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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
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 moreSTAT 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
912 Previous Clinical Trials
323,602 Total Patients Enrolled
3 Trials studying Respiratory Distress Syndrome
517 Patients Enrolled for Respiratory Distress Syndrome
United States Department of DefenseFED
867 Previous Clinical Trials
327,242 Total Patients Enrolled
3 Trials studying Respiratory Distress Syndrome
1,313 Patients Enrolled for Respiratory Distress Syndrome
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Cell Reconstitution Media
- Group 2: Human Mesenchymal Stromal Cells
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