Posts Tagged ‘risk’

Two thirds of cancer cases were genetic of bad luck: study

January 2nd, 2015

TWO thirds of adult cancer cases were the result of genetic bad luck rather than unhealthy living, according to groundbreaking new research from the US.

Johns Hopkins University School of Medicine scientist Dr Bert Vogelstein said random mutations in DNA were the most common cause of cancer, with the rest caused by environment or inherited genes.

But he warned the finding should not be taken as a licence to drink or smoke to excess.

“This study shows that you can add to your risk of getting cancers by smoking or other poor lifestyle factors,” Dr Vogelstein said.

“However, many forms of cancer are due largely to the bad luck of acquiring a mutation in a cancer driver gene regardless of lifestyle and heredity factors.”

Researchers compared the number of times organ stem cells divided with the risk of cancer in the tissues.

Those with the most divisions were generally more prone to tumours.

They found 22 of 31 cancer types were caused by random cell mutations – really just genetic misfortune which scientists could not otherwise explain.

The remainder, including smoking-related lung cancer and skin cancer, were related to heredity and environmental factors like exposure to harmful chemicals.

“Cancer-free longevity in people exposed to cancer-causing agents, such as tobacco, is often attributed to their ‘good genes’, but the truth is that most of them simply had good luck,” Dr Vogelstein said.

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Two thirds of cancer cases were genetic of bad luck: study

Cytori Expects New Japan Laws to Boost Adoption of Cytori Cell Therapy

December 5th, 2014

SAN DIEGO–(BUSINESS WIRE)–Cytori Therapeutics, Inc. (NASDAQ: CYTX) today confirmed that two Japanese regenerative medicine laws, which went into effect on November 25, 2014, remove regulatory uncertainties and provide a clear path for the Company to commercialize and market Cytori Cell Therapy and its Celution System under the Companys existing and planned regulatory approvals.

Japans new regenerative medicine laws substantially clarify regulatory ambiguities of pre-existing guidelines and this news represents a significant event for Cytori, said Dr. Marc Hedrick, President & CEO of Cytori. We have a decade of operating experience in Japan and Cytori is nicely positioned to see an impact both on existing commercial efforts and on our longer-term efforts to obtain therapeutic claims and reimbursement for our products.

Under the two new laws, Cytori believes its Celution System and autologous adipose-derived regenerative cells (ADRCs) can be provided by physicians under current Class I device regulations and used under the lowest risk category (Tier 3) for many procedures with only the approval by accredited regenerative medicine committees and local agencies of the Ministry of Health, Labour and Welfare (MHLW). This regulatory framework is expected to streamline the approval and regulatory process and increase clinical use of Cytori Cell Therapy and the Celution System over the former regulations.

Before these new laws were enacted, the regulatory pathway for clinical use of regenerative cell therapy was one-size-fits-all, irrespective of the risk posed by certain cell types and approaches, said Dr. Hedrick. Now, Cytoris point-of-care Celution System can be transparently integrated into clinical use by providers under our Class I device status and the streamlined approval process granted to cell therapies that pose the lowest risk. Our technology is unique in that respect.

Cytoris Celution System Is in Lowest of Three Risk Categories

The Act on the Safety of Regenerative Medicines and an amendment of the 2013 Pharmaceutical Affairs Act (the PMD Act), collectively termed the Regenerative Medicine Laws, replace the Human Stem Cell Guidelines. Under the new laws, the cell types used in cell therapy and regenerative medicine are classified based on risk. Cell therapies using cells derived from embryonic, induced pluripotent, cultured, genetically altered, animal and allogeneic cells are considered higher risk (Tiers 1 and 2) and will undergo an approval pathway with greater and more stringent oversight due to the presumed higher risk to patients. Cytoris Celution System, which uses the patients own cells at the point-of-care, will be considered in the lowest risk category (Tier 3) for most cases, and will be considered in Tier 2 if used as a non-homologous therapy.

Streamlined Regulatory Approval for Certain Medical Devices

In the near future, Cytori intends to pursue disease-specific or therapeutic claims and reimbursement for Cytoris Celution System and the Company would, at that point, sponsor a clinical trial to obtain Class III device-based approval and reimbursement. The new laws include changes to streamline regulation of Class II and some Class III devices, which will now require the approval of certification bodies rather than the PMDA, similar to the European notified body model. To date, certification bodies have only been used for some Class II devices.

Conditional Regulatory Approval and Reimbursement Potential

As a supplementary benefit to Cytori, the Company may also choose to take advantage of the new conditional approval opportunities granted under the new laws. Once clinical safety and an indication of efficacy are shown, sponsors may apply for their cell product to receive conditional approval for up to seven years and may be eligible for reimbursement under Japans national insurance coverage. Under the conditional approval, the sponsor can then generate post-marketing data to demonstrate further efficacy and cost effectiveness.

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Cytori Expects New Japan Laws to Boost Adoption of Cytori Cell Therapy

New method for reducing tumorigenicity in induced pluripotent stem-cell based therapies

July 24th, 2014



Contact: Kathryn Ruehle 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY — The potential for clinical use of induced pluripotent stem cell (iPSC) technology for transplant-based therapeutic strategies has previously been hindered by the risk of dysregulated cell growth, specifically the development of tumors. The ability to use etoposide treatment to halt teratoma formation in iPSCs for the treatment of heart disease, specifically acute myocardial infarction, is demonstrated in an article in Stem Cells and Development, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available on the Stem Cells and Development website.

In the article ‘Inhibition of DNA topoisomerase II selectively reduces the threat of tumorigenicity following induced pluripotent stem cell-based myocardial therapy’ Saranya Wyles, Andre Terzic, Timothy Nelson, and coauthors, Mayo Clinic (Rochester, MN), discovered a strategy that alone or in conjunction with other methods could significantly reduce the risk of a tumorigenic event occurring. Their work demonstrates how pretreatment with genotoxic etoposide significantly lowered the threat of abnormal growths by removing the contaminated pluripotent cells and establishing an adjunctive therapy to further harness the clinical value of iPSC-derived cardiac regeneration.

“For anyone seeking to exploit iPSC technology in a clinical setting, the Mayo Clinic has described a strategy that significantly mitigates the risk of tumor development. Furthermore, the paper provides benchmark strategies for assessing the localization and persistence of cell-based treatments in a preclinical model,” says Editor-in-Chief Graham C. Parker, PhD, The Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI.


About the Journal

Stem Cells and Development is an authoritative peer-reviewed journal published 24 times per year in print and online. The Journal is dedicated to communication and objective analysis of developments in the biology, characteristics, and therapeutic utility of stem cells, especially those of the hematopoietic system. Complete tables of content and a free sample issue may be viewed on the Stem Cells and Development website.

About the Publisher

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New method for reducing tumorigenicity in induced pluripotent stem-cell based therapies

Fat cells removed from heart attack patients could be re-injected into their chest to help repair the organ …

July 5th, 2014

By Ben Spencer

Published: 09:48 EST, 4 July 2014 | Updated: 10:20 EST, 4 July 2014

Fat removed from a heart attack patient during cardiac surgery could be re-injected into their chest to lower the risk of repeat problems, research suggests.

Scientists think that stem cells in fatty tissue could be extracted and inserted directly into the heart, reducing the chance of future attacks.

The stem cells – blank cells capable of acting as a repair kit for the body by replacing worn-out tissue – can improve the functioning of the heart and strengthen crucial arteries and veins, the researchers found.

Usually most of the fat that is found during open heart surgery is removed and then discarded.

Scientists believe fat removed from a heart attack patient during cardiac surgery could be re-injected into their chest to lower the risk of repeat problems. Stock image

But the new study suggests that the fat could be retained and the useful stem cells isolated and injected back into the heart – all while the patient is still on the operating table.

Canadian cardiologist Dr Ganghong Tian, who will present his findings at a European Society of Cardiology conference in Barcelona tomorrow (Sunday), said: During cardiac surgery fat tissue may need to be removed from patients to expose the heart.

We were intrigued to find out whether this mediastinal fat, which would otherwise be discarded, contained stem cells that could be injected back into the heart before closing the chest.

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Fat cells removed from heart attack patients could be re-injected into their chest to help repair the organ …

New Hope for Stem Cells, Regenerative Medicine Emerges From the Lab

December 18th, 2013

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Newswise Today, December 17, JoVE, the Journal of Visualized Experiments, has published a novel technique that could resolve a snag in stem cell research for application in regenerative medicinea strategy for reprograming cells in vivo to act like stem cells that forgoes the risk of causing tumors.

Dr. Kostas Kostarelos, principal investigator of the Nanomedicine Lab at the University of Manchester, said that he and his colleagues have discovered a safe approach to reprogramming somatic cells (which constitute most of the cells in the body) into induced pluripotent stem (iPS) cells. Research in this field has been embraced as an alternative to the controversial use of embryonic stem cells.

We have induced somatic cells within the liver of adult mice to transiently behave as pluripotent stem cells, said Dr. Kostas Kostarelos, the labs principal investigator, This was done by transfer of four specific genes, previously described by the Nobel-prize winning Shinya Yamanaka, without the use of viruses but simply plasmid DNA [a small circular, double-stranded piece of DNA used for manipulating gene expression in a cell].

The technique comes as an alternative to Dr. Shinya Yamanakas reprograming methods, which won him the Nobel prize in 2012. Dr. Yamanakas approach involved reprogramming somatic cells in vitro by introducing four genes through the use of a virus. While promising, the use of this method has been limited. As Dr. Kostareloss article states, One of the central dogmas of this emerging field is that in vivo implantation of [these stem] cells will lead to their uncontrolled differentiation and the formation of a tumor-like mass.

Dr. Kostarelos and his team have determined that their technique does not share the risk of uncontrolled stem cell growth into tumors as seen in in vitro, viral-based methods. [This is the] only experimental technique to report the in vivo reprogramming of adult somatic cells to pluripotency using non-viral, transient, rapid and safe methods, Kostarelos said.

The Nanomedicine Labs approach involves injecting large volumes of plasmid DNA to reprogram cells. However, because plasmid DNA is short-lived in this scenario, the risk of uncontrolled growth is reduced.

The research group chose to publish their technique with JoVE as a means to emphasize the novelty, uniqueness and simplicity of their procedure. Along with their article, a demonstration of their technique has been published as a peer-reviewed video to ensure the proper replication of this technique by other researchers in the field.

*** About JoVE, the Journal of Visualized Experiments: JoVE, the Journal of Visualized Experiments, is the first and only PubMed/MEDLINE-indexed, peer-reviewed journal devoted to publishing scientific research in a video format. Using an international network of videographers, JoVE films and edits videos of researchers performing new experimental techniques at top universities, allowing students and scientists to learn them much more quickly. As of December 2013, JoVE has published video-protocols from an international community of more than 9,300 authors in the fields of biology, medicine, chemistry, and physics.

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New Hope for Stem Cells, Regenerative Medicine Emerges From the Lab

Stem Cells Made From Cloned Embryos, Now What? – Video

May 18th, 2013

Stem Cells Made From Cloned Embryos, Now What?
Researchers say the possibility of cloning tissue can help fight health problems, but others question the risk it brings of cloning humans.

By: NewsyScience

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Stem Cells Made From Cloned Embryos, Now What? – Video

Cells Extracted From Urine – Video

December 13th, 2012

Cells Extracted From Urine
Scientists develop ways to extract cells from urine. Cells from urine can be used instead of embryonic stem cells to produce neurons in the brain. This method may be used in the future to treat neurological disorders like Alzheimer's and Parkinson's disease. Stem-cell biologist Duanqing Pei along with researchers from Guangzhou Institutes of Biomedicine and Health in China has shown that kidney cells from urine can be turned into neural progenitor cells. Embryonic stem cells are unstable and run the risk of turning into noncancerous tumors. The researchers cultured the urine cells with bacterial DNA, which might be a way to lower the risk of tumors. The benefits of using the urine stem cells rather than embryonic or non-embryonic stem cells is that this noninvasive method can collect samples from patients more easily, the danger of the neurons from the urine samples producing tumor cells is lower and the process of making them in a lab is more efficient for neural cells. Scientists have found that stem cells used to treat neurological disorders can be effective when snorted rather than being transplanted through invasive surgery. There are currently no FDA approved stem cell treatments for neurological disorders.From:GeoBeatsNewsViews:1 0ratingsTime:01:11More inNews Politics

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Cells Extracted From Urine – Video

'Fountain of youth' technique rejuvenates aging stem cells

November 28th, 2012

ScienceDaily (Nov. 27, 2012) A new method of growing cardiac tissue is teaching old stem cells new tricks. The discovery, which transforms aged stem cells into cells that function like much younger ones, may one day enable scientists to grow cardiac patches for damaged or diseased hearts from a patient’s own stem cells — no matter what age the patient — while avoiding the threat of rejection.

Stem cell therapies involving donated bone marrow stem cells run the risk of patient rejection in a portion of the population, argues Milica Radisic, Canada Research Chair in Functional Cardiovascular Tissue Engineering at the Institute of Biomaterials and Biomedical Engineering (IBBME) and Associate Professor in the Department of Chemical Engineering and Applied Chemistry at the University of Toronto.

One method of avoiding the risk of rejection has been to use cells derived from a patient’s own body. But until now, clinical trials of this kind of therapy using elderly patients’ own cells have not been a viable option, since aged cells tend not to function as well as cells from young patients.

“If you want to treat these people with their own cells, how do you do this?”

It’s a problem that Radisic and her co-researcher, Dr. Ren-Ke Li, think they might have an answer for: by creating the conditions for a ‘fountain of youth’ reaction within a tissue culture.

Li holds the Canada Research Chair in Cardiac Regeneration and is a Professor in the Division of Cardiovascular Surgery, cross-appointed to IBBME. He is also a Senior Scientist at the Toronto General Research Institute.

Radisic and Li first create a “micro-environment” that allows heart tissue to grow, with stem cells donated from elderly patients at the Toronto General Hospital.

The cell cultures are then infused with a combination of growth factors — common factors that cause blood vessel growth and cell proliferation — positioned in such a way within the porous scaffolding that the cells are able to be stimulated by these factors.

Dr. Li and his team then tracked the molecular changes in the tissue patch cells. “We saw certain aging factors turned off,” states Li, citing the levels of two molecules in particular, p16 and RGN, which effectively turned back the clock in the cells, returning them to robust and healthy states.

“It’s very exciting research,” says Radisic, who was named one of the top innovators under 35 by MIT in 2008 and winner of the 2012 Young Engineers Canada award.

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'Fountain of youth' technique rejuvenates aging stem cells

A look at stem cells and their current use

September 5th, 2012

Dear Dr. Donohue Since starting to clip your articles, I haven’t found any that deal with using adult stem cells for breakthrough treatments, such as repairing heart damage. Could they help if one needs an aortic valve replacement? A.R.

Answer Stem cells are primitive cells that have the potential of spawning mature cells that carry out specific bodily functions, like skin cells, liver cells, lung cells, heart muscle cells, and on and on. Embryonic stem cells have the greatest potential for differentiating into any of the many varieties of cells that make up all body organs, structures and tissues.

Hematopoietic stem cells are recovered from the bone marrow and, to a lesser extent, the circulating blood. They have been and are being used to restore the bone marrow’s capability of generating blood cells.

At the present time, no stem cell therapy has been used in replacing a heart valve.

Dear Dr. Donohue I would like to know the risk of having a stroke when a carotid artery has a blockage. I was told that doctors don’t go by percentage of blockage now. How is the risk determined? K.C.

Answer An obstruction in the carotid artery, the neck artery that supplies the brain with blood, is not the only cause of a stroke. A piece of a blood clot that has broken off of a main clot elsewhere in the body and been swept into a brain artery is another cause of stroke. I mention this to keep it clear that a blocked carotid is but one risk for a stroke.

The doctors I know still use percentage of reduction in the interior of a carotid artery as a criterion of stroke risk. With a 60 percent to 70 percent or greater narrowing of the carotid artery, people benefit from the opening up of the artery, using a variety of procedures. Some experts feel that a 60 percent narrowing requires only blood-thinning medication, such as aspirin. Others feel that surgical removal of the blockage is indicated.

Other factors have to be considered: the patient’s age, the patient’s wishes and the patient’s health problems unrelated to the artery problem..

Dear Dr. Donohue I am an 85-year-old female, and my doctor has suggested a colonoscopy. I find it a degrading test. The doctor didn’t say why I needed it. Should a woman my age have it? K.C.

Answer The American College of Physicians recommends against screening colonoscopies for people 75 and older or for those people with a life expectancy of less than 10 years. Some add that screening can be stopped only if prior colonoscopies have been normal. No one I know recommends screening at 85.

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A look at stem cells and their current use

OMICS Group :: Journal of Stem Cell Research

June 8th, 2012

07-06-2012 07:52 Stem cells differ from other types of cells as they are unspecialized cells that are capable of differentiating into almost any type of specialised cells. Stem cells have the ability to replace the diseased and damaged tissue in the body, without the risk of rejection and any side effects. Therapy performed using stem cells is termed as “Regenerative medicine” and has many potential benefits in treating a wide variety of diseases and injuries. The journal is the major open access forum for translational research in stem cell therapies.

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OMICS Group :: Journal of Stem Cell Research

ImmunoCellular Therapeutics To Present at Targeting Stem Cells Symposium during 19th Annual Molecular Medicine Tri …

February 17th, 2012


ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular” or the “Company”) (OTCBB: IMUC –News), a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that John Yu, MD, Chairman and Chief Scientific Officer of ImmunoCellular Therapeutics, will deliver a presentation at the Cambridge Healthtech Institute’s inaugural Targeting Stem Cells Symposium as a part of the 19th Annual Molecular Medicine Tri-Conference from February 19-23, 2012. Dr. Yu will present during a session highlighting Emerging Cancer Stem Cell Therapeutics, featuring the Company’s discovery and development of cancer stem cell therapy.

The Cambridge Healthtech Institute’s Targeting Cancer Stem Cells Symposium reflects a growing interest in cancer stem cells and their developing importance in the field of oncology, as more pharmaceutical and biotech companies have begun to focus on cancer stem cells as oncological drug targets. The symposium will feature case studies from those working with cancer stem cells, a history of the role of cancer stem cells in treatment resistance, as well as highlights from ongoing novel cancer stem cell therapeutic development programs and platforms.

About ImmunoCellular Therapeutics, Ltd.

IMUC is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The Company recently commenced a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens including those associated with cancer stem cells for glioblastoma treatment. To learn more about IMUC, please visit

Forward-Looking Statements

This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including the risk that any patents issued covering IMUC’s vaccine technology will not provide significant commercial protection for IMUC’s technology or products; the risk that the safety and efficacy results obtained in the Phase I trial for the dendritic cell- based vaccine will not be confirmed in subsequent trials; the risk that the correlation between immunological response and progression-free and overall survival in the Phase I trial for ICT-107 will not be reflected in statistically significant larger patient populations; the risk that IMUC will not be able to secure a partner company for development or commercialization of ICT-107. Additional risks and uncertainties are described in IMUC's most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K. IMUC undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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ImmunoCellular Therapeutics To Present at Targeting Stem Cells Symposium during 19th Annual Molecular Medicine Tri …

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