NCT02962661 · M.D. Anderson Cancer Center
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
What this study is about
This randomly assigned 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.
View original scientific 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.
Interventions
OTHER
Best Practice
Given standard of care
OTHER
Laboratory Biomarker Analysis
Correlative studies
DRUG
Mesenchymal Stem Cell Transplantation
Given IV
DRUG
Mesenchymal Stem Cell Transplantation
Given transendocardially
Primary outcome measures
Incidence of adverse events
Time frame: Up to 6 months
Statistical analyses of safety will be descriptive.
Change in left ventricular ejection fraction (LVEF)
Time frame: Baseline to 6 months
The comparison will be between the two groups of patients.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Age \>/= 18 and \</= 90 years of age. English and non-English speaking patients are eligible.
- Documented NYHA class I, II and III.
- For patients who have received trastuzumab: Persistent LV dysfunction must be present 90 days after discontinuation of trastuzumab.
- Able to perform 6 minute walk test.
- Been treated with appropriate maximal medical therapy for heart failure.
- Patient or legally authorized representative able to sign informed consent.
Exclusion criteria
- Evidence of Ischemic Heart Disease as determined by study cardiologist.
- Significant Valvular Disease. (AS with AVA \<1.5 and severe AR and MR)
- History of Familial Cardiomyopathy.
- Recent documented myocarditis within 2 months of enrollment.
- History of Infiltrative cardiomyopathy or restrictive cardiomyopathy.
- Presence of left ventricular thrombus as documented by echocardiography or left ventriculogram.
- Liver function tests \> 3 x upper limit of normal.
- NYHA class IV heart failure.
- Inotropic dependence.
- Unstable or life-threatening arrhythmia.
- For patients not on anticoagulants, INR\>1.5
- Mechanical or Bioprosthetic heart valve.
- Cardiogenic shock.
- Breastfeeding and/or pregnant women.
- Autoimmune disorders on current immunosuppressive therapy.
- Active infection not responding to appropriate therapy as determined by Study Chair.
- Trastuzumab treatment within the last 3 months.
- Automatic implantable cardioverter defibrillator (AICD) placement within the last 30 days.
- AICD firing within the last 30 days.
Where
- Houston, Texas
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations