenseFED
861 Previous Clinical Trials
227,074 Total Patients Enrolled
3 Trials studying Respiratory Distress Syndrome
1,313 Patients Enrolled for Respiratory Distress Syndrome

Media Library

Respiratory Distress Syndrome Research Study Groups: Cell Reconstitution Media, Human Mesenchymal Stromal Cells

Frequently Asked Questions

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

In how many different hospitals is this research being conducted today?

"The 8 trial sites for this experiment are: Oregon Health & Science University, Portland; University of California San Francisco; University of California Davis Medical Center, Sacramento; and 7 other locations."

Answered by AI

Can patients still sign up for this research trial?

"Yes, as indicated on clinicaltrials.gov, this trial is recruiting patients. The posting date was 11/26/2019 and the most recent edit was on 9/13/2022. There are 7 sites involved in the study and a total of 120 participants are needed."

Answered by AI

How many human subjects are included in this experiment?

"The trial needs one hundred and twenty participants that fall under the given inclusion criteria. These potential patients can go to various locations, such as Oregon Health & Science University in Portland or University of California San Francisco in San Francisco."

Answered by AI

Are Human Mesenchymal Stromal Cells accepted by the FDA?

"While there is some evidence that Human Mesenchymal Stromal Cells are safe, as this is only a Phase 2 trial, more data supporting efficacy is needed. Consequently, our team has given it a score of 2."

Answered by AI

What are other ways that Human Mesenchymal Stromal Cells have been researched in the past?

"Human Mesenchymal Stromal Cells were first investigated in 2013 by U.O. Nefrologia e Dialisi. As of now, 29 trials have been completed with 37 more currently ongoing. The majority of these are located in Portland, Oregon."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome
Michael A. Matthay 2019. "Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03818854.
~22 spots leftby Apr 2025
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