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Status: CONCERT-HF is not recruiting new participants at this time.
Title: Combination Of meseNchymal and c-kit+ Cardiac stEm cells as Regenerative Therapy for Heart Failure (CONCERT-HF)
Purpose: Heart failure is a serious condition in which the heart muscle does not pump blood throughout the body as well as it should. Over a period of years, the heart’s pumping ability may continue to worsen and a heart transplant may become necessary. Alternative treatment options are limited. Also, because of the small number of donor organs, very few people receive heart transplants when they need one.
The purpose of this research study is to determine if c-kit+ cells produced from a sample of your heart muscle, mesenchymal stem cells (MSCs) produced from a sample of your bone marrow, either alone or in combination with each other, will safely help your heart to work better. Experiments performed in small and large animals suggest that giving either c-kit+ cells or MSCs alone, or the combination of c-kit+ cells and MSCs together, improves the ability of diseased hearts to pump blood throughout the body.
Enrollment: The target enrollment for the current trial is 144 participants across 7 clinical centers.
Title: Stem Cell Injection in Cancer Survivors (SENECA)
Purpose: Common use of a group of cancer medications called anthracyclines has dramatically improved cancer survival numbers over the past 50 years. Anthracycline-based cancer medications remain common and effective treatments for breast cancer, lymphomas, leukemias, and sarcomas. Unfortunately, the use of anthracyclines is limited due to their poisonous effects on the heart, including the development of a form of heart failure called anthracycline-induced cardiomyopathy (AIC). These effects can be seen as late as 20 years after the cancer treatment. Current treatments for AIC reduce the symptoms but there is no cure for this disease. While studies suggest that the usual medications used to treat heart failure (e.g. ACE inhibitors, angiotensin receptor blockers, beta-blockers, and statins) may help treat AIC, there continues to be a group of patients that will develop worsening symptoms and end-stage heart failure despite the best medical therapy, with many individuals worsening to the point of requiring a heart transplant.
Stem cells are cells that do not yet have a specific function in the body. Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown from bone marrow (the spongy tissue inside of bones). Stem cells can develop into other types of more mature (specific) cells, such as blood and muscle cells. It is hoped that by placing these cells into the heart, they will allow the heart to work better and reduce the scarred heart tissue associated with heart failure.
Rather than taking these cells from the patient’s own bone marrow (which has been exposed to the cancer medications in the past), MSCs can be taken from a healthy donor (who has never had chemotherapy). This type of stem cell is called allogeneic (or allo for short).
The purpose of this research study is to determine whether giving allo-MSCs to patients with AIC is safe and whether these treatments improve heart function.
Enrollment: 36 individuals were treated at 7 clinical centers and will be followed up for 24 months.