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

NCT02962661 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2015-0835NCI-2016-01921
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiomyopathy; Heart Failure; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Statistical analyses of safety will be descriptive.

  Up to 6 months

• Change in left ventricular ejection fraction (LVEF)

  The comparison will be between the two groups of patients.

  Baseline to 6 months

Secondary Outcomes (7)

• Change in improvement of left ventricular (LV) systolic function as assessed by LVEF

  Baseline up to 6 months

• LV end-systolic and end-diastolic volumes as determined by contrast-enhanced 2-dimensional(D)/3D echography

  Up to 6 months

• Cardiac death

  Up to 6 months

• Re-hospitalization after heart failure

  Up to 6 months

• Aborted death from an automatic implantable cardioverter defibrillator (AICD) firing

  Up to 6 months

Study Arms (3)

Arm I (hMSCs IV)

EXPERIMENTAL

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.

Other: Best Practice; Other: Laboratory Biomarker Analysis; Drug: Mesenchymal Stem Cell Transplantation

Arm II (hMSCs transendocardially)

EXPERIMENTAL

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.

Other: Best Practice; Other: Laboratory Biomarker Analysis; Drug: Mesenchymal Stem Cell Transplantation

Arm III (standard of care)

ACTIVE COMPARATOR

Patients receive standard of care treatment for heart failure.

Other: Best Practice; Other: Laboratory Biomarker Analysis

Interventions

Best Practice OTHER

Given standard of care

Also known as: standard of care, standard therapy

Arm I (hMSCs IV); Arm II (hMSCs transendocardially); Arm III (standard of care)

Mesenchymal Stem Cell Transplantation DRUG

Given IV

Arm I (hMSCs IV)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (hMSCs IV); Arm II (hMSCs transendocardially); Arm III (standard of care)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age \>/= 18 and \</= 90 years of age. English and non-English speaking patients are eligible.
• Documented NYHA class I, II and III.
• For patients who have received trastuzumab: Persistent LV dysfunction must be present 90 days after discontinuation of trastuzumab.
• Able to perform 6 minute walk test.
• Been treated with appropriate maximal medical therapy for heart failure.
• Patient or legally authorized representative able to sign informed consent.

You may not qualify if:

• Evidence of Ischemic Heart Disease as determined by study cardiologist.
• Significant Valvular Disease. (AS with AVA \<1.5 and severe AR and MR)
• History of Familial Cardiomyopathy.
• Recent documented myocarditis within 2 months of enrollment.
• History of Infiltrative cardiomyopathy or restrictive cardiomyopathy.
• Presence of left ventricular thrombus as documented by echocardiography or left ventriculogram.
• Liver function tests \> 3 x upper limit of normal.
• NYHA class IV heart failure.
• Inotropic dependence.
• Unstable or life-threatening arrhythmia.
• For patients not on anticoagulants, INR\>1.5
• Mechanical or Bioprosthetic heart valve.
• Cardiogenic shock.
• Breastfeeding and/or pregnant women.
• Autoimmune disorders on current immunosuppressive therapy.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Cardiomyopathies; Heart Failure; Hematologic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Mesenchymal Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Amanda Olson, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Olson, MD

CONTACT

713-745-3055; alolson@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 11, 2016
• Study Start: July 18, 2020
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)