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A Phase I First-in-Human Multicenter Randomized Double-Blinded Placebo- Controlled Study of the Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Cancer Survivors with Anthracycline-Induced Cardiomyopathy

Study of Investigational Treatment for Heart Dysfunction in Cancer Survivors

Recruiting
18-79 years
All
Phase N/A

This study investigates the safety and feasibility of using an investigational treatment involving allogeneic human mesenchymal stem cells (allo-MSCs) for cancer survivors who have heart problems. These heart problems are a result of a condition called anthracycline-induced cardiomyopathy (AIC), which happens when certain cancer treatments affect the heart's ability to pump blood. The goal is to see if the treatment can be safely given to these patients.

Participants in the study will receive the investigational treatment through a procedure called transendocardial injection. This means the treatment is delivered directly into the heart muscle. The study will monitor patients to ensure the procedure is safe and to observe any effects it may have on their heart condition.

  • Who can participate: Participants must be cancer survivors diagnosed with anthracycline-induced cardiomyopathy at least six months ago. They should have been cancer-free for at least two years with a low risk of recurrence. They must also be on stable heart medication and be suitable for cardiac catheterization.
  • Study details: Participants will receive an investigational treatment through a procedure that injects the treatment directly into the heart muscle. They will be monitored for safety and any effects on their heart condition. The study does not involve a placebo.
Study details
    cardiomyopathy

TX5993

19 February 2024

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