For more information about NIH Clinical Trials and the importance of participating,
please click on the following link:
PACE – Enrolling
Title: Clinical and MR Imaging Assessments in Patients with Intermittent
Claudication Following Injection of Bone Marrow Derived ALDH Bright Cells (PACE)
Purpose: Peripheral Artery Disease (PAD) occurs when arteries
in the arms and legs (most often the legs) become narrowed by plaque. Because of
this plaque, patients with PAD are also at increased risk for heart attacks and
strokes. Those with PAD often have intermittent claudication (blockage of blood
vessels in the leg). This blockage decreases blood flow to the leg muscles, which
can cause pain in one or both of your legs when you exercise (such as during walking).
Bone marrow contains special stem cells that may promote blood vessel growth, prevent
cell death, and transform themselves into a number of tissues including new muscle.
There is a small subpopulation of bone marrow mononuclear cells, called aldehyde
dehydrogenase-bright (ALDHbr) cells, that is highly enriched in these types of stem
cells. The enzyme in ALDHbr cells responds to damage signals and may play an important
role in tissue repair.
The purpose of this study is to find out if these cells taken from your bone marrow
can be placed safely, via intramuscular injections, into your affected calf and
lower thigh muscles and improve the blood flow; thereby decreasing the pain associated
with blocked blood vessels in your leg.
Enrollment: 80 individuals will be enrolled at 8 clinical centers
and will be followed up for 12 months.
CONCERT – Enrolling in Fall 2015
Title: Combination Of meseNchymal and c-kit+ Cardiac stEm cells as Regenerative Therapy for Heart Failure (CONCERT-HF)
Purpose: Heart failure is a serious and common condition. It is a 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
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.
Enrollment: 160 individuals will be enrolled at 7 clinical centers and will be followed for 24 months.
SENECA – Enrolling in Spring 2016
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 will be enrolled at 7 clinical centers and will be followed up for 24 months.
CTSN/CCTRN LVAD – Enrollment Complete
TIME - Enrollment Complete
LateTIME - Enrollment Complete
FOCUS - Enrollment Complete
If you are interested in getting more
information about participating in the above studies, please click here to find
the CCTRN clinic closest to you.