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NCT Number: NCT02408432

Bone Marrow Derived Mesenchymal Stem Cells in Improving Heart Function in Patients With Heart Failure Caused by Anthracyclines

This randomized pilot phase I trial studies the side effects and best method of delivery of bone marrow derived mesenchymal stem cells (MSCs) in improving heart function in patients with heart failure caused by anthracyclines (a type of chemotherapy drug used in cancer treatment). MSCs are a type of stem cell that can be removed from bone marrow and grown into many different cell types that can be used to treat cancer and other diseases, such as heart failure. Bone marrow derived MSCs may promote heart muscle cells repair and lead to reverse remodeling and ultimately improve heart function and decrease morbidity and mortality from progression to advanced heart failure.

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Key information

Conditions

Cardiomyopathy Cardiomyopathies Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVE:

I. To demonstrate the safety of allogeneic human mesenchymal stem cells (hMSCs) administered by intravenous infusion in patients with left ventricular (LV) dysfunction and heart failure secondary to chemotherapy with anthracyclines.

SECONDARY OBJECTIVE:

I. To demonstrate the efficacy of allogeneic hMSCs administered by intravenous infusion in patients with left ventricular dysfunction (left ventricular ejection fraction [LVEF] < 40%) and heart failure secondary to treatment with anthracyclines.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive allogeneic hMSCs intravenously (IV) over 10-20 minutes once weekly for 4 weeks and standard of care drugs for heart failure.

ARM II: Patients receive only standard of care drugs for heart failure.

After completion of study treatment, patients are followed up monthly for 6 months and then at 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with LVEF =< 40% from treatment with anthracyclines for all malignancies at any dose at any time without evidence of other causes of cardiomyopathy
  • Documented New York Heart Association (NYHA) class I, II and III
  • Been treated with appropriate maximal medical therapy for heart failure
  • Able to perform 6 minute walk test
  • Patient or legally authorized representative able to sign informed consent
  • Patients with persistent LV dysfunction 90 days after discontinuation of trastuzumab

Exclusion criteria

  • Evidence of ischemic heart disease as determined by study cardiologist
  • Significant valvular disease; (aortic stenosis [AS] with aortic valve area [AVA] < 1.5 and severe aortic regurgitation [AR] and mitral regurgitation [MR])
  • History of familial cardiomyopathy
  • Recent documented myocarditis within 2 months of consent
  • History of infiltrative cardiomyopathy or restrictive cardiomyopathy
  • Epidermal growth factor receptor (eGFR) < 50 by Mayo or Cockcroft formula
  • Liver function tests > 3 x upper limit of normal
  • NYHA class IV heart failure
  • Inotropic dependence
  • Unstable or life-threatening arrhythmia
  • Coagulopathy international normalized ratio (INR) > 1.5
  • Mechanical or bioprosthetic heart valve
  • Cardiogenic shock
  • Breast feeding 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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Standard of care

Other

Undergo mesenchymal stem cell infusion

Mesenchymal Stem Cell Transplantation

Drug

Undergo mesenchymal stem cell infusion

Primary outcomes

  1. Incidence of adverse events of intravenous injection of human mesenchymal stem cells (hMSCs) in patients with recent onset left ventricular systolic dysfunction from anthracyclines

    Time frame: Up to 6 months

    Statistical analyses of safety will be descriptive. In particular, will provide a table of adverse events.

Secondary outcomes

  1. Change in improvement in left ventricular systolic function by 7 points

    Time frame: Baseline up to 6 months

    Change from baseline left ventricular ejection fraction (LVEF) at 6 months after randomization, expressed as a percentage. The comparison will be between the two groups of patients.

  2. Development of acute heart failure decompensation

    Time frame: Up to 6 months

    As regards statistical analyses, the results of the trial will be displayed in table format. Will provide confidence intervals of the differences in change from baseline between investigational and control groups. These intervals and the associate p-values will be calculated using two-sample t-tests, with no adjustments for multiple comparisons.

  3. Emergency center visits for heart failure

    Time frame: Up to 6 months

    As regards statistical analyses, the results of the trial will be displayed in table format. Will provide confidence intervals of the differences in change from baseline between investigational and control groups. These intervals and the associate p-values will be calculated using two-sample t-tests, with no adjustments for multiple comparisons.

  4. Need for new pacemaker/automatic implantable cardioverter defibrillator

    Time frame: Up to 6 months

    As regards statistical analyses, the results of the trial will be displayed in table format. Will provide confidence intervals of the differences in change from baseline between investigational and control groups. These intervals and the associate p-values will be calculated using two-sample t-tests, with no adjustments for multiple comparisons.

  5. New onset arrhythmias

    Time frame: Up to 6 months

    As regards statistical analyses, the results of the trial will be displayed in table format. Will provide confidence intervals of the differences in change from baseline between investigational and control groups. These intervals and the associate p-values will be calculated using two-sample t-tests, with no adjustments for multiple comparisons.

  6. Sudden cardiac death

    Time frame: Up to 6 months

    As regards statistical analyses, the results of the trial will be displayed in table format. Will provide confidence intervals of the differences in change from baseline between investigational and control groups. These intervals and the associate p-values will be calculated using two-sample t-tests, with no adjustments for multiple comparisons.

  7. Acute pulmonary edema

    Time frame: Up to 6 months

    As regards statistical analyses, the results of the trial will be displayed in table format. Will provide confidence intervals of the differences in change from baseline between investigational and control groups. These intervals and the associate p-values will be calculated using two-sample t-tests, with no adjustments for multiple comparisons.

  8. Asymptomatic decrease in left ventricular ejection fraction (LVEF) of > 10%

    Time frame: Baseline to up to 6 months

    As regards statistical analyses, the results of the trial will be displayed in table format. Will provide confidence intervals of the differences in change from baseline between investigational and control groups. These intervals and the associate p-values will be calculated using two-sample t-tests, with no adjustments for multiple comparisons.

  9. Heart failure admission

    Time frame: Up to 6 months

    As regards statistical analyses, the results of the trial will be displayed in table format. Will provide confidence intervals of the differences in change from baseline between investigational and control groups. These intervals and the associate p-values will be calculated using two-sample t-tests, with no adjustments for multiple comparisons.

  10. Progression free survival

    Time frame: Up to 12 months

    As regards statistical analyses, the results of the trial will be displayed in table format. Will provide confidence intervals of the differences in change from baseline between investigational and control groups. These intervals and the associate p-values will be calculated using two-sample t-tests, with no adjustments for multiple comparisons.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Intravenous Administration of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) in Patients With Recent Onset Anthracycline-Associated Cardiomyopathy

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 3, 2015
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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