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Jul 27, 2009 03:45 PM | 15
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The first person to receive a new cardiac stem cell treatment in a U.S. Food and Drug Administration clinical trial is doing well, it was announced last week.
On Friday, doctors at the University of Louisville School of Medicine, in collaboration with the nearby Jewish Hospital, issued a press release stating that one week after treatment, Mike Jones’s heart was getting stronger.
Jones, whose heart tissue is permanently scarred and weakened by two previous heart attacks, suffers from congestive heart failure, a condition affecting about five million Americans each year, according to the National Institutes of Health.
Currently, two treatment options predominate for patients with heart failure, said Mark Slaughter, a cardiovascular surgeon who aided in the trial. A person can receive a heart transplant or a mechanically assisted heart device.
The new approach, using a patient’s adult stem cells to regenerate healthy heart tissue, is currently in phase I clinical trials to test for safety. The procedure consists of removing healthy heart tissue from the patient, purifying the stem cells from the material, and allowing the stem cell population to grow. Once ready, the stem cells are reintroduced into the scarred region of the heart using a minimally invasive technique.
Since the re-injection of his own stem cells on July 17, Jones’s heart has increased its ability to pump blood by about 5 percent. Jones commented in the University of Louisville School of Medicine press release that he felt so good he might “even start jogging again.”
The doctors will continue monitoring Jones every few months for the next two years to measure his recovery. There are currently 13 more patients going through the phase I trial, and the researchers hope to eventually test a total of 20 patients.
Last month, a group at the Cedars-Sinai Heart Institute in Los Angeles made news with a similar technique that was undergoing clinical trials. Instead of using purified stem cells, the group is using a mixture of cells, including stem cells, to regenerate heart tissue. Ken Miles, the first patient to receive the treatment, told CBS’s The Early Show that he “feels great.”
Image of heart model by ericsphotography via iStockphoto
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15 Comments
Add CommentWhat about an artificial heart? In early September 2006, there were two articles in the New York Times announcing that the company, Abiomed, expected to produce a fully implantable artificial heart which could operate for five years. It was expected that the "Abiocor II" (the product's name) would be available by 2008. Does anyone know whether this product is by now available to the public?
Reply | Report Abuse | Link to thisInteresting question Phil72, I'd like to hear about that too, although regenerating your own real heart sounds like a much better solution than putting in an artificial one...
Reply | Report Abuse | Link to thisAastrom Biosciences (ASTM) is in phase 2 trials at 4 prime hospital sites.
Reply | Report Abuse | Link to this"To date, 14 of 40 patients have been enrolled in the IMPACT-DCM trial at the first three clinical sites: The Methodist DeBakey Heart & Vascular Center, Houston, TX, Baylor University Medical Center, Dallas, TX and The University of Utah School of Medicine, Salt Lake City, UT. In addition, the fourth and fifth sites, Cleveland Clinic Heart & Vascular Institute in Cleveland, OH and Emory University Hospital Midtown in Atlanta, GA, were recently initiated and trained for participation in the IMPACT-DCM clinical trial.
They are only treating the most critically ill patients that University of Louisville will not touch with a 10 ft pole... But these clinical trials are not getting as much attention. I wonder why?
Reply | Report Abuse | Link to thisSource: Aastrom Biosciences, Inc.
Aastrom Proactively Places Phase II IMPACT-DCM Clinical Trial On Hold Following Report of Serious Adverse Event
Treatment Patient Released From Hospital Later Dies; Investigation Underway to Determine Cause of Death
ANN ARBOR, Mich., May 22, 2009 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of autologous adult stem cell treatments for severe chronic cardiovascular diseases, today announced that the Company has temporarily suspended enrollment and patient treatment in its U.S. Phase II IMPACT-DCM clinical trial following a report that a patient died at home after being released from the hospital following treatment in the trial. The patient's cause of death has not yet been determined and is the subject of a pending investigation at the clinical site. An independent Data Safety Monitoring Board (DSMB) will also assess the circumstances of the event.
In accordance with standard operating procedures, the Company has informed the U.S. Food and Drug Administration (FDA) of the following: the death of the patient after being released from the hospital; the initiation of an investigation into the cause of death; and that the Company has voluntarily suspended patient enrollment and treatment in the trial. Subsequently, the FDA placed the trial on temporary clinical hold pending an investigation. Follow-up of patients previously enrolled in the IMPACT-DCM trial will continue in accordance with study protocol.
"Patient safety has been and continues to be our primary concern," stated Elmar R. Burchardt, M.D., Ph.D., Vice President, Medical Affairs at Aastrom. "We will continue to work closely with the trial site, the DSMB and the FDA to review the events surrounding the death of one of the patients in this clinical trial. We remain committed to ensuring patient safety and will work to resume patient enrollment and treatment in the IMPACT-DCM trial as soon as possible."
Upon completion of the investigation, Aastrom will work closely with the FDA to provide any information required in order to expedite its review and to resolve this matter so that patient enrollment into the IMPACT-DCM trial can resume as soon as possible. Aastrom will provide updated guidance regarding projected patient enrollment once the FDA has made its determination.
IMPACT-DCM is the first clinical trial in the U.S. to evaluate the surgical delivery of autologous cells directly into the human heart muscle for the treatment of congestive heart failure associated with dilated cardiomyopathy (DCM) in both ischemic and non-ischemic patients. Patients randomized into the treatment group of the IMPACT-DCM trial are treated with Aastrom's Cardiac Repair Cells (CRCs), an autologous, mixed-cell product containing expanded populations of stem and early progenitor cells produced from a small sample of the patient's own bone marrow.
DCM is a condition where enlargement of the patient's heart reduces pump function, making it impossible to maintain normal blood circulation. Patients with DCM typically have symptoms of congestive heart failure, including severe limitations in physical activity and shortness of breath. DCM generally occurs in patients who have ischemic heart failure due to multiple heart attacks, though it can also be found in patients with non-ischemic heart failure caused by hypertension, viral infection or alcoholism. Patient prognosis depends upon the stage of the disease but is typically characterized by numerous health problems and a very high mortality rate.
About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue. The Company's proprietary Tissue Repair Cell (TRC) technology involves the use of a patient's own cells to manufacture products to treat a range of chronic diseases and serious injuries. Aastrom's TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. The Company's ongoing development activities focus on applying TRC technology to cardiac and vascular tissue regeneration. The Company is currently focused on cardiovascular regeneration through a Phase II clinical trial with dilated cardiomyopathy (DCM) patients (the IMPACT-DCM trial) and a Phase IIb clinical trial with critical limb ischemia (CLI) patients (the RESTORE-CLI trial).
The Aastrom Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3663
For more information, visit Aastrom's website at www.aastrom.com.
This document contains forward-looking statements, including without limitation, statements concerning planned clinical trials and activities and anticipated timing of clinical events, product development objectives, and potential product applications, which involve certain risks and uncertainties. The forward-looking statements are also identified through use of the words "expected," "anticipated," "planned," and other words of similar meaning. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are potential patient accrual difficulties, clinical trial results, potential product development difficulties, the effects of competitive therapies, regulatory approval requirements, the availability of financial and other resources and the allocation of resources among different potential uses. These and other significant factors are discussed in greater detail in Aastrom's Annual Report on Form 10-K and other filings with the Securities and Exchange Commission.
CONTACT: Aastrom Biosciences, Inc.
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Adult stem cells are the way to go, The FDA needs to be more open to this type of science. I think you might find this information very interesting www.adultstemcellsrelease.com
Reply | Report Abuse | Link to thisThanks,
Ray
Ray, I checked the website you suggested for more information and I have my reservations. It sounds too commercial and not scientific, Plus, in your remarks, you totally ignored the fact that a patient died after treatment with autologus cells. Let the FDA complete its investigation before calling to let this treatment to continue. Better be cautious then sorry. Lets learn from past experience
Reply | Report Abuse | Link to thisWhen I read the news and the comments I am reminded of a traditional medicinal practice prevalent among the sidha-system practitioners,which consists of using the heart and lungs of young goats together with some medicinal herbs having a traditionally and empirically proven effect on cardiac functions,to prepare an alcohol extract of the concoction. This extract,known as cardiac broth is given to people with deficient heart functions and weakened cardiac muscles to restore the vigour and strength,quite effectively,and in a short time. This appears to be safer than the stem cell treatment,if one goes by the comments and related reports.
Reply | Report Abuse | Link to thisSURESHKUMAR.S,SCIENTIST AND ADVISER,NIIST[CSIR]
While this is indeed a victory; it is also very sad that the US is so far behind the rest of the world in stem cell treatments.
Reply | Report Abuse | Link to thisTo make matters worse, they are now bragging about being the first? Wow. Such audacity.
For the record, he is not the first. Not even close. In fact...
Adult Stem Cells have been used to treat cardiac disease around the world for 5 years AND there have been many clinical trials in the US prior to this one.
Here's the proof:
http://repairstemcell.wordpress.com/2009/07/29/first-ever-stem-cell-heart-patient/
While this is indeed an adult stem cell victory; it is also very sad that the US is so far behind the rest of the world in stem cell treatments.
Reply | Report Abuse | Link to thisTo make matters worse, they are now bragging about being the first? Wow. Such audacity.
For the record, he is not the first. Not even close. In fact...
Adult Stem Cells have been used to treat cardiac disease around the world for 5 years AND there have been many clinical trials in the US prior to this one.
Here's the proof:
http://repairstemcell.wordpress.com/2009/07/29/first-ever-stem-cell-heart-patient/
I assume that an injection of stem cells ( I'm also assuming that is how this procedure is done as it says they are "reinjected") would be much more suitable to people instead of replacing the entire heart.
Reply | Report Abuse | Link to thisAutologous stem cells are by definition "from the patients own body" so they are in fact, extracted and then reinjected. SO the "reinjected" means they were inside the body previously.
Reply | Report Abuse | Link to thisThere are a number of different ways to inject stem cells into or around the heart. These techniques are improving all the time. The heart is not a "solid mass" organ like the liver or pancreas so you can't inject into the center of it and regardless of technique, some spillage into the circulatory system occurs.
But that's not entirely bad. In many cases (about 50% in one study), heart disease patients who also have diabetes (they often go together), have halved or completely gone off of their insulin medication after cardiac stem cell treatment. Turns out, the spillover cardiac stem cells somehow repair the pancreas.
Adult stem cells do have a proven history of benefit for congestive heart failure patients (those waiting for a heart transplant and the lesser levels of heart disease) and they are, in many cases, better than the heart transplant option and do not require surgical intervention, immunosuppressive drugs, etc.
Adult stem cells hae been used in other countries for several years. The FDA just wants total control to help the drug companies sell more drugs. We need freedom of medical choice so we don't have to leave this country to get the care we want. I'm getting new lung cells with a natural product. We need to have options.
Reply | Report Abuse | Link to thisIn June the FDA cleared Aastrom of responsibility for the death of a patient. As Reuters reported: "The FDA, the clinical site's principal investigator and an independent Data Safety Monitoring Board (DSMB) attributed the patient's death to progression of the disease and determined it was unrelated to the CRC treatment, Aastrom said."
Reply | Report Abuse | Link to thisIt's true that US progress in stem cell treatments have been stymied by the FDA. Several years ago, it was the Texas Heart Institute that worked with Brazilians and published the awesome results of treating terminal heart patients with their own stem cells. A few years ago, a British citizen went to Germany to have his heart repaired with his own stem cells and started an effort to make it available in England.
Obviously cardiologists would suffer loss of income if this much safer, easier procedure replaced bypasses and heart tranplants. Last year the FDA, in a brazen step to protect the profts of interested groups, decided that a person's own stem cells must be treated as drugs.
The difference between the Louiseville trial and previous ones is that the doctors go in and snip off a piece of the heart. The other procedures aspirate stem cells from the bone marrow. The Louiseville procedure has the possibility of patents and royalties.
Unfortunately you always have to follow the money. Below is an excerpt from Germany's Xcell Center, which is currently treating heart patients with adult stem cells. As they point out, thousands of patients around the world have already been helped with the treatment...but not here.
Bone marrow stem cells have been used to treat thousands of heart patients around the world. Autologous adult bone marrow treatments are the focus of dozens of promising clinical trials in the United States, Europe, Japan and South America.
The XCell-Center in Cologne, Germany is the first privately-owned center in Europe to specialize in regenerative medicine using autologous bone marrow adult stem cell therapy. The XCell-Center in Dusseldorf, Germany has been inaugurated in January of 2009. Both XCell-Center facilities feature the latest medical equipment and technology. They boast a specialized medical team of German physicians includes: neurologists, endocrinologists, cardiologists, radiologists, hematologists, and pharmacologists.
The XCell-Center works in accordance with German law and European guidelines. The XCell-Center currently treats Diabetes and its complications (Erectile Dysfunction and Peripheral Artery Disease), different eye diseases,
clinical studies using one's own stem cells have been going on for 5 years or longer in this the usa (eg. see Dr Patel, Univ. Pittsburgh and now at the salt lake utah heart clinic plus many other clinical studies promoted by the FDA). of course other countries around the world have been doing this procedure and are way ahead of the usa.
Reply | Report Abuse | Link to thisthis does not mean it is a panacea. much more study and fda approval are needed from what i read on the matter. however, people such as myself with a weak heart pump and congestive heart failure (chf) are on a different time line...so hurry.
also, just read an article here on line regarding a study using rats where the study includes extracting the rats own stem cells from the heart and
regrow the stem cells on a biodegrdable mesh patch and subsequently attach the patch to the damage part of the heart. the main premis here is that the use of one's own stem cells from other parts of your body, then purified and then injected into the heart is inefficient. most of the stem cells don't survive (see on line article www.scientificamerican.com/article.cfm?id=patches-repair-damage-hearts&print=t an article written by katherine harmon dated august 24, 2009 Scientific American, Researchers design patches of cells to repair damage hearts). this kind of puts the kibosh on all of the clinical studies now carried on by the fda.
however, i did talk to a chf patient recently, on line.. she had the stem cell procedure done by a U. S. doctor in south america using her own adult stem cells from her bone marrow. cost her $40,000 or so. she is very happy with the results so far.
Want an update on applications? Wide range with no adverse effects. Check X-Cell.com in Germany.
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