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Plasma-lyte 148

Participants receive Mesenchymal Stem Cells (MSCs) for adult respiratory distress syndrome (ARDS).

Participants receive a maximum dose of 3 x 10\^6 cell/Kg by vein one time on Day 1.

Participants receive a maximum dose of 3 x 10\^6 cell/Kg by vein one time on Day 1.

Mesenchymal Stem Cells (MSCs)

Amanda L. Olson, MD

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.

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

A Pilot Study of Mesenchymal Stem Cells for Treatment of Acute Respiratory Distress Syndrome in Patients With Malignancies

Adverse Events determined by CTCAE version 4.

Clinical improvement defined as decreased mechanical ventilation after the mesenchymal stem cell (MSC) infusion.

An improvement in PF or S/F ratio defined as decreased mechanical ventilatory requirement.

Katz Foundation

M.D. Anderson Cancer Center

Neoplasms

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

This will be a dose escalation study. The first 3 subjects will receive a single dose of 1 x 10\^6 cells/kg or a maximum dose of 1 x 10\^8 total cells IV.

The remaining subjects will receive a single dose of 2 x 10\^6 cells/kg or a maximum dose of 2 x 10\^8 total cells IV.

This will be a dose escalation study. The first 3 subjects will receive a single dose of 1 x 10\^6 cells/kg or a maximum dose of 1 x 10\^8 total cells IV 4 days prior to undergoing a planned prostatectomy.

The remaining subjects will receive a single dose of 2 x 10\^6 cells/kg or a maximum dose of 2 x 10\^8 total cells IV either 4 or 6 days prior to the planned prostatectomy, and if additional doses of MSCs are able to be expanded, up to 6 additional men will be enrolled with a plan to treat them 8 days prior to the prostatectomy.

Allogeneic Human Mesenchymal Stem Cells

Samuel Denmeade, MD

The objective of this study is to determine if systemically infused allogeneic bone marrow derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized adenocarcinoma of the prostate that are planning to undergo a prostatectomy. Investigators plan to systemically infuse MSCs 4, 6 or 8 days prior to enrolled subjects' planned prostatectomies. Investigators will then quantify the relative amount of donor MSC DNA to recipient DNA present in patients' explanted prostate specimens. This will be accomplished via BEAMing digital PCR. This trial will provide the foundation for future studies aimed at engineering MSCs to deliver a toxin to sites of metastatic prostate cancer.

Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer

A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer

Allogeneic MSCs will be quantified through tissue BEAMing and the percent of MSCs per total cell number will be calculated.

The percentage of screened subjects that agreed to receive a pre-prostatectomy infusion of MSCs at the pre-specified time point and subsequently undergo a radical prostatectomy.

Proportion of MSC to recipient DNA is calculated by number of MSCs over the number of recipient DNA (\[number of MSC\]/\[number of recipient DNA\]) in the peripheral blood.

Proportion of MSC to recipient DNA is calculated by number of MSCs over the number of recipient DNA (\[number of MSC\]/\[number of recipient DNA\]) in the seminal vesicle.

The SHIM is a measure of sexual function with a score ranging from 1 (severe erectile dysfunction) to 25 (normal function). Participants are required to have a score of \>=17 to be eligible for the study.

Change in total urinary function score (possible score range from 5-51) on the EPIC survey.

Change in total bowel habits score (possible score range from 8-62) on the EPIC survey.

Change in total sexual function score (possible score range from 10-61) on the EPIC survey.

Change in total hormonal function score (possible score range from 5-49) on the EPIC survey.

Change in overall satisfaction score (possible score range from 1-5) on the EPIC survey with a higher score reflecting higher overall satisfaction.

Number of participants experiencing adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010.

Number of participants experiencing serious adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010.

Number of participants experiencing treatment-related adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mesenchymal Stem Cells (MSCs) for Treatment of Acute Respiratory Distress Syndrome (ARD) in Patients With Malignancies	NCT02804945	Blood And Marro... Adult Respirato...	Mesenchymal Ste...	18 Years -	M.D. Anderson Cancer Center
Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer	NCT01983709	Prostate Cancer	Allogeneic Huma...	18 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for allogeneic human mesenchymal stem cells