About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Best Practice
  • Laboratory Biomarker Analysis
  • Mesenchymal Stem Cell Transplantation
  • Mesenchymal Stem Cell Transplantation

Treatment groups

72 Participants
are divided into 3 treatment groups

Locations

1
M D Anderson Cancer Center77030, HoustonTexas, United States

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator