MINNEAPOLIS, Minn. (Ivanhoe Newswire) - About 5.8 million Americans have heart failure, a condition that occurs when the heart can no longer pump enough blood to meet the body's needs. Now, researchers said a special type of stem cell may be the key to repairing these hearts.
Golf has always been a big part of Ron Signorelli's life.
"I started when I was ten," Ron told Ivanhoe.
However, Ron's congestive heart failure was keeping him away from his favorite pastime.
"I was in the hospital over 20 times," Ron said.
Ron's heart pumped only 15 percent of blood. He needed help fast.
"There's a large number of patients out there that are really in this situation where they're gone past what normal medical therapy can do, but yet they're not sick enough or don't qualify for a heart transplant," Timothy D. Henry, MD, Director of Research Minneapolis Heart Institute Foundation, told Ivanhoe.
Now, a new approach can help patients like Ron. First, doctors extract bone marrow stem cells from the patient. Then, they grow the cells to enhance their healing ability. Those cells are then injected directly into the patient's heart.
"Our hopes are we improve the quality of their life, as well as the length of their life," Dr. Henry said.
In the first clinical trial, the treatment was safe, repaired damaged heart muscles, and even appeared to reverse some heart failure symptoms. Ron had 12 injections and hasn't been to the hospital since.
"I certainly feel good. I'm a very active person," Ron said.
Now, nothing stops his stride.
"When the weather is nice, I'll play three, four times a week," Ron explained.
Researchers are planning enrollment for the second phase of this trial at about 30-sites across the U.S. Once the results are assessed, the treatment will likely be more widely available. This therapy would not replace a heart transplant, but may delay or prevent the need for transplantation in the future.
BACKGROUND: Heart failure is a very common condition, affecting 5.8 million people in the U.S. It is a condition where the heart can't pump enough blood to meet the body's needs. In some cases, the heart can't pump blood to the rest of the body with enough force. In others, the heart can't fill with enough blood; some people have both problems. "Heart failure" doesn't mean that the heart has stopped working, but it is still a serious medical condition that needs immediate care. The condition can develop over time as the heart's ability to pump gets weaker. In many incidences, it involves both sides of the heart. Right-side heart failure occurs when the heart can't pump enough blood to the lungs to pick up oxygen. Left-side heart failure happens if the heart can't pump enough oxygen-rich blood to the rest of the body. Other names for heart failure are called congestive heart failure and cor pulmonale (this refers to right-side heart failure caused by high blood pressure in the pulmonary arteries and right ventricle). (Source: http://www.nhlbi.nih.gov/health/health-topics/topics/hf/names.html)
CAUSES: Conditions that overwork or damage the heart muscle can cause heart failure. The heart weakens over time and is not able to fill with or pump blood as well as it used to. As it weakens, certain proteins and substances might be released into the blood. The substances are toxic on the heart and blood flow, causing heart failure to worsen. Common conditions that cause heart failure include:
Coronary Heart Disease—A waxy substance (called plaque) builds up inside the coronary arteries. Plaque narrows the arteries and reduces blood flow to your heart muscle.
High Blood Pressure—If blood pressure rises and stays high, it can weaken the heart and cause plaque buildup. Blood pressure is high if it is at or above 140/90 mmHG over time.
NEW TECHNOLOGY: Treatment for heart failure depends on the type and stage. Treatments usually include lifestyle changes, medicines, and ongoing care. However, a phase 2 clinical trial offers another possible treatment option. So far, the study has shown that a patient's own bone marrow stem cells improved heart function in some patients with progressive heart failure due to dilated cardiomyopathy (DCM). "An increasing number of patients have progressive heart failure due to DCM, even after treatment with drug therapy and surgical intervention," Dr. Timothy Henry, principal investigator, director of research, and an interventional cardiologist at the Minneapolis Heart Institute, was quoted as saying. "In this study, patients treated with ixmyelocel-T showed repair in damaged heart muscle and some reversal in heart failure symptoms." The treatment involves both stem cells and immune cells that are primed to do the job, instead of focusing only on one gene or cell type. Ixmyelocel-T was developed by culturing a patient's bone marrow for 12 days in order to increase the numbers of immune cells, including monocytes and macrophages, along with mesenchymal cells (stem cells that can differentiate into several different cell types). The treatment was then injected into the patient's heart muscles to encourage new tissue growth and improve inflammation. The study involved 22 ischemic (IDCM) and non-ischemic (NIDCM) patients with moderate to severe heart failure. Patients were randomly chosen to receive the treatment or a placebo. They were followed at three, six, and twelve month intervals. "Treatment with ixmyelocel-T was well-tolerated, and patients who received the cell therapy showed improved symptoms after one year. Although the study is preliminary and involved only a small group of patients, its results suggest the treatment is safe and provides a strong basis for a larger clinical trial," Dr. Henry was quoted as saying. (Source: http://www.prnewswire.com/news-releases/treatment-with-ixmyelocel-t-shown-to-improve-outcomes-in-heart-failure-patients-150992345.html)
Timothy Henry, MD, FACC, Director of Research at the Minneapolis Heart Institute Foundation, talks about a new stem cell treatment is saving patients who have heart failure.
What is the name of this treatment?
Dr. Henry: The trial is called Ix-CELL-DCM and the cell therapy product is called Ixmyelocel-T. In regards to cell therapy, we are now past the first generation. The first generation takes stem cells from bone marrow, which we gave to the patient for a variety of different cardiovascular conditions. What we learned from the first generation was that there is modest improvement and it is very safe. However, one of the major issues is as the patient gets older, the number of stem cells and the potency of the stem cells declines, which is a major limitation overall. Aging is a process of losing our regenerative capacity. We are looking at ways to enhance the first generation of bone marrow stem cells. What we do in this situation is we take the bone marrow stem cells and then over a course of a 3-week process, we expand and enhance the cells. Basically, we increase the number of good cells and decrease the number of bad cells. So, theoretically we have a product that is better at improving heart function.
Once that process is done, what happens next?
Dr. Henry: After we have expanded, or enhanced the bone marrow cells, we inject the cells directly into the heart muscle of the patient. These are patients who have severe heart dysfunction, or ischemic dilated cardiomyopathy, patients with bad blockages in their heart, which led to heart attacks. Most patients have areas where they are not getting enough blood supply and areas where the heart muscles is damaged and our goal is to improve that heart function.
What will the stem cells do when they get into the heart?
Dr. Henry: The stem cells are injected directly throughout multiple areas of the heart muscle. In many patients, we need to grow new blood vessels or improve the blood supply and other patients need to improve the heart muscle cells. Hopefully with Ixmyeloce I-T, we are working on both of those processes.
What have you seen in the trial so far with patients?
Dr. Henry: We have improved our therapies with in cardiology that an increasing number of people have complex heart disease, but are still alive. The options for these people are limited. After you have had a heart attack, over the next 5 to 10 years, your heart frequently gets larger and the function decreases, which results in a slow, steady decline. When they get to a certain point, we call that class 3 or class 4 heart failure. Patients are very limited in their activities. Despite our best medications and despite our best device therapy, the patient may be able to only walk 2 or 3 blocks. At that point, the options are really limited. Heart transplantation and there is a limited number of hearts. Also, as you get older, you may or may not be a candidate. The second often is left ventricular assist devices, or a special heart pump. We are making progress in that area, but not available for many patients. A frequent problem in cardiology is patients with heart failure who are past the best medical therapy, but yet are not sick enough or not eligible enough for heart transplant. So, this is a patients with a significant decrease in their quality of life and at risk for dying. This is a large unmet need; cardiovascular cell therapy is really a great opportunity in this patient population. Our hopes are that we can improve both the quality of their life as well as the length of their life.
Is that what you were seeing in the trial?
Dr. Henry: In the first phase of the trial, we treated in both people with ischemic heart failure or cardiomyopathy, which are patients who have inadequate blood supply. And patients who have decreased heart function just for many other reasons. In the first phase of the trial, we saw that it worked better for the patients who have the ischemic cardiomyopathy. So, in the second phase of the study we are focusing specifically on these patients, patients who have a significant decrease in their heart function, whose activity is extremely limited and difficulty with heart failure over the last 6 to 12 months. This is a high risk patient population with limited treatment options.
Are their hearts getting stronger? Are they having fewer problems and feeling better?
Dr. Henry: Yes. In phase 1, patients tolerated the procedure well. With no complications related to the cell therapy or the cell injection into the heart muscle. Patients with ischemic cardiomyopathy had an improvement in their heart function as well as an improvement in their quality of life. It was very promising and led to the next phase 2 trial.
Is phase 2 still going on or is that completed now?
Dr. Henry: Phase 2 is actively recruiting right now.
Is it recruiting?
Dr. Henry: Yes, we are recruiting. We are excited because there are a large number of patients in this situation past normal medical therapy, but yet not sick enough to qualify for a heart transplant or a left ventricular assist device.
What kind of condition was Ron's heart in?
Dr. Henry: Ron was in phase 1 of the trial and he had a severe decrease in his heart function. When the heart muscle pumps, about 65% of the blood is ejected. We call that the ejection fraction. His ejection fraction was about 15%, which is a very severe decrease in his heart function. He was very limited, with class 4 heart failure. So it was difficult for him to even go a few blocks and certainly he could not do his normal daily activities. He had been dealing with it for 20 or 30 years. He had several heart attacks with a slow progressive downhill course. When he came to us, 3 years ago now, he was enrolled in the trial. He had a remarkable response with significant improvement in his activity. His function improved a little. This is not going to be a therapy that magically makes your heart muscle normal. Hopefully can repair the quality of life, but I think the improvement in the heart function is modest. Our hope is to stabilize it. Ron is much better now and he is playing golfing.
So, can you discuss further how it is not a "magic cure?"
Dr. Henry: This is a really important issue because people hear about cell therapy and they think it is a magic cure is really not realistic. We are excited about cell therapy because it has potential, which to enhance the way the body naturally heals itself. So, this is the natural process of regeneration; really in all areas of your heart. It is a normal process. Our goal is to enhance that normal process, which in many cases is inadequate and as we get older our ability to regenerate declines. We are excited about the concept of cell therapy for that reason. However, we should not have unrealistic expectations. It is really like any other therapy. You need to do it stepwise. The first step find out what works, what does not work, if it is safe, and then go to the next phase. It needs to be a well thought out process so that we really can find ourselves with the best therapies. Another thing I think is really important is that first generation of cells (plain bone marrow) was very safe. This is encouraging, but I think we believe we can do better. There is a number of ways to make cell therapy better. One is to take regular bone marrow cells and enhancing the cells by increasing the number of good cells, and decreasing the number of bad cells.
In the first generation, would you just take them right out and put them right in the heart immediately?
Dr. Henry: Exactly.
FOR MORE INFORMATION, PLEASE CONTACT:
Timothy D. Henry, MD Director of Research Minneapolis Heart Institute Foundation (612) 863-3833
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