RECRUITING

Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines

Conditions

Cardiomyopathy Heart Failure Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-07-18

Study Completion:2025-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02962661

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 \</= 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.	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. 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.

Inclusion Criteria

Exclusion 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 \</= 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.

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. 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.

Contacts and Locations

Study Contact

Amanda Olson, MD

CONTACT

713-745-3055

alolson@mdanderson.org

Principal Investigator

Amanda Olson, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Amanda Olson, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-18

Study Completion Date2025-07-30

Study Record Updates

Study Start Date2020-07-18

Study Completion Date2025-07-30

Terms related to this study

Additional Relevant MeSH Terms

Cardiomyopathy
Heart Failure
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm