Stem Cell Therapy


Cardiovascular Cell Therapy Research Network (CCTRN):

CONCERT-HF

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.

For more information, visit:

CONCERT-HF on clinicaltrials.gov

Cardiovascular Cell Therapy Research Network

 

SENECA

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.

For more information, visit:

SENECA on clinicaltrials.gov

Cardiovascular Cell Therapy Research Network

 


Industry-Sponsored Trials:

MI-NSTEMI

Non-ST Elevation Myocardial Infarction

This is a trial for patients coming to the emergency room with a heart attack and who are enrolled at the time of going to the catheterization laboratory. The trial is evaluating the effect of donor stem cells to minimize the loss of heart function over time. Patients will be enrolled for one year into this trial.

MI-NSTEMI on clinicaltrials.gov

 

DREAM-HF

Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure (DREAM HF-1)

This is a trial for patients with heart failure (ejection fraction <40%) regardless of reason (with or without coronary artery disease). This trial will evaluate the effect of donor MSCs compared with placebo on heart function over time. Patients will be enrolled for one year.

DREAM-HF on clinicaltrials.gov

 

CardiAMP

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)

This is a trial for patients who have had a heart attack in the past and have heart failure as a result. This trial will evaluate the effect of administering the patient’s own bone marrow stem cells directly into the most affected parts of the heart, compared with placebo, on heart function over time. Patients will be enrolled for one year.

For more information visit:

CardiAMP Trial site

CardiAMP on clinicaltrials.gov


Please contact our Clinical Trials Office for information: (352) 273-8933  ufcardiovascularct@medicine.ufl.edu