University of Iowa Hospitals and Clinics is one of the first medical centers in the country to participate in a clinical trial investigating if patients with a severe form of coronary artery disease can be treated using their own stem cells.
Mark Anderson, MD, PhD, director of the Division of Cardiology with UI Heart and Vascular Center located at University of Iowa Hospitals and Clinics, tells about the study:
Who is eligible to participate in the cardiac stem cell study?
These are patients who have intractable angina, a kind of pain that derives from heart muscle being inadequately supplied with blood. So these patients specifically have not had adequate relief from medications or from other treatments designed to improve blood flow to the heart muscle. Those are treatments such as bypass surgery or balloon or stent angioplasty therapies.
What is myocardial ischemia?
Ischemia is a condition where there is insufficient blood flow to provide the necessary nutrients and oxygen to a tissue. In the case of heart, ischemia is the cause of heart or chest pain.
How is it currently treated?
Ischemia is treated by a number approaches including:
Medical
- Reduce or prevent the clogging of arteries that bring blood to the heart
- Slow the heart and so reduce its demand for nutrients and oxygen
- Allow the blood vessels that bring blood to the heart to relax so that they're more efficient in carrying blood.
Non-medical treatments:
- Bypass surgery which is a way of taking an artery or a vein and having it bypass a narrowed area or a blockage in the artery
Interventional procedures:
- Using catheters to open up blockages in coronary arteries by balloons and stents
How many centers in the US are involved in the cardiac stem cell study?
I believe that there are now 14 centers working on this study. The University of Iowa was one of the very first. This study obviously brings up a new kind of therapy that's different from the previous studies and that's because the hope is that these cells will provide new blood vessels to bring blood into that ischemic tissue.
What will participants be asked to do as part of the study?
The patient will first be seen in our clinic or the clinic of their referring doctor to determine if they meet the initial eligibility requirements. Those requirements include things like very severe angina; the agreement between the cardiologist and a cardiac surgeon that there is not further room for revascularization, either surgical or with stents and balloons; and then they will undergo a series of non-invasive imaging tests, they keep a diary, they undergo a treadmill test to make sure that they are the people who are most likely to benefit from this type of therapy.
How long will the study last?
It could last several months and then after the treatment, they would be followed for more than a year to see if they benefit or not.
What do you and other researchers hope to learn from this study?
This is really a groundbreaking study so we hope to test the idea about whether injection of these cells could make people feel better. This is fundamentally a clinical endpoint; we want people to feel better. If that works, we'll be able to test other hypotheses about what is a mechanism for making them feel better. The leading hypothesis right now is that these cells have the capacity to grow a tiny network of new blood vessels to bring blood to this ischemic tissue.
If somebody is listening and they think that they could be a participant or they'd like to learn some more, is there a number that they can call to get some more information about this study ?
I'm glad you asked that, we have a very talented nurse organizer, Amy Ollinger, and she can be reached at 319-353-6675. It's important to state that this type of study really involves the cooperation of many talented doctors and nurses and technicians to provide the therapies, to screen the patients, to image the patients, and so it's really a tour de force. |
