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

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.

Inclusion 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 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.

Exclusion 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.