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

Completed · Phase 1

Conditions studied: Blood And Marrow Transplantation, Adult Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT02804945

Run by

M.D. Anderson Cancer Center

People needed

20

Starts

2017-02-24

Expected to finish

2019-06-13

Last updated by the study team

2020-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients age >/=18 years.
• Treated with appropriate maximal medical therapy for pulmonary toxicity.
• Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
• Patient or legally appropriate proxy must be able to understand study instructions and sign consent.

You may not qualify if…

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

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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