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

Description

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.

Conditions

Cardiomyopathy, Heart Failure, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Study Overview

Study Details

Study overview

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.

Randomized 3-Arm Trial With Standard of Care Alone vs Either Intravenous Infusion or Transendocardial Injection of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) Plus Standard of Care in Patients With Anthracycline-Associated Cardiomyopathy

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

Condition
Cardiomyopathy
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Amanda Olson, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2025-07-30