- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408432
Bone Marrow Derived Mesenchymal Stem Cells in Improving Heart Function in Patients With Heart Failure Caused by Anthracyclines
Intravenous Administration of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) in Patients With Recent Onset Anthracycline-Associated Cardiomyopathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (hMSCs)
Patients receive allogeneic hMSCs IV over 10-20 minutes once weekly for 4 weeks and standard of care drugs for heart failure.
|
Correlative studies
Undergo mesenchymal stem cell infusion
Undergo mesenchymal stem cell infusion
|
Active Comparator: Arm II (standard of care drugs)
Patients receive only standard of care drugs for heart failure.
|
Correlative studies
Undergo mesenchymal stem cell infusion
Undergo mesenchymal stem cell infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Baseline to up to 6 months
|
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.
|
Up to 6 months
|
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.
|
Up to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-0519 (Other Identifier: M D Anderson Cancer Center)
- NCI-2015-00969 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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