Mesenchymal Stem Cells (MSCs) for Treatment of Acute Respiratory Distress Syndrome (ARD) in Patients With Malignancies

Study summary

The goal of this clinical research study is to learn about the safety of giving mesenchymal stem cells (MSCs) to patients who have ARDS. Researchers also want to learn if these cells can help control ARDS when given with drugs that are routinely used to treat ARDS. In this study, participants will receive 1 infusion of MSCs. This is an investigational study. MSC infusions for the treatment of ARDS is investigational. Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMesenchymal Stem Cells (MSCs)

The study team can explain what participation involves.

Who it may be forBlood And Marrow Transplantation · Adult Respiratory Distress Syndrome

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 10, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
Interventions being studied: Biological: Mesenchymal Stem Cells (MSCs)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. ARDS characterized by hypoxemia and bilateral radiographic opacities not fully explained by cardiac failure or fluid overload as judged by the treating physician using all available data. Moderate ARDS includes patients with malignancies with the previous presentation and a P/F ratio \</= 200 or SF ratio of \</= 214. The duration of the hypoxemia criterion and the radiograph criterion must be within 10 days of the time of enrollment. 2. Patients age \>/=18 years. 3. Treated with appropriate maximal medical therapy for pulmonary toxicity. 4. Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. 5. Patient or legally appropriate proxy must be able to understand study instructions and sign consent.

Reasons someone may not be able to joinExclusion criteria

1. Unstable ventricular tachycardia or fibrillation. 2. Moribund patients not expected to survive up to 48 hours. 3. Patients with ARDS resulting from trauma. 4. Patients with documented deep venous thrombosis or pulmonary embolism within the past 3 months. 5. Patients with severe chronic liver disease (Childs-Pugh score \> 10). 6. Patients with previous solid organ transplant. 7. Pregnant and/or lactating women.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 10, 2020. Always confirm current availability with the study team.

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