Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines

Launched by M.D. ANDERSON CANCER CENTER · Nov 10, 2016

Keywords

ClinConnect Summary

This clinical trial is investigating whether special cells derived from donor bone marrow, called mesenchymal stem cells, can help improve heart function and control symptoms of heart failure in patients who have heart problems (known as cardiomyopathy) caused by a type of cancer treatment called anthracyclines. This is a phase I trial, meaning it's an early-stage study aimed at understanding the safety and effects of these cells in patients aged 18 to 80 who have specific heart conditions, including a reduced heart function measured by a test called LVEF. Patients with severe heart failure or other serious heart issues may not be eligible to participate.

If you or a loved one qualifies for this trial, you can expect to receive the stem cells through an injection, and the study will monitor any side effects and improvements in heart health. Participants will also need to have already received standard heart failure treatments. It's important to note that this trial is currently recruiting participants, and anyone interested will need to give informed consent, ensuring they understand the study and its potential risks and benefits.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with LVEF \</= 40% documented from treatment with anthracyclines for any malignancy at any dose at any time without evidence of other causes of cardiomyopathy.
• • 2. Age \>/= 18 and \</= 90 years of age. English and non-English speaking patients are eligible.
• • 3. Documented NYHA class I, II and III.
• • 4. For patients who have received trastuzumab: Persistent LV dysfunction must be present 90 days after discontinuation of trastuzumab.
• • 5. Able to perform 6 minute walk test.
• • 6. Been treated with appropriate maximal medical therapy for heart failure.
• • 7. Patient or legally authorized representative able to sign informed consent.
• 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 enrollment.
• • 5. History of Infiltrative cardiomyopathy or restrictive cardiomyopathy.
• • 6. Presence of left ventricular thrombus as documented by echocardiography or left ventriculogram.
• • 7. Liver function tests \> 3 x upper limit of normal.
• • 8. NYHA class IV heart failure.
• • 9. Inotropic dependence.
• • 10. Unstable or life-threatening arrhythmia.
• • 11. For patients not on anticoagulants, INR\>1.5
• • 12. Mechanical or Bioprosthetic heart valve.
• • 13. Cardiogenic shock.
• • 14. Breastfeeding and/or pregnant women.
• • 15. Autoimmune disorders on current immunosuppressive therapy.
• • 16. Active infection not responding to appropriate therapy as determined by Study Chair.
• • 17. Trastuzumab treatment within the last 3 months.
• • 18. Automatic implantable cardioverter defibrillator (AICD) placement within the last 30 days.
• • 19. AICD firing within the last 30 days.