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Stem Cell Therapy for Heart Disease (Dr. Ellis 10/11/10)

Monday, October 11, 2010 - Noon

Stephen Ellis, MD
Section Head of Invasive/Interventional Cardiology, Robert and Suzanne Tomsich Department of Cardiovascular Medicine

Description

Stem cells are nature’s own transformers. When the body is injured, stem cells travel to the scene of the accident and help heal damaged tissue. The cells do this by transforming into whatever type of cell has been injured- bone, skin and even heart tissue. Researchers at Cleveland Clinic believe that the efficiency of stem cells for treating heart tissue can be boosted and help the body recover faster and better from heart attacks. Join us in a free online chat with cardiologist Stephen Ellis, MD. Dr. Ellis is leading one of the clinical trials and will be answering your questions about stem cell therapy for heart disease.

More Information

Cleveland_Clinic_Host: Welcome to our "Stem Cell Therapy for Heart Disease" online health chat with Stephen Ellis, MD. Dr. Ellis is leading one of the research studies for stem cell therapy and heart disease so he will be answering a variety of questions on the topic. We are very excited to have him here today!

Thank for joining us Dr. Ellis, let's begin with the questions.

Dr__Ellis: Thank you for having me today.


Stem Cell Research Trials

Robert_B: I have a question on Stem Cell and stabilizing a two chamber heart condition.. Could donor adult stem cells help stabilize the heart and repair some of the damage? Patient also suffers from cardiac sclerosis of the liver.

Dr__Ellis: Stem cells are currently being evaluated to see if they may or may not strengthen hearts previously damaged by heart attacks or other conditions. They are considered experimental for this purpose. There are several ongoing clinical trials available in the U.S.

cabbagepatch: I have been going through other tests for heart transplant consideration, & with everything I have been going through would I be a candidate for heart stem cell repair? How would I find out? My cardiologist is Dr. Hsich in Cleveland.

Dr__Ellis: You may be a candidate for the NIH FOCUS trial at the Cleveland Clinic. Please ask Dr. Hsich - she would be able to help you.

SUZ666: how ? and where are there trials? at which hospitals

Dr__Ellis: If you have heart muscle damage from heart attacks and an ejection fraction less than 45% you may be able to be in a trial here at Cleveland Clinic - otherwise you may want to do a search at www.clinicaltrials.gov to see what studies you may be eligible for.

dastaz59: What's the focus of the research?

Dr__Ellis: The vast majority of clinical trials of stem cells for heart disease patients have focused on angina or ischemic cardiomyopathy and limited treatment options. We hope to improve blood flow and hence, diminish angina and also improve heart muscle function.

AMilton: Are there any limitations to doing stem cell treatment if you have an ICD?

Dr__Ellis: No - patients with ICDs are still eligible.

george: how do you know if you are a candidate for this research?

Dr__Ellis: If you have rather severe angina or short windedness due to heart artery blockages you may be a candidate for stem cell research. This is currently research. A good list of clinical trials is at www.clinicaltrials.gov - search on stem cell therapy heart.

kel1: Can you describe stem cell therapy - what is involved in it - is it frequent treatments? and how do they know if you are helped or not?

Dr__Ellis: Most stem cells used in clinical trials today come from bone marrow or fat tissue. To obtain bone marrow cells one undergoes an aspiration procedure under moderate sedation - it is a little uncomfortable but seems to carry very little risk. Obtaining stem cells from fat tissue requires a procedure very similar to liposuction.

All or almost all clinical trials involve one injection but there is good reason to believe that multiple injections may be beneficial and they will be tested in the future. While sophisticated imaging techniques such as echo are usually used as markers for benefit you can tell if you benefited by improvement in symptoms.

flowers3: Do you think this is something where someone can donate stem cells to another person?

Dr__Ellis: It turns out that some forms of stem cells are not rejected when administered to another person. We still have a lot to learn about this however and I am not aware of an active study where a person can donate stem cells to another.

my_joy: Where does the research stand at this point as far as human application?

Dr__Ellis: There is a large number of clinical trials, particularly in patients with recent heart attacks or heart damage after a heart attack in the US and elsewhere ongoing. Available studies suggest heart muscle function can be improved after heart attack. Stem cells are still considered experimental.

AMilton: are patients with LVADs eligible to stem cell trials?

Dr__Ellis: There are LVAD clinical trials - check www.clinicaltrials.gov

AMilton: are there any trials that use stem cells from the patience blood? or just bone marrow and fatty tissue?

Dr__Ellis: There are a few trials going on with the patient's own blood - check clinicaltrials.gov

AMilton: if there are other exclusion criteria keep a patient from qualifying from a trial - do you have any data to support then stem cell treatment will be an approved option for patience in the US?

Dr__Ellis: For a full list of exclusion and inclusion criteria, please contact our study coordinator Carrie Geither at GEITHEC@ccf.org or look at www.clinicaltrials.gov.

vikram: SO IF ALL THE DAMAGED HEART MUSCLES ARE CREATED AFRESH AFTER STEM CELL INJECTION- THEN CAN YOU SAY THERE WILL BE NO NEED FOR ANY MEDICINES OR OTHER THERAPIES?

Dr__Ellis: Unfortunately stem cell therapies are nearly well enough advanced to replace all damaged heart muscle so I think you will not be able to get rid of all your medicines.


Types of Stem Cells and Therapy

Karen_T: I read in the NYT that there are law suits attempting to stop embryonic stem cell research. Will this impact the stem cell research going on for heart disease?

Dr__Ellis: The term stem cells actually encompass a wide variety of cells. Embryonic stem cells perhaps have the most promise but their acquisition comes with considerable controversy, restrictions on their use would adversely affect ongoing research.

Edward: Can you explain to me what exactly stem cells are, where they come from and what they do to help your heart?

Dr__Ellis: Stem cells are primitive cells that when they divide can lead to one cell that is self perpetuating and another cell that can turn into a more mature cell (e.g. like a heart muscle cell). They can come from the bone marrow (from the inside of the bone), fat tissue; and other places such as the placenta or umbilical cord. Each of these places provides a slightly different type of stem cell in terms of their capacity to change into different types of cells.

buddy: Is there a big difference in embryonic and other types of adult stem cell research?

Dr__Ellis: Embryonic stem cells seem to be more readily coaxed to form certain types of other cells (e.g. heart cells) than adult stem cells.


Stem Cell Therapy and Coronary Artery Disease

Suzanne: DOES STEM CELL THERAPY APPLY TO THE BLOCKAGE OF THE CORONARY ARTERIES? I.E. I HAVE 15 STENTS AND 18 ANGIOPLASTIES ALONG WITH GAMMA RADIATION.....CAN STEM THE STEM CELL APPLICATION HELP THIS CONDITION? AT THIS TIME I HAVE NO ACTUAL HEART DAMAGE OTHER THAN THE ARTERIES.

Dr__Ellis: Stem cell therapy remains experimental but there are strong suggestions that it can increase blood flow to the heart by the formation of small blood vessels in patients that have blockages to their own arteries. At present you would have to enter into a clinical trial to receive stem cells for this reason in the U.S.

vikram: MY QUERRIES ARE--WHY DID THIS CARDIAC/ V.F- ARREST HAPPEN AFTER FIVE YEARS OF THE FIRST HEART ATTACK,DESPITE MY TAKING MEDICINES REGULARLY.-HOW DID THE LVEF GO DOWN FROM 32% TO 21% OVER FIVE YEARS DESPITE TAKING REGULAR MEDICATION.HAS SOME MORE DAMAGE OCCURRED TO THE HEART MUSCLES THE SECOND TIME ?-IS ICD ENOUGH SAFE GUARD FOR THE FUTURE-WHAT DOES LIFE HOLD FOR ME REGARDING THE PROGRESS OF MY HEART CONDITION. WHAT NEW PROBLEMS WILL/CAN COME, ARE THESE AVOIDABLE.ARE THERE SOME MORE TREATMENTS--LVAD -CRT -EECP -CATHEDER ABLATION-TRANSPLANT ETC. CAN THESE BE GOOD FOR ME-IS STEM CELL TREATMENT RIGHT FOR ME.IF YES HOW / WHERE TO GO ABOUT IT AND AT WHAT COST.

Dr__Ellis: Cardiac arrest after large heart attack can occur many years after the event so in that regard you are not unusual. Often times the stress on the remaining live tissue in the heart after a big heart attack takes its toll after time, so the LV ejection can diminish. If you have symptoms at rest or with very little activity you should be evaluated at a heart failure center to adjust your medications and to be evaluated for LVAD and/or heart transplant.

If you have symptoms but they are not that bad, then you may be a candidate for stem cell therapy (e.g. FOCUS study at Cleveland Clinic).

srbrsn11: Are you using stem cell technology to address coronary artery disease? My right coronary artery is blocked and cannot be bypassed or stented.

Dr__Ellis: Stem cell therapy is currently being evaluated here for persons such as yourself provided your LVEF is less than 45%. It is hard to keep track of all the studies in this field so if your EF is greater than 45 you may want to check www.clinicaltrials.gov.

hafidb11: I have been stented three times and had restenosis every time. I am now waiting to have by-pass. will stem-cell help restenosis?

Dr__Ellis: The process of restenosis is usually due to an exaggerated scarring response - there are no ongoing stem cell trials that I know of to address this issue.

SUZ666: what specific name is the trial for coronary artery disease?

Dr__Ellis: FOCUS is the name of the NIH trial here at Cleveland Clinic for patients with ischemic cardiomyopathy. Check www.clinicaltrials.gov for other trials.

cherylt: I read this article online where this guy was injured with a nail gun into his heart. Because of this he had a heart attack and used stem cell therapy to repair his heart. It is amazing? Can you see this happening for other people who have had heart attacks?

Dr__Ellis: Patients with bad heart attacks are at the top of the list of those most likely to benefit and those for entry into clinical trials. If stem cell therapy is really going to work, these are the patients whom these will most likely be first approved.

my_joy: I have seen that most of the research is with patients with recent MIs but what of old scaring?

Dr__Ellis: There are clinical trials available for patients with older scars. If you have adjacent live muscle that is starved for blood, you may be eligible for entry into the NIH focus trial. Please contact GEITHEC@ccf.org and/or check www.clinicaltrials.gov.

Geritol: I am six years post MI with EF of 35% but stable over that time and not yet moving into heart failure. When can I expect stem cell therapy to apply to my condition?

Dr__Ellis: As noted in other comments, most of the emphasis in clinical trials of stem cell therapy thus far has been in patients apparently sicker than you are. If they benefit than you can expect clinical trials to move to patients with less advanced disease. Realistically we are looking at least a decade for persons like yourself.


Dilated Cardiomyopathy

Pam: I have dilated cardiomyopathy with congestive heart failure - ejection fraction at 20 %. I want to know if there is any stem cell therapy for my condition?

Dr__Ellis: Most stem cells studies to date have focused on heart muscle damage due to heart attacks not dilated cardiomyopathy. Although, animal research suggest that some forms of dilated cardiomyopathy may benefit from this as well. See www.clinicaltrials.gov

cab40: I have asymptomatic (dx'd on family history (two direct relatives) and echo EF~50% - also have moderate mitral valve disease). Are there ANY research trials for idiopathic/familial dilated cardiomyopathy? All of the research/clinical trials I have seen are for CAD type heart disease only. I cannot tolerate beta blockers - this may be my only hope. I am only 41 yrs old.

Dr__Ellis: As noted before, I wish I could provide you more information on stem cell research and your condition. You can search www.clinicaltrials.gov for more information on studies. Please also see prior chat transcripts on this topic.


Stem Cells and Heart Valve Disease

Tom_N: Is there any stem cell research being done in the areas of heart valve disease and cardiac arrhythmia?

Dr__Ellis: Almost all the focus of heart related stem cell research done thus far has focused one either relieving angina or improving heart muscle function. There is some evidence from studies in animals to suggest that stem cells may benefit patients with arrhythmias but both stem cell trials for valve disease and cardiac arrhythmias will be in the future.

rfcrow1: I had aortic valve replacement surgery (pig valve) two years ago at 61 and am doing very well. I know that if I'm fortunate enough to live a long life I may have to have another valve replacement procedure. Is there anything coming along in stem cell therapy that may help me avoid another chest cracking surgery?

Dr__Ellis: Stem cell therapy is not very advanced in creating new valves but you should be aware that studies are quite advanced in giving patients new valves with catheters instead of surgery. We had a web chat last week with physicians associated with this trial - you can see the transcript at my.clevelandclinic.org/heart/webchat/default.aspx.


Stem Cell Therapy as Clinical Treatments

Geritol: Realistically, when will stem cell therapy be available for those of us post MI with significant heart muscle damage but not in heart failure?

Dr__Ellis: As I think you can understand treatment with an experimental therapeutic option such as stem cells that may have side effects is usually first evaluated in patients who do not have other good treatment options. Patients with little heart muscle damage after a heart attack usually do not fall into that category. I would say you are looking at a good 6 to 10 years for people who have your condition.

AMilton: I am writing on behalf of my father who is in end stage heart failure. Is there any approved Stem Cell treatment offered in US or is all trial based?

Dr__Ellis: Stem cells are not approved in the US for any indication. Most trials require possible randomization to placebo.

JK23: Has there been any diseases that stem cell therapy has cured?

Dr__Ellis: Stem cell therapy, at least as we are talking about it here, is purely experimental and has not yet been shown to "cure any diseases." However bone marrow transplant for patients with metastatic breast cancer has been very helpful in eliminating cancer cells and improving survival.

soccerfan00: Are they using stem cell therapy in other countries - for example Europe - for treatment of heart failure?

Dr__Ellis: In most countries in Europe, like the US, stem cell therapy is considered experimental. You can go to some countries in Asia to receive stem cell therapy but often times the nature of the stem cells utilized and the outcomes remain poorly regulated.


Stem Cell Therapy and Congenital Heart Disease

metacomputer: My daughter was born with only the left side of her heart; will stem cell help?

Dr__Ellis: At present stem cells have been utilized only to improve blood flow or function of existing muscle although there are animal studies going on attempting to recreate larger structures like your daughter seems to need. Unfortunately I believe it will be many years before we have stem cell therapies to help someone such as your daughter.

metacomputer: what else can we do for my daughter she has a pacemaker defib for VT and she was born with only the left side of her heart she also has liver problems from her heart the doctors at Riley Hospital are sending her records the Cleveland what can your hospital do for her?

Dr__Ellis: Without seeing your daughter's records it is hard to speculate what our physicians can do. It sounds as though your daughter has a relatively rare condition and these are best treated at large centers with experience treating congenital heart defects such as ours. I would suggest you contact Dr. Sterba who has experience with pediatric arrhythmias.


Stem Cell Therapy and Arrhythmias

AMilton: what are the findings with stem cells to repair heart muscle in someone in A-fib?

Dr__Ellis: The fact that someone has atrial fibrillation slightly limits the equipment we can use to inject stem cells, but does not preclude it altogether. It may affect your eligibility for some trials.

AMilton: other than improved EF are their other measurables / outputs of these trials? For example has stem cell treatment been shown to decrease the amount of PVCs a patient has?

Dr__Ellis: There is at least one clinical trial showing a decrease in PVCs.


Ejection Fraction

vikram: HOW LONG AFTER I RECEIVE MY STEM CELL (FROM MY BONE MARROW0 CAN I EXPECT TO SEE RISE IN EF

Dr__Ellis: This depends a little on the nature of the stem cell used but usually 2 - 3 months.

SUZ666: what does LVEF mean and how do I find out my percentage?

Dr__Ellis: LVEF is the left ventricular ejection fraction which is the percentage of blood squeezed out of the heart with every beat. Normal is 55 - 70%. You can find your Ejection fraction (EF)using echo, nuclear scan or MRI.

Cleveland_Clinic_Host: If you have additional questions, please go to clevelandclinic.org/health/livepersonchat to chat online with a health educator.

Dr__Ellis: Thank you for having me.

vikram: THANK YOU

Reviewed: 10/10


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