Debbie Minch is thankful for each day.
"Grace is what's carried me through this," Minch told Ivanhoe.
Ten years ago, at just 49, the choir singer and her husband were told she would need a quadruple bypass.
"Now we are at the point where my heart is severely damaged and nothing is really helping," Minch said.
Doctors said a heart transplant was her only option, but she'll soon find out if she'll be accepted into a new trial that could use her own stem cells to help repair the once thought irreversible damage, "or even create new blood vessels within areas of the heart that have been damaged," Jon George, MD, Interventional Cardiologist, Temple University School of Medicine, told Ivanhoe.
First, stem cells are taken from a patient's bone marrow. Then using a special catheter and 3D mapping tool, the cells are injected directly into the damaged tissue.
"We have results from animal data that show blood vessels regrow in the patients that actually get stem cell therapy," Dr. George said.
It's a possible answer to Debbie's prayers.
Temple University Hospital is currently pre-screening patients for the trial. For more information, call 215-707-5340.
BACKGROUND: Coronary heart disease, or CHD, is when a waxy substance called plaque builds up inside the coronary arteries. These are the arteries that supply oxygen-rich blood to the heart muscle. The plaque buildup occurs over many years. The hardened plaque narrows the coronary arteries and then reduces the flow of oxygen-rich blood to the heart. CHD is the most common type of heart disease. CHD is the number one cause of death for both men and women in the United States. (Source: www.cdc.gov)
CAUSES: CHD can be caused by smoking, high levels of certain fats and cholesterol, high blood pressure, high levels of sugar in the blood and blood vessel inflammation, all of these things can damage the inner layers of the coronary arteries. The buildup of plaque in the coronary arteries can start during childhood. Blocked coronary arteries can cause a heart attack down the road, or could lead to heart failure or stroke. (Source: National Institute of Health)
NEW TREATMENTS: A new treatment is being tested that uses the patient's stem cells. The stem cells are taken from the patient's bone marrow. Doctors use a special mapping tool to see the exact areas of the heart that are damaged. Then they will inject the cells directly into the borders surrounding those areas. The stem cells, because of their nature, can turn into any cell in the body. So far, results from animal data show regrown blood vessels in the patients who have gotten the stem cell therapy. The hope is that the cells can stimulate a normal blood flow by correcting the disease in the existing vessels. (Source: Temple University School of Medicine).
How big of a problem is coronary artery disease is in the United States?
Dr. George: It's a major problem. We have millions of patients in the United States that have an established diagnosis of coronary artery disease, which just means that you have blockages in the arteries feeding the heart. Typically when that blockage becomes severe enough that it prevents blood flow into a certain territory of the heart, then you have a heart attack. A number of patients have heart attacks and cause irreversible damage to the heart muscle. And the question is what can we do to prevent that? A variety of things can prevent it; with diet, medications, lifestyle changes. But in the setting that you do have a heart attack, the standard therapy is to go in with a catheter and open up the blockage inside the artery and put a stent in to keep it open.
So what's the problem with that then?
Dr. George: Well the problem is that a lot of patients show up after a prolonged period of low blood flow to the heart. So once the damage is irreversibly done, then opening up that artery doesn't necessarily improve the heart muscle that's been damaged. Once the damage is done, it's permanent.
But now we have something that could possibly fix the damaged heart muscle?
Dr. George: That's right. For several decades, we thought that once the heart muscle damage had occurred it was permanent and there was no way to fix it. If the damage is not complete you can fix it by opening up the blockage. We found over time that our body produces these cells called stem cells within the bone marrow that are able to regenerate part of the heart muscle that has perhaps been damaged, or could even create new blood vessels within areas of the heart that have been damaged. And so now there's a lot of research being done to try to harness those cells that your body already produces to use them to regenerate heart muscle that's been damaged or to re-create blood flow into those areas that have been affected.
So the cells are actually being taken from your own body?
Dr. George: That's correct for most current treatment options. There is also some research being done on using cells from other healthy donors.
What does the process look like?
Dr. George: So if the patient meets the criteria for the study: which would be ongoing chest pain despite maximal therapy with medication, stents, and surgery. If they are eligible for the study and they go through the screening process, then the next step would be to mobilize the stem cells from their body. And so they get this medication called GCSF, which is an injection in the arm or in the muscle that helps mobilize all of these cells from the bone marrow into the bloodstream. They get that for five days in a row and on that fifth day, those cells are actually isolated from the bloodstream then injected back into the heart muscle. So you target it for areas of the heart that have been damaged. We have these catheters that are able to map the inside of the heart and actually show us the territories of the heart that are damaged by a prior heart attack for example, and we're able to deliver these cells through a specific injection catheter right to the area that needs the cells.
Do you use a dye to see the different damaged areas?
Dr. George: No, it's an actual catheter. It's connected to a big machine, a console that actually allows you to look at the conduction system of the heart and maps out whether each particular point this catheter touches is functionally active or not. And by touching multiple points inside the heart you're able to map out the area that's been damaged by showing the points that are not active. Once you create that three dimensional map of the inside of the heart you are then able to go in and use a little needle at the tip of the catheter to inject the cells that are necessary to try to regenerate the heart muscle right in the area that needs them.
Are there any specific stats that have come back yet?
Dr. George: So we have results from animal data that show blood vessels regrow in the patients that actually get stem cell therapy. In humans it's harder to demonstrate that new blood vessels actually regrow. All we know is that their symptoms improve. So the symptoms that they are associated with, such as ongoing chest pain that was not being treated with maximal medical therapy and all the treatments that we have available, improved. So their quality of life improves and also their functional capacity, that is, how much exercise they can do, actually improves after they get this therapy.
How big of a breakthrough would you say this is?
Dr. George: Well I mean we've been working for alternative therapies for this big problem that we have. This is a huge opportunity for patients to have an option for therapy if it truly works. And again this is still a little premature in the sense that the Phase III clinical trial is not done yet but if the results look as promising as they have in Phase I and Phase II then I think this is going to be a huge opportunity for treating patients that have this problem.