Houston, Texas 77030


Purpose:

The goal of this clinical research study is to learn if adding mesenchymal stem cells (MSCs) to standard of care drugs can help control heart failure that may have been caused by anthracyclines (a type of chemotherapy drug used in cancer treatment). The safety of the MSCs will also be studied. 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, such as heart failure. The MSCs used in this study were collected from healthy donors and are stored and grown in a laboratory at MD Anderson.


Study summary:

Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. - If you are in Group 1, you will receive MSCs and standard of care drugs for heart failure. - If you are in Group 2, you will only receive standard of care drugs for heart failure. You will have a 2 in 3 chance of being assigned to Group 1 and a 1 in 3 chance of being assigned to Group 2. Study Drug Administration: If you are in Group 1, you will receive MSCs by vein over about 10-20 minutes 1 time each week for 4 weeks in the outpatient clinic. You will remain in the clinic for up to 6 hours after each MSC infusion so the study staff may check you for any side effects. Both groups will also receive standard of care drugs for heart failure. The study doctor will tell you which drugs you are taking, their risks, and when you should take them. Study Visits: On Days 1, 14, 21, and 28 (+/- 5 days), if you are in Group 1, blood (about 4 tablespoons) will be drawn for routine tests and to check your heart and liver function. One (1) time each month during Months 2-6, all participants: - You will have a physical exam. - Blood (about 4 tablespoons) will be drawn for routine tests and to check your heart and liver function. At Months 3 and 6, this blood will also be used for biomarker testing. - At Months 1, 3, and 6 only, you will have an EKG and ECHO. - At Months 3 and 6 only, you will perform physical tests, including walking for about 6 minutes. At Month 12, you will have a physical exam, EKG, and ECHO. Length of Study: If you are in Group 1, you will be able to receive up to 4 infusions of MSCs. You will no longer be able to receive the MSCs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your active participation in this study will be over after Month 12. This is an investigational study. MSCs are not FDA-approved or commercially available. They are being used for research purposes only. The study doctor can explain how they are designed to work. Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.


Criteria:

Inclusion Criteria: 1. Patients with LVEF </= 40% from treatment with anthracyclines for all malignancies at any dose without evidence of other causes of cardiomyopathy. 2. 18-80 years of age. 3. Documented NYHA class I, II and III. 4. Been treated with appropriate maximal medical therapy for heart failure. 5. Able to perform 6 minute walk test. 6. Patient or legally authorized representative able to sign informed consent. 7. Patients with persistent LV dysfunction 90 days after discontinuation of trastuzumab. Exclusion Criteria: 1. Evidence of Ischemic Heart Disease as determined by study Cardiologist. 2. Significant Valvular Disease. (AS with AVA <1.5 and severe AR and MR). 3. History of Familial Cardiomyopathy. 4. Recent documented myocarditis within 2 months of consent. 5. History of Infiltrative cardiomyopathy or restrictive cardiomyopathy. 6. eGFR < 50 by Mayo or Cockcroft formula. 7. Creatinine clearance of <50 ml/min. 8. Liver function tests > 3 x upper limit of normal. 9. NYHA class IV heart failure. 10. Inotropic dependence. 11. Unstable or life-threatening arrhythmia. 12. Coagulopathy INR > 1.5. 13. Mechanical or Bioprosthetic heart valve. 14. Cardiogenic shock. 15. Breastfeeding and/or pregnant women. 16. Autoimmune disorders on current immunosuppressive therapy. 17. Active infection not responding to appropriate therapy as determined by Study Chair. 18. Trastuzumab treatment within the last 3 months.


NCT ID:

NCT02408432


Primary Contact:

Principal Investigator
Amanda L. Olson, MD
M.D. Anderson Cancer Center

Amanda L. Olson, MD
Phone: 713-792-8750


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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