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Category Archives: Alabama Stem Cells

Can cancer vaccines prolong survival?

Posted: April 7, 2015 at 6:59 pm

IMAGE:Cancer Biotherapy and Radiopharmaceuticals, published 10 times per online with open access options and in print, is under the editorial leadership of Co-Editors-in-Chief Donald J. Buchsbaum, PhD, Department of Radiation... view more

Credit: Mary Ann Liebert, Inc., publishers

New Rochelle, NY, April 6, 2015--Therapeutic anti-cancer vaccines developed to treat metastatic disease such as advanced prostate cancer or melanoma rarely have a noticeable effect on the tumor but have been associated with a statistically significant increase in patient survival. Robert O. Dillman, MD, NeoStem, Inc., asserts that "overall survival" rather than "progression-free survival" should be the gold standard for evaluating the efficacy of cancer vaccines in clinical trials, in a provocative new article published in Cancer Biotherapy and Radiopharmaceuticals, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free on the Cancer Biotherapy and Radiopharmaceuticals website until May 6, 2015.

In the article "Cancer Vaccines: Can They Improve Survival?" Dr. Dillman differentiates between the two key endpoints typically used to assess therapeutic cancer vaccines in clinical studies. As cancer vaccines are designed to stimulate an immune response to cancer cells and induce long-term memory recognition of a tumor, they may improve overall survival even if they do not appear to slow the progression of disease. Although measuring overall survival compared to progression-free survival would usually require longer clinical trials, overall survival may be the only relevant efficacy endpoint, the author concludes.

"This is a timely article considering the number of vaccine and antibody immunotherapy trials ongoing or planned," says Co-Editor-in-Chief Donald J. Buchsbaum, PhD, Department of Radiation Oncology, Division of Radiation Biology, University of Alabama at Birmingham. "The conclusion that overall survival is the best clinical endpoint for efficacy in therapeutic vaccine and antibody immunotherapy trials in patients with metastatic cancer is based on an analysis of four completed trials."

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About the Journal

Cancer Biotherapy and Radiopharmaceuticals , published 10 times per online with open access options and in print, is under the editorial leadership of Co-Editors-in-Chief Donald J. Buchsbaum, PhD, Department of Radiation Oncology, Division of Radiation Biology, University of Alabama at Birmingham, and Robert K. Oldham, MD, CAMC-Teay's Valley Cancer Center. Cancer Biotherapy and Radiopharmaceuticals, celebrating 30 years in 2015, is the only journal with a specific focus on cancer biotherapy, including monoclonal antibodies, cytokine therapy, cancer gene therapy, cell-based therapies, and other forms of immunotherapy. The Journal includes extensive reporting on advancements in radioimmunotherapy and the use of radiopharmaceuticals and radiolabeled peptides for the development of new cancer treatments. Tables of content and a sample issue may be viewed on the Cancer Biotherapy and Radiopharmaceuticals website.

About the Publisher

Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Journal of Interferon & Cytokine Research, Human Gene Therapy, and Stem Cells and Development. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN) (http://www.genengnews.com), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 80 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.

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Human embryonic stem cells clinical trials – Wikipedia …

Posted: February 19, 2015 at 10:59 pm

Human Embryonic Stem Cell Clinical Trials[edit] Introduction[edit]

The Food and Drug Administration (FDA) approved the first clinical trial in the United States involving human embryonic stem cells on January 23, 2009. Geron Corporation, a biotechnology firm located in Menlo Park, California, originally planned to enroll ten patients suffering from spinal cord injuries to participate in the trial. The company hoped that GRNOPC1, a product derived from human embryonic stem cells, would stimulate nerve growth in patients with debilitating damage to the spinal cord.[1] The trial began in 2010 after being delayed by the FDA because cysts were found on mice injected with these cells, and safety concerns were raised.[2]

In the United States, the FDA must approve all clinical trials involving newly developed pharmaceuticals. Researchers must complete an Investigational New Drug (IND) application in order to earn the FDAs approval. IND applications typically include data from animal and toxicology studies in which the drugs safety is tested, drug manufacturing information explaining how and where the drug will be produced, and a detailed research protocol stating who will be included in the study, how the drug will be administered and how participants will be consented.[3] Testing for new drugs must successfully go through three phases of research before a drug can be marketed to the public. In Phase I trials, the drugs safety is tested on a small group of participants. The drugs effectiveness is tested during Phase II trials with a larger number of participants. Phase III trials, involving 1,000- 3,000 participants, analyze effectiveness, determine side effects and compare the outcomes of the new drug to similar drugs on the market.[4] An additional phase, Phase IV, is included to continually gain information after a drug is on the market. Gerons IND application for the GRNOPC1 clinical trial, nearly 28,000 pages in length, was one of the most extensive applications ever to be submitted to the FDA.[2]

Before Geron could test GRNOPC1 in humans, tests in animals had to occur. At the University of California at Irvine, Dr. Hans Keirstead and Dr. Gabriel Nistor, credited with the technique used to develop oligodendrocytes from human embryonic stem cells, injected the cells into rats with spinal cord injuries. The condition of the rats improved after treatment.[5]

The first patient, identified in an article by the Washington Post as Timothy J. Atchison of Alabama, enrolled in the trial in October 2010. The patient was treated at the Shepherd Center in Atlanta, GA just two weeks after he sustained a spinal cord injury in a car accident. The Shepherd Center and six other spinal centers were recruited by Geron to participate in the clinical trial. The Washington Post reported that Atchison has begun to get some very slight sensation: He can feel relief when he lifts a bowling ball off his lap and discern discomfort when he pulls on hairs on some parts of his legs. He has also strengthened his abdomen. Atchison underwent therapy at the Shepherd Center for three months before returning home to Alabama.[6]

Although Geron initially aimed to enroll ten patients in the trial, only three additional patients were added after Atchison. As specified by Geron, eligible patients had to experience a neurologically complete spinal cord injury within seven to fourteen days prior to enrollment. In addition, patients had to be between the ages of 18 and 65 and could not have a history of malignancy, significant organ damage, be pregnant or nursing, unable to communicate or participate in any other experimental procedures. Participants received one injection of GRNOPC1 containing approximately 2 million cells. Even though the trial has officially ended, Geron will continue to monitor participants for fifteen years.[7]

Although no official results from the trial have been published, preliminary results from the clinical trial were presented at the American Congress of Rehabilitation Medicine (ACRM) conference in October 2011. None of the participants experienced serious adverse events, although nausea and low magnesium were reported. In addition, no changes to the spinal cord or neurological condition were found.[8]

After investing millions of dollars in the research leading up to this trial, Geron Corporation discontinued the study in November 2011 to focus on cancer research. John Scarlett, Gerons chief executive officer, said In the current environment of capital scarcity and uncertain economic conditions, we intend to focus our resources on advancing our two novel and promising oncology drug candidates.[9] The companys stocks fell dramatically to $1.50 per share from $2.28 per share when news of the trials discontinuation became public. A spokesperson for the company said that Geron would save money by ending the trial despite the loss in investors. Because many believed Gerons trial offered hope for advancing knowledge related to stem cells and their potential uses, there was disappointment in the scientific community when the trial was cut short. An article on Bioethics Forum, a publication produced by The Hastings Center, stated, "It is one thing to close a trial to further enrollment for scientific reasons, such as a problem with trial design, or for ethical reasons, such as an unanticipated serious risk of harm to participants. It is quite another matter to close a trial for business reasons, such as to improve profit margins."[10]

In 2013 Geron's stem cell assets were acquired by biotechnology firm BioTime, helmed by CEO Michael D. West, the founder of Geron and former Chief Scientific Officer of Advanced Cell Technology. BioTime indicated that it plans to re-start the embryonic stem cell-based clinical trial for spinal cord injury.[11]

Two clinical trials involving derivatives of human embryonic stem cells were approved in 2010. Advanced Cell Technology (ACT) located in Marlborough, Massachusetts, leads the trials aimed at improving the vision of patients with Stargardts Macular Dystrophy and Dry Age-Related Macular Degeneration. Originally, twelve patients were estimated to enroll at three hospitals in the U.S.; participating institutions included the Casey Eye Institute in Portland, Oregon, University of Massachusetts Memorial Medical Center in Worchester, Massachusetts, and the New Jersey Medical School in Newark, New Jersey.[12] Patients eyes were injected with retinal pigmented epithelial cells derived from human embryonic stem cells. While no definitive findings from this study have been produced, an article published in Lancet in January 2012 stated that preliminary findings appear to be promising. In this article, outcomes from two patients treated as part of the trial were discussed. During the trial, neither patients vision worsened, and no negative side effects were reported.[13]

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Christian singer Carman shares testimony of cancer victory

Posted: February 2, 2015 at 6:00 am

(Photo: Facebook/Carman)

Carman during and after cancer treatment.

Platinum recording artist Carman shared before and after photos with his Facebook fans on Tuesday following his successful cancer treatment.

Carman, born Carmelo Licciardello, was diagnosed with myeloma in February 2013, and given only a few years to live. This week, he reflected on how far he has come, and thanked God that he remains cancer-free.

"I remember so well washing my hair after the 3rd week of chemotherapy and seeing it all come off in my hands in clumps," Carman wrote. He shared a photo of himself bald and receiving chemo juxtaposed with a photo of himself nine months later, healthy and with a full head of hair.

"I remember the agony of that giant needle in my sternum to draw out stem cells," he continued.

"The ports they planted in my chest to daily inject drugs. The mind numbing pain of my bones expanding to produce stem cells. Sleeping in the bathroom for days because I'd throw up so often."

The singer also detailed the extreme weight loss and weight gain he experienced while receiving chemotherapy, and nearly dying after catching pneumonia. Through it all, Carman said he never questioned God.

"But I also remember God's grace," he said. "I remember never getting angry or depressed. Never feeling abandoned or hopeless. It was the valley of the shadow of death but I feared no evil."

Now, the 59-year-old is "strong and cancer free," and gearing up for the second leg of the "No Plan B" tour which begins in Alabama on February 12. He encouraged others to put their faith in God when they face trials.

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Urban Dictionary: stem cell

Posted: January 21, 2015 at 3:00 pm

a stem cell is a cell whose function has not been decided. stem cells have the potential to become any type of cell that exists, at least in humans. every person has stem cells, but the older you are, the harder it is to find these cells, because less of them exist. the most easy place to get these cells from is the BLASTOCYST form of fetal development; herein lies the bige controversy of embryonic stem cell research

an example is someone who has diabetes. this disease causes cell in the pancreas to stop functioning and eventually die. stem cells have the potential to repair the problem before it even happens.

Cells that maintain the ability to replicate them selves as well as form other cells of the body. Two major classificiations exist; embyronic stem cells which are totipotent or pluripotent and can make any cell of the organisms body and adult or tissue specific stem cells which are multipotent and can produce only a limited range of cell types. Often confused by the laymen and stupid right-wing politicians as tiny little babys but really more similar to dandruff than babys.

this is a more simple definition of it. before the human body developes it has stem cells, which are like blank cells, that will eventually become other things, if stem cells are put next to muscle tissue, it will become muscle tissue etc. you can get them from aborted fetuses and they could cure diseases like alzheimers, because they might beable to put the stem cells in the people, and have them replicate and rebuild the brain cells. and yes, as the other person said "Often confused by the laymen and stupid right-wing politicians as tiny little babys but really more similar to dandruff than babys"

stem cells could save millions of people but republicans wont let that happen

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Huntsville blood bank to preserve umbilical cord tissues

Posted: November 25, 2014 at 5:57 pm

The only umbilical cord blood bank in Alabama will soon carry the tissues as well.

Southern Cord, headquartered at Huntsville's HudsonAlpha, will soon offer the new service, which will allow them to do research for different medical applications that cord blood doesn't have. This is because the tissues contain a different kind of stem cell.

Were storing these cells so that at a future date, they can be used by the baby, but they also could be used by the siblings and even the parents, Southern Cord owner and UAH director of information services Chakri Deverapalli says. Currently, there are already 80-plus diseases cleared by the Food and Drug Administration (FDA) where cord blood is used as a treatment. And this is only the tip of the iceberg, as the field of emerging medicine continues to expand.

Medical research is uncovering treatment roles for cord blood stem cells in diseases like autism, cardiac disorders and Alzheimers disease.

The research shows that one in 70 kids in this generation are going to need stem cell treatment, Deverapalli says. Medicine has changed and so treatment itself is advancing.

The stems cells being saved are not ethically controversial, according to Deverapalli.

Our cells can at most become an organ, he says. They cannot create another life.

The umbilical cord blood is collected by a doctor at birth, transported to the company, processed and cryogenically frozen to temperatures of minus 140 degrees Celsius, which Deverapalli says is about the surface temperature of Saturn.

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CGS : 60 Minutes Exposes Stem Cell Scams Again

Posted: November 22, 2014 at 3:03 am

On Sunday, 60 Minutes aired a horrifying expos of a stem-cell scam. Reporter Scott Pelley made it clear that his team was not just using deception and hidden cameras to incriminate one particular con man (Dan Ecklund, pictured). This was intended as an example, one of "hundreds of credible-looking websites offering stem-cell cures at overseas clinics." Pelley stressed that "there is no stem cell miracle today" and interviewed Duke professor Dr Joanne Kurtzberg, who contradicted numerous claims of cures while holding out hope for efficacy in perhaps ten years.

Ecklund lost his license to practice medicine in Alabama for a variety of offenses, including providing recreational drugs to and having sex with underage patients. He's now based in Ecuador but was lured to Florida, where hidden cameras filmed him.

In a follow-up on Monday, Pelley called the scams "monstrous" and explained that 60 Minutes has been on this story for two years. Back in April 2010, they exposed a similar scam, using similar methods. That program finally led to arrests on December 27, 2011; the indictment alleges that the defendants made more than $1.5 million from patients.

Almost as shocking as the revelations in the program are the comments posted at the CBS website. Some are supportive, but many accuse the program of being sensationalist, and in the pocket of Big Pharma. Several claim to report successful stem cell treatments, and some even accuse Dr. Kurtzberg of misrepresenting the science in order to make profits herself.

The hype about stem-cell cures that was widely promoted for years (remember the 2004 presidential election when John Edwards declared that they would make "people like Christopher Reeve" walk again?) seems to have metastasized into a scandal no responsible scientist would ever have intended or expected. But clearly, in addition to continuing research, a lot of educational work remains to be done. Kudos to the team at 60 Minutes for their efforts.

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Posted inBiotech & Pharma, Media Coverage, Pete Shanks's Blog Posts, Stem Cell Research

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What Are Stem Cells? (with pictures) – wiseGEEK

Posted: November 16, 2014 at 10:57 pm

anon268549 Post 7

Even if stem cell research progresses for the purpose of medical treatment and repair, it is inevitable that with the technology handy, some private research groups (and probably quite a few billionaires) will make attempts at using them to clone legally or not. I mean hey, if you had an extra billion dollars lying around would you not use it to make a clone of yourself?

I think that stem cells are great they will (I can guarantee you) help us in the near future in the curing of diseases and broken tissue or muscles.

I wish I would have known more about stem cells before I had my children. I had heard about people saving stem cells from their baby's umbilical cords, but all I really knew about it was that it costs a lot of money to store the cells year after year, so I never did it.

Now that I know more about it, though, I wish I would have done it. If something were to happen to one of my children, and the use of stem cells could save them, that is invaluable. If only I could go back in time and save them, because I won't be having any more babies.

But, with all of the research being done on adult stem cells, maybe that's all we'll need someday.

I've heard about all of the stem cell debate, but if something was wrong with your children, you would do anything to save them.

@write79 -- I agree that some sort of regulatory system needs to be put in place, something like a stem cell ethics law. I am completely against the idea of killing embryos to get stem cells, but if the stem cells are retrieved from an umbilical cord, I don't see a problem with it.

There are a lot of people who are against stem cell use, and I can understand the concern. But, I think that if there is a system put in place to regulate the use of stem cells, than they could be used for wonderful things.

While I'm not into using stem cells for cloning, I think that using them to heal injured or sick people is wonderful.

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alabama StemCells Therapy StemCells Therapy

Posted: October 24, 2014 at 10:58 pm

Public release date: 26-Jul-2012 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 x2156 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, July 26, 2012 Administering high-doses of interleukin-2 (IL-2) has been the preferred treatment for patients with stage IV metastatic melanoma. An article published in the current issue of Cancer Biotherapy and Radiopharmaceuticals, a peer-reviewed journal from Mary Ann Liebert, Inc. (http://www.liebertpub.com), explores whether or not this regimen is still the most effective. The article is available free online at the Cancer Biotherapy and Radiopharmaceuticals website (http://www.liebertpub.com/cbr).

In the article Should High-Dose Interleukin-2 Still Be the Preferred Treatment for Patients with Metastatic Melanoma? (http://online.liebertpub.com/doi/full/10.1089/cbr.2012.1220) Robert Dillman and colleagues at the Hoag Institute for Research and Education and Hoag Family Cancer Institute, Newport Beach, CA concluded that until long-term survival data for some of the newer drugs are available, patients with stage IV metastatic melanoma who are well enough to be given intensive IL-2 therapy should receive it initially, either alone or in combination with one of the newer therapeutic agents.

This is an important article that puts into perspective the reasons why IL-2 should continue to be the initial therapy in patients with metastatic melanoma, says Editor Donald J. Buchsbaum, PhD, Division of Radiation Biology, Department of Radiation Oncology, University of Alabama at Birmingham.

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About the Journal

Cancer Biotherapy and Radiopharmaceuticals (http://www.liebertpub.com/cbr), published 10 times a year in print and online, is under the editorial leadership of Editors Donald J. Buchsbaum, PhD and Robert K. Oldham, MD, Lower Keys Cancer Center, Key West, FL. Cancer Biotherapy and Radiopharmaceuticals is the only journal with a specific focus on cancer biotherapy, including monoclonal antibodies, cytokine therapy, cancer gene therapy, cell-based therapies, and other forms of immunotherapy. The Journal includes extensive reporting on advancements in radioimmunotherapy and the use of radiopharmaceuticals and radiolabeled peptides for the development of new cancer treatments. Topics include antibody drug conjugates, fusion toxins and immunotoxins, nanoparticle therapy, vascular therapy, and inhibitors of proliferation signaling pathways.

About the Publisher

Mary Ann Liebert, Inc., publishers (http://www.liebertpub.com) is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Journal of Interferon & Cytokine Research, Human Gene Therapy and Human Gene Therapy Methods, and Stem Cells and Development. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industrys most widely read publication worldwide. A complete list of the firms 70 journals, books, and newsmagazines is available at Mary Ann Liebert, Inc. (http://www.liebertpub.com)

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Life Issues Institute – Successes of Adult Stem Cell …

Posted: October 16, 2014 at 9:58 pm

download the pdf version for print

Real-World Successes of Adult Stem Cell Treatments by: Mr. Bradley Richard Hughes Jr.

Summary: Adult stem cell treatments are beginning to show great promise in treating a wide range of illnesses. Yet the debates in the popular media tend to ignore and obscure the medical breakthroughs made by adult stem cell research-success that has conspicuously eluded embryonic stem cell treatments.

With increasing frequency, American citizens and others from around the globe are experiencing newfound freedom from disease, affliction, and infirmity. Individuals' lives are forever changed with the strengthened faith and renewed hope that arise from healed bodies and physical restoration. These seemingly miraculous cures are the result of adult stem cell treatments. Yet the debates in the popular media tend to ignore and obscure the medical breakthroughs made by adult stem cell research--success that has conspicuously eluded embryonic stem cell treatments.[1]

Adult stem cells (or, more accurately, tissue stem cells) are regenerative cells of the human body that possess the characteristic of plasticity--the ability to specialize and develop into other tissues of the body. Beginning in an unspecialized and undeveloped state, they can be coaxed to become heart tissue, neural matter, skin cells, and a host of other tissues. They are found in our own organs and tissues such as fat, bone marrow, umbilical cord blood, placentas, neuronal sources, and olfactory tissue, which resides in the upper nasal cavity.[2] This simple fact has remarkable implications for medicine--diseased or damaged tissue can become healthy and robust through the infusion of such cells. This has consequently commanded the attention of many researchers as well as those suffering from disease.

It is necessary to note that the power of adult stem cells is not nebulously potential, but tangible and real, as it has produced wonderful results in multiple cases. These have been documented in clinical trials, that is, treatments with human patients. With adult stem cells, physicians have successfully treated autoimmune diseases such as lupus, multiple sclerosis, Crohn's disease, and rheumatoid arthritis.[3] Furthermore, adult stem cells have helped to avert corneal degeneration and to restore vision in cases of blindness.[4] They have also restored proper cardiac function to heart attack sufferers[5] and improved movement in spinal cord injury patients.[6]

It is also important to note that all of these successes have come exclusively from adult stem cell research. Embryonic stem cell research, which requires the destruction of early human life to acquire the cells, has not produced any successes in human patients.[7] The breakthroughs demonstrated by adult stem cells are detailed below.

Spinal Cord Injuries

Spinal cord injuries are one of the most severe forms of debilitation known to humanity. Many times they result in different forms of paralysis, including paraplegia and quadriplegia; other times they involve the immediate or imminent death of the patient. Laura Dominguez is an example of the former. Living in San Antonio, Texas, she was a sixteen-year-old girl attending summer school in 2001. On her way back from class, she and her brother encountered an oil spill on the highway that caused their car to careen out of control. The accident left her paralyzed from the neck down with a C6 vertebrae burst fracture. She subsequently entered various hospitals to be emphatically informed that she would never walk again.[8]

After relocating to San Diego, California, Dominguez and her mother checked into a protracted physical therapy program. While there, they consulted with many spinal cord injury specialists and concluded that the most promising option existed in Portugal, where a cutting-edge procedure was being performed.

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A heartbeat away? Hybrid 'patch' could replace transplants

Posted: October 1, 2014 at 5:56 am

17 hours ago

Because heart cells cannot multiply and cardiac muscles contain few stem cells, heart tissue is unable to repair itself after a heart attack. Now Tel Aviv University researchers are literally setting a new gold standard in cardiac tissue engineering.

Dr. Tal Dvir and his graduate student Michal Shevach of TAU's Department of Biotechnology, Department of Materials Science and Engineering, and Center for Nanoscience and Nanotechnology, have been developing sophisticated micro- and nanotechnological toolsranging in size from one millionth to one billionth of a meterto develop functional substitutes for damaged heart tissues. Searching for innovative methods to restore heart function, especially cardiac "patches" that could be transplanted into the body to replace damaged heart tissue, Dr. Dvir literally struck gold. He and his team discovered that gold particles are able to increase the conductivity of biomaterials.

In a study published by Nano Letters, Dr. Dvir's team presented their model for a superior hybrid cardiac patch, which incorporates biomaterial harvested from patients and gold nanoparticles. "Our goal was twofold," said Dr. Dvir. "To engineer tissue that would not trigger an immune response in the patient, and to fabricate a functional patch not beset by signalling or conductivity problems."

A scaffold for heart cells

Cardiac tissue is engineered by allowing cells, taken from the patient or other sources, to grow on a three-dimensional scaffold, similar to the collagen grid that naturally supports the cells in the heart. Over time, the cells come together to form a tissue that generates its own electrical impulses and expands and contracts spontaneously. The tissue can then be surgically implanted as a patch to replace damaged tissue and improve heart function in patients.

According to Dr. Dvir, recent efforts in the scientific world focus on the use of scaffolds from pig hearts to supply the collagen grid, called the extracellular matrix, with the goal of implanting them in human patients. However, due to residual remnants of antigens such as sugar or other molecules, the human patients' immune cells are likely to attack the animal matrix.

In order to address this immunogenic response, Dr. Dvir's group suggested a new approach. Fatty tissue from a patient's own stomach could be easily and quickly harvested, its cells efficiently removed, and the remaining matrix preserved. This scaffold does not provoke an immune response.

Using gold to create a cardiac network

The second dilemma, to establish functional network signals, was complicated by the use of the human extracellular matrix. "Engineered patches do not establish connections immediately," said Dr. Dvir. "Biomaterial harvested for a matrix tends to be insulating and thus disruptive to network signals."

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