Cell Therapy

Cardiovascular Cell Therapy Research Network (CCTRN)

CONCERT–Enrolling

Combination Of meseNchymal and c-kit+ Cardiac stEm cells as Regenerative Therapy for Heart Failure (CONCERT-HF)

Heart failure is a serious and common 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 continues to get worse and a heart transplant may become necessary. Treatment options are extremely limited.

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). C-kit+ Cardiac Stem Cells (CSCs) are stem cells that can be grown from a sample of tissue collected from the heart. Stem cells can develop into other types of more mature cells, such as blood and muscle cells. It is hoped that by placing these cells in the heart, they can give rise to new muscle that will allow the heart to work better.

The purpose of this research study is to determine whether giving MSCs and/or CSCs to patients with heart muscle damage is safe. It will also help us learn whether these treatments improve heart function for people who are not ideal candidates for other forms of standard therapy such as surgery or techniques used to widen or unclog an artery.

SENECA–Enrolling

Stem Cell Injection in Cancer Survivors (SENECA)

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.

CCTRN Studies in Followup–Enrollment Complete:

  • PACE–Patients with Intermittent Claudication Injected with ALDH Bright Cells
  • CTSN/CCTRN LVAD–The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation
  • TIME–Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack
  • LateTIME–Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack
  • FOCUS–Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy

Industry Sponsored Trials

Heart Failure

ALLSTAR

ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration

This Study involves research about a product called “CAP-1002 Allogeneic Cardiosphere-Derived Cells” (“CAP-1002”). CAP-1002 is a biologic product consisting largely of cells grown from donated human heart muscle tissue. The purpose of this Study is to evaluate the safety and effectiveness of CAP-1002 in the treatment and/or prevention of left ventricular (LV) dysfunction following myocardial infarction (MI), also known as a “heart attack”. The Study will also examine whether the use of CAP-1002 can decrease the amount of heart muscle damage and/or improve heart function after a heart attack. The amount of heart muscle damage and the function of the heart directly affect health over time and the development of heart failure and other complications some people experience after a heart attack. In this Study, CAP 1002 is considered to be investigational (not approved by the FDA) for treatment and/or prevention of LV dysfunction following MI.


Please contact our Clinical Trials Office for information:  (352) 273-8933