Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
NCT ID: NCT02962661
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2020-07-18
2026-07-30
Brief Summary
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Detailed Description
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I. To demonstrate the safety of allogeneic human mesenchymal stem cells (hMSCs) administered by intravenous infusion and transendocardial injection 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 and transendocardial injection 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 3 arms.
ARM I: Patients receive hMSCs intravenously (IV) over 10-20 minutes on days 1, 14, 21, and 28 and standard of care treatment for heart failure in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive hMSCs transendocardially for a total of 15 injections and standard of care treatment for heart failure in the absence of disease progression or unacceptable toxicity.
ARM III: Patients receive standard of care treatment for heart failure.
After completion of study treatment, patients are followed up periodically.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (hMSCs IV)
Patients receive hMSCs IV over 10-20 minutes on days 1, 14, 21, and 28 and standard of care treatment for heart failure in the absence of disease progression or unacceptable toxicity.
Best Practice
Given standard of care
Laboratory Biomarker Analysis
Correlative studies
Mesenchymal Stem Cell Transplantation
Given IV
Arm II (hMSCs transendocardially)
Patients receive hMSCs transendocardially for a total of 15 injections and standard of care treatment for heart failure in the absence of disease progression or unacceptable toxicity.
Best Practice
Given standard of care
Laboratory Biomarker Analysis
Correlative studies
Mesenchymal Stem Cell Transplantation
Given transendocardially
Arm III (standard of care)
Patients receive standard of care treatment for heart failure.
Best Practice
Given standard of care
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Best Practice
Given standard of care
Laboratory Biomarker Analysis
Correlative studies
Mesenchymal Stem Cell Transplantation
Given IV
Mesenchymal Stem Cell Transplantation
Given transendocardially
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Amanda Olson, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2016-01921
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0835
Identifier Type: OTHER
Identifier Source: secondary_id
2015-0835
Identifier Type: -
Identifier Source: org_study_id
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