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

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 (NCT02962661) is a Phase 1 interventional studying Cardiomyopathy and Heart Failure, sponsored by M.D. Anderson Cancer Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Cardiomyopathy, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 72 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Cardiomyopathy subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

M D Anderson Cancer Center

Houston, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT02962661), the sponsor (M.D. Anderson Cancer Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT02962661 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT02962661?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT02962661?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT02962661. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT02962661. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.