Archive for the ‘Adult Stem / Cell Treatment’ Category
Share Our Mission to Heal
Holy Cross Hospital is seeking studio audience members for A Mission to Heal, a new show all about the heart.
Needed: 75 audience members for each show; Mix of demographics. No children under 18; Community groups are encouraged to have representation in the audience, as well as community leaders.
Where
A studio in Davie, FL. Details will be provided to audience members upon selection.
When
September 30, 2010; Refreshments will be served.
The show is not “live” but it is being recorded “live” so it will be edited and shown at a later date. Audience members should dress comfortably for long periods of sitting. No white blouses, shirts, hats or sweaters.
Please email info@holy-cross.com and put A Mission to Heal in the subject field OR call 954-776-3244 if you are interested in being part of the studio audience.
Please provide your full name, phone number, e-mail address, age range (20s, 30s, 40s, 50+) and race/ethnicity. Someone will be in touch to let you know if you have been selected and provide additional information.
Vote for the Blog of the Year
Did Dr. Niederman post a blog in 2009 that you found particularly helpful? Was there a blog that you could not wait to share with someone else? We’d love to receive your feedback.
Please comment on what you think was Dr. Niederman’s best blog in 2009.
Adult Cell Treatment Looks into Healing Heart Muscle after Myocardial Infarction
As discussed in my blog of July 16, 2009, researchers at Cedars Sinai Heart Institute in Los Angeles have devised a way to use adult autologous (meaning they come from the person who is receiving them) cardiac cells. They have now reported the first in man use in a study they are conducting with sponsorship from the National Institute of Health.
This study will utilize 24 patients who have had a myocardial infarction followed by emergency rescue angioplasty. They were left with severely impaired heart muscle. They undergo MRI scanning and then a biopsy of their heart through a vein. It is a simple procedure. The cells are then processed in their lab for four to six weeks. 12 million to 25 million are then put back into the heart by injecting them into the artery, which caused the heart attack but is now open because of the previous angioplasty. 6 months later, a second MRI will be done for comparison.
These cells known as cardiosphere-derived cells are very exciting. As in all studies more questions will be raised than answered, how best to administer the cells, by artery or direct injection into the area of heart muscle damaged? What is the proper timing? Can the cells be processed more quickly?
The important point is that this work is being done and cell based therapy is a promising avenue to allow the heart to heal itself. We are proud to be one of the few places in the United States working in this field. I will continue to blog frequently about it.
The Importance of Bone Marrow Cell Therapy
An important stem cell therapy article was published June 16, 2009 in the Journal of the American College of Cardiology 2009; 53:2262-9. This study, the BALANCE study, used bone marrow cell (BMC) therapy to reduce the size of myocardial infarctions.
If you want to limit the size of your heart attack, go as quickly as possible to a hospital like Holy Cross that has a 24-hour team of interventional cardiologists who will quickly open the occluded artery. The goal is to have the artery open 90 minutes after you arrive. The best results are seen in those patients that arrive early. After the heart attack, we have no current options for fixing the damaged muscle. We treat the heart with medication to improve its strength, but we have no way to treat the actual muscle damage.
This study done from 2002 to 2003 in a single center in Germany now reports their 5-year data. A total of 62 patients were treated and 62 control patients were matched in the group that refused therapy. These patients underwent standard emergency angioplasty and then 7 +/- 2 days later had autologous bone marrow cells infused down their infarct related artery. These cells are harvested from the patient in the standard way and then processed to remove the red blood cells.
Long term survival analysis shows that BMC therapy reduces mortality in treated patients with no long-term side effects. In the treated group, it was 0.35%/year and in the control group 2.35%/year. The five year mortality was 1.6%. Published reports that analyze long-term mortality in patients with myocardial infarction range from13 to 24% after five years.
This study is small and nonrandomized. In an accompanying editorial it is put into perspective. Presently the search is on for better cells. At present it is possible to take skin fibroblasts and reprogram them by inserting specific transgenes into the fibroblast nucleus. These cells are referred to as induced pluripotent stem cells (iPS). They can be further altered by proteins that regulate the development of cardiac cells. The result can produce beating cardiomyocytes. These cells could then be implanted.
As I have discussed before, it is difficult to biopsy the heart and derive enough useful cells. This now may have been overcome by a process that cultures the biopsy material which is then harvested to form multicellular structures called cardiospheres. These are referred to as cardiosphere-derived cells (CDC). These cells are set to be applied in a first in human study to be done at Cedars-Sinai Medical Center.
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NOGA and Protein Combine to Beat Angina
Our team has begun enrolling participants in our third stem cell therapy trial. This trial is unique in many ways.
First and foremost, we will be utilizing the NOGA machine to restudy patients at the study’s conclusion. At this time, we will obtain some very unique data not usually collected on participants. Most of the “success” of trials for heart failure and angina depends on a decrease in the symptoms that the patient had at the study’s start. Treadmill and walking tests are also used. However, the NOGA enables us to revisit the exact sites of injections so those areas of heart muscle can be analyzed for improvement in blood supply and movement.
The second unique part of this study is it does not use cells but rather a manufactured human protein which has been altered slightly. This protein is understood to provide stimulation of the growth of new blood vessels and of new muscle. This may allow those patients that need this type of therapy to not have to endure the arduous and expensive process of harvesting the cells from each donor. The manufactured protein can go in any patient without concern for rejection.
Like the BAXTER study before it (see blogs on 06-25-09 and 06-29-09), this study is enrolling patients who are limited by their angina and have failed medical management and are not angioplasty or coronary bypass candidates.
Candidates must walk on the treadmill and qualify, then undergo catheterization and nuclear stress testing. If they pass all the qualifying tests, they are then injected by NOGA mapping with either active protein or placebo. This is a safety study and does not have the statistical power to determine whether the treatment works or not. We know from other work that patients can have marked benefit. You will soon be able to hear some of these patient success via video on our website toward the end of the summer.
If you have angina and would like to discuss treatment options with us further, we can be reached at 954-229-8400.
Getting a Leg Up on Heart Failure
Heart failure has reached epidemic proportions in the United States owing to our aging population and the advances in treating myocardial infarctions. Over 5 million people carry the diagnosis and 550,000 new cases a year occur. In 2001, there were nearly 1 million hospital discharges.
We have multiple therapeutic options which include angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta blockers, cardiac resynchronization, diuretics and since the 1700s, digitalis. Now the latest innovation, stem cell injections.
Bioheart is a biotech company located in Sunrise, Florida. They have developed a process to find and grow skeletal muscle stem cells. We do not yet have a process to biopsy and grow cardiac stem cells. There are several very early stage studies in Europe with progenitor cardiac stem cells but they are still in pilot stage. Bioheart’s Marvel study is the third and final step to FDA approval of these cells for the treatment of congestive heart failure. A pilot study and a safety study showed that this treatment was safe with a robust trend to effective. In fact, the first 20 patients of the third study - of which three are from our site - have been studied and also found to have a robust effect.
The process involves taking a biopsy from the leg muscle of patients. This is then sent to Bioheart and processed to find the 6-8 fibroblast stem cells in the biopsy specimen. These cells are then grown out and in 14-21 days become billions of cells. These cells are then given to me to inject in the heart after NOGA mapping shows me the appropriate place. See the blogs of June 22 and / or 29 for details of the NOGA procedure.
We are proud to be the only team in South Florida doing this important work. The study will open for enrollment again in the Fall and we look forward to helping our patients with this technique. Please feel free to contact us for more information at 954-229-8400.
Using the body to heal the body
ACT34-CMI was a Baxter stem cell study to improve a patient’s collateral blood flow to the heart muscle. It utilized adult stem cells derived from the patient’s bone marrow. The patient had their bone marrow stimulated by a drug know as Neupogen. This drug is often used in cancer patients as their white blood cells are destroyed by the chemotherapy. The patient receives drug injections on five consecutive days and then their CD34+ cell levels are measured in a peripheral blood draw. If their levels are high enough, the patient moves on.To collect the cells, the patient then undergoes a process similar to hemodialysis. They are placed on a machine which removes all their blood and filters the white blood cells. After 5-6 hours, enough has been collected. This bag of cells then begins the process of separating the CD34_+ cell type from all the other cells.
This is the process being approved in this study. Using a special reagent, a nano particle is attached to just the CD34+ cells. This is done by utilizing the special markers which are denoted CD34+. After the cells are marked, they are placed in a separator and then over several hours the CD34+ cells are purified until only they exist and the rest of the white blood cells are on the other side.
The cells are then placed in another reagent and the nano particles separate from the cell leaving a pure specimen of CD34+ cells. It is this specimen or placebo (yes some people go through the whole process just to get placebo) which I am handed in the cardiac catheterization lab to inject.
In the cardiac cath lab I use the machine called NOGA to isolate the areas of the heart that are alive but lacking blood supply. We also have nuclear stress test images to guide us. Once these areas are located a special catheter is inserted through the leg artery and placed in the heart. The area is localized and then a tiny needle is extended out into the heart muscle. The material is then injected. A total of ten injections are made close to each other. The cath lab process takes about 2 hours.
All of the cell therapy projects are done in the same way, with the exception of the method used to derive the specific product we are looking to inject.
Next…cell therapy for congestive heart failure.
Adult Stem Cell Research
NOGA mapping image
One of the primary purposes for the creation of the JMHVRI was to have Holy Cross Hospital involved with cutting-edge research. This has allowed us to participate in the most exciting research development in years.
In my 20 years of research at the clinical level, my team and I have had the privilege of being involved with important breakthroughs in the clinical and drug treatment of cardiac disease. We have participated in the development and approval process of most of the drugs I now use for the treatment of heart disease. Much of our work continues in this mode. Our work with adult stem cells portends an improved future for cardiac patients.
To date, we have been involved with two stem cell projects and one project utilizing a stem cell protein. We are the only site in south Florida and one of three sites in Florida.
Adult stem cells are undifferentiated cells that multiply by cell division to replenish dying cells and regenerate damaged tissue. They are derived from adult tissue samples. Although the process is unique, it is not strong enough to repair all the cells that die naturally or by accident. If you have a heart attack, the few adult cardiac stem cells in your heart are not numerous enough to repair the damage. The reasons are unknown and an active area of research. We have no way of obtaining adult cardiac stem cells because we cannot biopsy the heart adequately to obtain them.
Therefore, the studies utilize other stem cells to obtain the results we are clinically trying to obtain. These cells or protein material are then injected directly into the heart from the leg in a manner similar to angiography and angioplasty using an additional special machine known as NOGA. NOGA technology is similar to the technology used in electrophysiology studies to isolate and identify areas of the heart of interest; in our case, those areas of the heart which are scarred or lacking adequate blood supply. After identification, special catheters are used for the injections.
Next… The Baxter CD34+ stem cell study for the treatment of angina.
Blog Dedicated to Research Launched
Welcome to the JMHVRI blog. My purpose in hosting this blog is to be personal and educational. I will strive to bring the practice of cardiology and the groundbreaking research that my colleagues and I do to your attention. We are here for our community as Holy Cross and the Sisters of Mercy have been for over 50 years.
Heart disease is the leading cause of death in the United States for both men and women. Much has been learned over the past years but significant issues still remain. Information is now widely available on the Internet but much of it requires interpretation and some is just incorrect. This site will be a place to discuss these issues and concerns.
The JMHVRI is involved in groundbreaking research. We are the only site in South Florida for some of this work. I will highlight these studies so that you can participate or pass the information on to others who might be in need.
Our research institute is currently working on Adult Stem Cell therapy for the treatment of angina which can not be remedied with medication, surgery or angioplasty and as a treatment for heart failure which is still problematic in spite of all known therapies.
We are working on new therapy to replace Coumadin, as well as a new class of drugs known as Thrombin inhibitors for the treatment of clots. On new ways to treat high cholesterol, on new treatments for heart attacks, on novel drugs for the treatment of congestive heart failure to name just a few of our projects. I will inform you in depth about all these projects and more.
It is an exciting journey and I welcome you to join me.
About the Institute
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