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

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Best Practice — OTHER
  Given standard of care
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Mesenchymal Stem Cell Transplantation — DRUG
  Given IV
• Mesenchymal Stem Cell Transplantation — DRUG
  Given transendocardially

Study Details

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.

Key Dates

Start date

Jul 18, 2020

Status verified

Jan 2026

Primary completion

Jul 30, 2026

Completion

Jul 30, 2026

Study Design

Enrollment

72 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (hMSCs IV)
  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.
• Experimental: Arm II (hMSCs transendocardially)
  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.
• Active Comparator: Arm III (standard of care)
  Patients receive standard of care treatment for heart failure.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 6 months ]

Central Contacts

• Amanda Olson, MD
  713-745-3055
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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