Bone Marrow Derived Mesenchymal Stem Cells in Improving Heart Function in Patients With Heart Failure Caused by Anthracyclines

NCT02408432 | Completed Phase 1 FDA Drug

• 2 other identifiers: 2014-0519NCI-2015-00969
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot phase I trial studies the side effects and best method of delivery of bone marrow derived mesenchymal stem cells (MSCs) in improving heart function in patients with heart failure caused by anthracyclines (a type of chemotherapy drug used in cancer treatment). MSCs are a type of stem cell that can be removed from bone marrow and grown into many different cell types that can be used to treat cancer and other diseases, such as heart failure. Bone marrow derived MSCs may promote heart muscle cells repair and lead to reverse remodeling and ultimately improve heart function and decrease morbidity and mortality from progression to advanced heart failure.

Conditions

Cardiomyopathy; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events of intravenous injection of human mesenchymal stem cells (hMSCs) in patients with recent onset left ventricular systolic dysfunction from anthracyclines

  Statistical analyses of safety will be descriptive. In particular, will provide a table of adverse events.

  Up to 6 months

Secondary Outcomes (10)

• Change in improvement in left ventricular systolic function by 7 points

  Baseline up to 6 months

• Development of acute heart failure decompensation

  Up to 6 months

• Emergency center visits for heart failure

  Up to 6 months

• Need for new pacemaker/automatic implantable cardioverter defibrillator

  Up to 6 months

• New onset arrhythmias

  Up to 6 months

Study Arms (2)

Arm I (hMSCs)

EXPERIMENTAL

Patients receive allogeneic hMSCs IV over 10-20 minutes once weekly for 4 weeks and standard of care drugs for heart failure.

Other: Laboratory Biomarker Analysis; Other: Standard of Care; Drug: Mesenchymal Stem Cell Transplantation

Arm II (standard of care drugs)

ACTIVE COMPARATOR

Patients receive only standard of care drugs for heart failure.

Other: Laboratory Biomarker Analysis; Other: Standard of Care; Drug: Mesenchymal Stem Cell Transplantation

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (hMSCs); Arm II (standard of care drugs)

Standard of Care OTHER

Undergo mesenchymal stem cell infusion

Arm I (hMSCs); Arm II (standard of care drugs)

Mesenchymal Stem Cell Transplantation DRUG

Undergo mesenchymal stem cell infusion

Arm I (hMSCs); Arm II (standard of care drugs)

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% 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Cardiomyopathies; Heart Failure

Interventions

Standard of Care; Mesenchymal Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Amanda Olson

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

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: March 31, 2015
• First Posted: April 3, 2015
• Study Start: January 11, 2016
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

US (1)