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

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ClinicalTrials.gov Identifier: NCT02804945
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
Katz Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Blood And Marrow Transplantation Adult Respiratory Distress Syndrome Biological: Mesenchymal Stem Cells (MSCs) Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Mesenchymal Stem Cells for Treatment of Acute Respiratory Distress Syndrome in Patients With Malignancies
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020


Arm Intervention/treatment
Experimental: Mesenchymal Stem Cells

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.

Biological: Mesenchymal Stem Cells (MSCs)
Participants receive a maximum dose of 3 x 10^6 cell/Kg by vein one time on Day 1.




Primary Outcome Measures :
  1. Adverse Events of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD) [ Time Frame: 30 days ]
    Adverse Events determined by CTCAE version 4.


Secondary Outcome Measures :
  1. Clinical Improvement of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD) [ Time Frame: Baseline, 7 days and 30 days ]
    Clinical improvement defined as decreased mechanical ventilation after the mesenchymal stem cell (MSC) infusion.

  2. Improvement in PF or S/F Ratio of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD) [ Time Frame: Baseline, 7 days and 30 days ]
    An improvement in PF or S/F ratio defined as decreased mechanical ventilatory requirement.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 </= 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804945


Contacts
Contact: Amanda L. Olson, MD 713-792-8750 CR_Study_Registration@mdanderson.org
Contact: Clinical Research Operations MD Anderson Cancer Center 713-792-7734 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Katz Foundation
Investigators
Principal Investigator: Amanda L. Olson, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02804945     History of Changes
Other Study ID Numbers: 2015-0327
NCI-2016-01184 ( Other Identifier: NCI CTRP )
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Blood And Marrow Transplantation
Adult Respiratory Distress Syndrome
ARDS
Allogeneic human mesenchymal stem cells
hMSCs
Placebo
Plasma-Lyte A solution
Standard of Care
Recent onset pulmonary toxicity

Additional relevant MeSH terms:
Pathologic Processes
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury