Adult Respiratory Distress Syndrome Clinical Trial
Official title:
A Pilot Study of Mesenchymal Stem Cells for Treatment of Acute Respiratory Distress Syndrome in Patients With Malignancies
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.
The MSCs:
MSCs are a type of stem cell that can be removed from bone marrow and grown into many
different cell types that can be used to treat cancer and other diseases. The MSCs used in
this study were collected from healthy donors and are stored and grown in a laboratory at MD
Anderson. The product you will receive is from a healthy donor that is not related to you.
MSC Administration:
If you are found to be eligible to take part in this study, you will receive MSCs by vein
over about 1-2 hours 1 time on Day 1.
Study Visits:
On Days 1 and 3:
- Blood (about 2 tablespoons) will be drawn for routine tests, to check your heart,
kidney, and liver function, and for biomarker testing.
- Blood (about ½ teaspoon) will be drawn to check the oxygen level in your blood.
On Days 14 and 30:
°Blood (about 2 tablespoons) will be drawn for routine tests, to check your heart, kidney,
and liver function, and for biomarker testing.
On Days 30 and 60:
°You will be checked for possible reactions to your treatment, including graft-versus-host
disease (GVHD - a reaction of the donor's immune cells against your body). This will be
checked by physical exam, by the doctor reviewing your side effects, and blood from standard
of care blood draws.
Length of Study:
Your participation on this study will end after the Day 60 study visit. You will be taken off
study early if you are not able to receive the MSC infusion(s), if intolerable side effects
occur, if the doctor thinks it is in your best interest, or if you are unable to follow study
directions.
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