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

• Status: Recruiting
• Trial end date: 2023-07-30
• Target enrollment: 0
• Participant gender: All

Summary

This randomized pilot phase I trial studies the side effects of donor bone marrow derived mesenchymal stem cells in controlling heart failure in patients with cardiomyopathy caused by anthracyclines. Donor bone marrow derived mesenchymal stem cells may help to control symptoms of heart failure and improve heart function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

1. Patients with LVEFmalignancy at any dose at any time without evidence of other causes of cardiomyopathy.

2. Age >/= 18 and

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. eGFR < 50 by Mayo or Cockcroft formula.

7. Presence of left ventricular thrombus as documented by echocardiography or left ventriculogram.

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. For patients not on anticoagulants, 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.

19. Automatic implantable cardioverter defibrillator (AICD) placement within the last 30 days.

20. AICD firing within the last 30 days.