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Trial With Mesenchymal Stromal Cells (MSCs) vs Standard of Care in Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT02962661
Recruitment Status : Not yet recruiting
First Posted : November 11, 2016
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
Texas Medical Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Objectives:

Primary Objective 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 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.


Condition or disease Intervention/treatment Phase
Other Forms of Heart Disease Biological: Intravenous Infusion of Human Mesenchymal Stem Cells (hMSCs) Other: Routine Heart Failure Medical Therapy Biological: Transendocardial Injections of Mesenchymal Stromal Cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 30, 2019
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous Infusion of MSCs

Participants receive 4 weekly doses of Mesenchymal Stromal Cells (MSCs) administered intravenously at a dose of 2 x 10^6 cells/Kg.

Participants treated with routine heart failure medical therapy as prescribed by physician.

Biological: Intravenous Infusion of Human Mesenchymal Stem Cells (hMSCs)
Intravenous Infusion of Mesenchymal Stromal Cells (MSCs) Group: 4 weekly doses of MSCs administered intravenously at a dose of 2 x 10^6 cells/Kg.
Other Names:
  • Intravenous Infusion of Mesenchymal Stromal Cells
  • MSC

Other: Routine Heart Failure Medical Therapy
Participants treated with routine heart failure medical therapy, Ace-inhibitors/Non-Selective beta blockers and when necessary diuretics/Aldosterone Inhibitors per institutionally defined standard of care.

Experimental: Transendocardial Injections of MSCs

Participants receive 15 injections of 0.2 ml Mesenchymal Stromal Cells (MSCs) at a total dose of 15 x 10^7 cells during one operative procedure.

Participants treated with routine heart failure medical therapy as prescribed by physician.

Other: Routine Heart Failure Medical Therapy
Participants treated with routine heart failure medical therapy, Ace-inhibitors/Non-Selective beta blockers and when necessary diuretics/Aldosterone Inhibitors per institutionally defined standard of care.

Biological: Transendocardial Injections of Mesenchymal Stromal Cells
Transendocardial Injections of Mesenchymal Stromal Cells (MSCs) Group: 15 injections of 0.2 ml MSCs at a total dose of 15 x 10^7 cells during one operative procedure using the MyoStarTM injection catheter (Biosense Webster, Inc.).
Other Name: MSC

Active Comparator: Standard of Care
Participants treated with routine heart failure medical therapy as prescribed by physician.
Other: Routine Heart Failure Medical Therapy
Participants treated with routine heart failure medical therapy, Ace-inhibitors/Non-Selective beta blockers and when necessary diuretics/Aldosterone Inhibitors per institutionally defined standard of care.




Primary Outcome Measures :
  1. Number of Adverse Events of Allogeneic Human Mesenchymal Stem Cells (hMSCs) Administered by Intravenous Infusion and Transendocardial Injection [ Time Frame: 6 months ]
    Adverse events include toxicity and death during 6 months after randomization.


Secondary Outcome Measures :
  1. Improvement in Left Ventricular Systolic Function (LVEF) Assessed by Left Ventricular Ejection Fraction [ Time Frame: 3, 6, and 12 months ]
  2. Left Ventricular End-Systolic and End-Diastolic Volumes Determined by Contrast-Enhanced 3-D Echography [ Time Frame: 3, 6, and 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 </= 80 years of Age.
  3. Documented NYHA class I, II and III.
  4. Patients with persistent LV dysfunction 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. eGFR < 50 by Mayo or Cockcroft formula.
  7. Presence of left ventricular thrombus as documented by echocardiography or left ventriculogram.
  8. Liver function tests > 3 x upper limit of normal.
  9. NYHA class IV heart failure.
  10. Inotropic dependence.
  11. Unstable or life-threatening arrhythmia.
  12. Coagulopathy INR > 1.5.
  13. Mechanical or Bioprosthetic heart valve.
  14. Cardiogenic shock.
  15. Breastfeeding and/or pregnant women.
  16. Autoimmune disorders on current immunosuppressive therapy.
  17. Active infection not responding to appropriate therapy as determined by Study Chair.
  18. Trastuzumab treatment within the last 3 months.
  19. Automatic implantable cardioverter defibrillator (AICD) placement within the last 30 days.
  20. AICD firing within the last 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962661


Contacts
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Contact: Amanda L. Olson, MD 713-745-1505 alolson@mdanderson.org

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact       alolson@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Texas Medical Center
Investigators
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Principal Investigator: Amanda L. Olson, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02962661     History of Changes
Other Study ID Numbers: 2015-0835
NCI-2016-01921 ( Registry Identifier: NCI CTRP )
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Other forms of heart disease
Left ventricular dysfunction
LV
Heart failure secondary to chemotherapy with anthracyclines
Human mesenchymal stem cells
hMSCs
Mesenchymal Stromal Cells
MSCs
Intravenous infusion
Transendocardial injection
Standard of care drugs for heart failure
Additional relevant MeSH terms:
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Heart Diseases
Cardiomyopathies
Cardiovascular Diseases