RecruitingPhase 1NCT02962661

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

72 participants

Start Date

Jul 18, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether stem cells donated from another person's bone marrow can help improve heart function in patients whose hearts were weakened by certain cancer chemotherapy drugs called anthracyclines. **You may be eligible if...** - Your heart pumping function is at or below 40% (measured by a heart scan) and this was caused by anthracycline chemotherapy for any type of cancer - You are between 18 and 90 years old - You speak English or another language (non-English speakers are welcome) - Your heart failure symptoms are mild to moderate (NYHA class I, II, or III) - If you also received a drug called trastuzumab (Herceptin), your heart problems must have continued for at least 90 days after stopping it - You can complete a 6-minute walking test **You may NOT be eligible if...** - Your heart weakness was caused by something other than chemotherapy - Your heart failure is severe (NYHA class IV) - You have other serious health conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBest Practice

Given standard of care

OTHERLaboratory Biomarker Analysis

Correlative studies

DRUGMesenchymal Stem Cell Transplantation

Given IV

DRUGMesenchymal Stem Cell Transplantation

Given transendocardially


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT02962661


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