Actively Recruiting

Phase 1
Age: 18Years - 80Years
All Genders
NCT02962661

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

Led by M.D. Anderson Cancer Center · Updated on 2026-01-07

72

Participants Needed

1

Research Sites

314 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with left ventricular ejection fraction (LVEF) of 40% or less caused by anthracycline treatment for any cancer.
  • Age between 18 and 90 years.
  • New York Heart Association (NYHA) class I, II, or III heart failure.
  • For patients previously treated with trastuzumab, persistent left ventricular dysfunction must be present 90 days after stopping trastuzumab.
  • Able to perform a 6-minute walk test.
  • Have received appropriate maximal medical therapy for heart failure.
  • Patient or legally authorized representative able to provide informed consent.
Not Eligible

You will not qualify if you...

  • Evidence of ischemic heart disease.
  • Significant valvular heart disease, including aortic stenosis with valve area less than 1.5 cm2, severe aortic or mitral regurgitation.
  • History of familial cardiomyopathy.
  • Recent myocarditis within 2 months before enrollment.
  • History of infiltrative or restrictive cardiomyopathy.
  • Presence of left ventricular thrombus.
  • Liver function tests greater than 3 times the upper limit of normal.
  • New York Heart Association class IV heart failure.
  • Dependence on inotropic medications.
  • Unstable or life-threatening arrhythmias.
  • For patients not on anticoagulants, INR greater than 1.5.
  • Presence of mechanical or bioprosthetic heart valves.
  • Cardiogenic shock.
  • Breastfeeding or pregnant women.
  • Autoimmune disorders currently treated with immunosuppressive therapy.
  • Active infection not responding to treatment.
  • Trastuzumab treatment within the last 3 months.
  • Automatic implantable cardioverter defibrillator (AICD) implanted within the last 30 days or fired within the last 30 days.

AI-Screening

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Amanda Olson, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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