Using donor stem cells to treat heart failure from chemotherapy

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

This study is testing if using donor stem cells can help people with heart failure caused by chemotherapy feel better and improve their heart function.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: trastuzumab, chemotherapy
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT02962661 on ClinicalTrials.gov

What this trial studies

This pilot phase I trial investigates the safety and efficacy of donor bone marrow derived mesenchymal stem cells (hMSCs) in patients suffering from heart failure due to cardiomyopathy caused by anthracyclines. Participants are randomized into three groups: one receiving hMSCs intravenously, another receiving hMSCs via transendocardial injection, and a control group receiving standard heart failure treatment. The study aims to assess the potential of hMSCs to improve heart function and alleviate symptoms of heart failure. Patients will be monitored for side effects and overall heart function throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with left ventricular ejection fraction of 40% or less due to anthracycline treatment.

Not a fit: Patients with ischemic heart disease, significant valvular disease, or other specific cardiomyopathies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for patients with chemotherapy-induced heart failure.

How similar studies have performed: While the use of stem cells in cardiac applications is being explored, this specific approach is novel and has not been extensively tested in similar contexts.

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.

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Amanda Olson, MD — M.D. Anderson Cancer Center
• Study coordinator: Amanda Olson, MD

Conditions Cardiomyopathy; Heart Failure; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm