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'Game changing' Japan stem-cell study questioned

By adminFebruary 19, 2014Stem Cell Medical Center

12 hours ago Riken researcher Haruko Obokata announces that she discovered a simple way to turn animal cells back to a youthful, neutral state, a feat hailed as a "game-changer" in the quest to grow transplant tissue in the lab, January 28, 2014

A Japanese research institute Tuesday said it was probing its own study that promised a 'game changer' way to create stem cells, a feat hailed as revolutionary for the fast-developing field.

The findings, published by Japanese researcher Haruko Obokata and American partners in a January edition of the British journal Nature, outlined a simple and low-tech approach in the quest to grow transplant tissue in the lab.

But the national institute Riken said Tuesday it had started an investigation over "questions" about the methodology and input data of the study, appointing several in-house and outside experts to pore over the revolutionary report. Obokata works for the institute.

At issue are allegations that the researchers used erroneous image data for the high-profile article, local media reported.

"The experts have already started hearings for the researchers involved in the articles," an institute spokesman said Tuesday, but declined to give further details.

But for the moment the institute is standing by the resultsa spokesman insisted the "findings themselves are unassailable."

Stem cells are primitive cells that, as they grow, differentiate into the various specialised cells that make up the different organsthe brain, the heart, kidney and so on.

The goal is to create stem cells in the lab and nudge them to grow into these differentiated cells, thus replenishing organs damaged by disease or accident.

The researchers' groundbreaking findings said that white blood cells in newborn mice were returned to a versatile state by incubating them in a solution with high acidity for 25 minutes, followed by a five minute spin in a centrifuge and a seven-day spell of immersion in a growth culture.

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'Game changing' Japan stem-cell study questioned

Doubts mount on STAP stem cells

By adminFebruary 19, 2014Stem Cell Clinic

(This story is an update of my earlier blog post on the controversy over whether the stress-created STAP cells actually exist).

A stunning stem cell breakthrough announced last month is being examined for errors by the institute where the studys lead researcher works.

The Riken Institute in Japan has launched an investigation into the study, it told news outlets including the journal Nature, which published the study Jan. 29. The probe was launched after other stem cell researchers, who have failed to replicate the findings, are expressing growing doubt.

The study, led by Haruko Obokata of Riken, found that certain white cells from young mice could be easily converted into embryonic-like or pluripotent stem cells by immersing them in acid or subjecting them to other stresses.

Stem cell researcher Paul Knoepfler / California Institute for Regenerative Medicine

The creation of what the researchers called STAP cells appeared to be a great advance from existing methods used to create what are called induced pluripotent stem cells. The IPS methods require adding genes and chemicals and convert just a small percentage of cells treated.

But scientists examining the study said it apparently used inverted and duplicate images. These included one indicating that the cells grew a placenta, a sure sign that stem cells had been produced. Riken declined to say specifically which allegations it was investigating, according to the news reports.

Additionally, scientists including UC Davis stem cell researcher Paul Knoepfler said the finding appeared very unlikely. Pluripotent stem cells tend to form tumors, so producing them in response to stress should have been weeded out by evolution, Knoepfler wrote on his blog, ipscell.com. Hes also running an informal poll.

Weve had nine people put reports of various kinds there, and none of the reports seemed particularly encouraging, Knoepfler said in a Tuesday interview.

"There's a feeling that the duplication of the placenta image, which now one of the authors has confirmed was indeed a duplication, and also some duplication of data in a paper in 2011 by (co-author Charles) Vacanti and Obokata, has made people more concerned about their level of confidence in the finding overall," Knoepfler said.

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Doubts mount on STAP stem cells

Regenerating orthopedic tissues within the human body

By adminFebruary 19, 2014Stem Cell Clinic

By combining a synthetic scaffolding material with gene delivery techniques, researchers at Duke University are getting closer to being able to generate replacement cartilage where it's needed in the body.

Performing tissue repair with stem cells typically requires applying copious amounts of growth factor proteins -- a task that is very expensive and becomes challenging once the developing material is implanted within a body. In a new study, however, Duke researchers found a way around this limitation by genetically altering the stem cells to make the necessary growth factors all on their own.

They incorporated viruses used to deliver gene therapy to the stem cells into a synthetic material that serves as a template for tissue growth. The resulting material is like a computer; the scaffold provides the hardware and the virus provides the software that programs the stem cells to produce the desired tissue.

The study appears online the week of Feb. 17 in the Proceedings of the National Academy of Sciences.

Farshid Guilak, director of orthopaedic research at Duke University Medical Center, has spent years developing biodegradable synthetic scaffolding that mimics the mechanical properties of cartilage. One challenge he and all biomedical researchers face is getting stem cells to form cartilage within and around the scaffolding, especially after it is implanted into a living being.

The traditional approach has been to introduce growth factor proteins, which signal the stem cells to differentiate into cartilage. Once the process is under way, the growing cartilage can be implanted where needed.

"But a major limitation in engineering tissue replacements has been the difficulty in delivering growth factors to the stem cells once they are implanted in the body," said Guilak, who is also a professor in Duke's Department of Biomedical Engineering. "There's a limited amount of growth factor that you can put into the scaffolding, and once it's released, it's all gone. We need a method for long-term delivery of growth factors, and that's where the gene therapy comes in."

For ideas on how to solve this problem, Guilak turned to his colleague Charles Gersbach, an assistant professor of biomedical engineering and an expert in gene therapy. Gersbach proposed introducing new genes into the stem cells so that they produce the necessary growth factors themselves.

But the conventional methods for gene therapy are complex and difficult to translate into a strategy that would be feasible as a commercial product.

This type of gene therapy generally requires gathering stem cells, modifying them with a virus that transfers the new genes, culturing the resulting genetically altered stem cells until they reach a critical mass, applying them to the synthetic cartilage scaffolding and, finally, implanting it into the body.

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Regenerating orthopedic tissues within the human body

Deep TCR sequencing reveals extensive renewal of the T cell repertoire following autologous stem cell transplant in MS

By adminFebruary 19, 2014Uncategorized

A new study describes the complexity of the new T cell repertoire following immune-depleting therapy to treat multiple sclerosis, improving our understanding of immune tolerance and clinical outcomes.

In the Immune Tolerance Network's (ITN) HALT-MS study, 24 patients with relapsing, remitting multiple sclerosis received high-dose immunosuppression followed by a transplant of their own stem cells, called an autologous stem cell transplant, to potentially reprogram the immune system so that it stops attacking the brain and spinal cord. Data published in the Journal of Clinical Investigation quantified and characterized T cell populations following this aggressive regimen to understand how the reconstituting immune system is related to patient outcomes.

ITN investigators used a high-throughput, deep-sequencing technology (Adaptive Biotechnologies, ImmunoSEQTM Platform) to analyze the T cell receptor (TCR) sequences in CD4+ and CD8+ cells to compare the repertoire at baseline pre-transplant, two months post-transplant and 12 months post-transplant.

Using this approach, alongside conventional flow cytometry, the investigators found that CD4+ and CD8+ lymphocytes exhibit different reconstitution patterns following transplantation. The scientists observed that the dominant CD8+ T cell clones present at baseline were expanded at 12 months post-transplant, suggesting these clones were not effectively eradicated during treatment. In contrast, the dominant CD4+ T cell clones present at baseline were undetectable at 12 months, and the reconstituted CD4+ T cell repertoire was predominantly composed of new clones.

The results also suggest the possibility that differences in repertoire diversity early in the reconstitution process might be associated with clinical outcomes. Nineteen patients who responded to treatment had a more diverse repertoire two months following transplant compared to four patients who did not respond. Despite the low number of non-responders, these comparisons approached statistical significance and point to the possibility that complexity in the T cell compartment may be important for establishing immune tolerance.

This is one of the first studies to quantitatively compare the baseline T cell repertoire with the reconstituted repertoire following autologous stem cell transplant, and provides a previously unseen in-depth analysis of how the immune system reconstitutes itself following immune-depleting therapy.

About The Immune Tolerance Network

The Immune Tolerance Network (ITN) is a research consortium sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The ITN develops and conducts clinical and mechanistic studies of immune tolerance therapies designed to prevent disease-causing immune responses, without compromising the natural protective properties of the immune system. Visit http://www.immunetolerance.org for more information.

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The above story is based on materials provided by Immune Tolerance Network. Note: Materials may be edited for content and length.

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Deep TCR sequencing reveals extensive renewal of the T cell repertoire following autologous stem cell transplant in MS

PROPOSED STEM CELL TREATMENT ON TRACK

By adminFebruary 19, 2014Stem Cell Treatment

By Bradley J. Fikes U-T 12:01 a.m.Feb. 19, 2014

A proposed Parkinsons disease treatment from stem cells is on track for an application to be filed with federal regulators around the start of 2015, International Stem Cell Corp. said Tuesday.

The Carlsbad company said the U.S. Food and Drug Administration had met with researchers for guidance on what steps need to be taken before filing an application.

The meeting went about as expected, said Simon Craw, executive vice president. Ongoing animal studies must be completed, along with safety testing. FDA officials discussed details, such as the number of animals to be tested and how the safety studies are to be conducted, Craw said.

International Stem Cells treatment consists of progenitor cells that mature into neural cells, including those making the neurotransmitter dopamine. These neurons are destroyed in the disease, causing progressive paralysis.

The progenitor cells are to be implanted into the brains of Parkinsons patients, where they are expected to make dopamine and protect the remaining dopamine-making neurons. They are derived from unfertilized, or parthenogenetic, human egg cells, made to grow without fertilization.

Interim data from tests in primates are expected in March, with final results later in the year. The Investigational New Drug application, or IND, is expected to be filed a short while thereafter, Craw said. Filing before years end would be a stretch, Craw said; the filing is more likely to take place in early 2015.

Shares of International Stem Cell closed Tuesday after the announcement at 24 cents, up 7 percent for the day.

The company is working with outside scientists, including D. Eugene Redmond Jr., who is leading a pharmacology/toxicology study. Parkinsons expert Mark Stacy at Duke University will lead the clinical trial. Evan Y. Snyder, a stem cell expert at Sanford-Burnham Medical Research Institute, assists as a scientific adviser.

The companys approach is similar to one being studied by scientists at The Scripps Research Institute led by Jeanne Loring. Moreover, both are expected to ask approval to begin trials around the same time.

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PROPOSED STEM CELL TREATMENT ON TRACK

CardioCell begins 2 heart stem cell trials

By adminFebruary 19, 2014Stem Cell Treatment

CardioCell has begun two new clinical trials of its stem cell treatment for recent heart attack patients, the San Diego company said Wednesday.

A Phase 3 trial has started in Kazakhstan and a Phase 2a trial in the United States, said privately held CardioCell. The stem cells are grown under low oxygen conditions, similar to the natural environment of stem cells in the body, said cardiologist Stephen Epstein, a scientific advisor.

Stem cells grown under higher levels of oxygen common in laboratory environments act differently than those grown in low oxygen levels, which may reduce their regenerative abilities, said Epstein, director of translational and vascular biology research at MedStar Heart Institute in Washington, D.C. Moreover, these cells tolerate ischemia, a reduced blood supply that limits the availability of oxygen and nutrients. Since heart attacks are by definition caused by ischemia, that tolerance should help the cells survive long enough to help, Epstein said.

The stem cells appear to help by producing chemicals that stimulate heart regeneration, Epstein said.

The stem cells are of a type called mesenchymal, taken from bone marrow. They were produced by Stemedica, another San Diego stem cell company, which spun off CardioCell.

More information about the U.S. trial, including eligibility criteria, is available at utsandiego.com/cardiocell. More information about CardioCell is available at http://stemcardiocell.com.

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CardioCell begins 2 heart stem cell trials

Intl. Stem Cell readies for Parkinson's study

By adminFebruary 19, 2014Stem Cell Treatment

A proposed Parkinson's disease treatment from stem cells is on track for an application to be filed with federal regulators around the start of 2015, International Stem Cell Corp. said Tuesday.

The Carlsbad-based company said the U.S. Food and Drug Administration had met with researchers for guidance on what steps need to be taken before filing an application. The meeting went about as expected, said Simon Craw, executive vice president. Ongoing animal studies must be completed, along with safety testing. FDA officials discussed details such as the number of animals to be tested and how the safety studies are to be conducted, Craw said.

International Stem Cell's treatment consists of progenitor cells that mature into neural cells, including those making the neurotransmitter dopamine. These neurons are destroyed in the disease, causing progressive paralysis.

The progenitor cells are to be implanted into the brains of Parkinson's patients, where they are expected to make dopamine and protect the remaining dopamine-making neurons. They are derived from unfertilized, or parthenogenetic, human egg cells, made to grow without fertilization.

Human parthenogenetic neural stem cells in the process of differentiating into dopamine-producing neurons. / International Stem Cell Corp.

Interim data from tests in primates are expected in March, and final results later in the year. The Investigational New Drug application, or IND, is expected to be filed a short while thereafter, Craw said. Filing before year's end "would be a stretch," Craw said; the filing is more likely to take place in early 2015.

Shares of International Stem Cell closed Tuesday after the announcement at 24 cents, up 7 percent for the day. The company is working with outside scientists; including D. Eugene Redmond Jr., who is leading a pharmacology/toxicology study. Parkinson's expert Mark Stacy at Duke University will lead the clinical trial. Evan Y. Snyder, a stem cell expert at Sanford-Burnham Medical Research Institute, assists as a scientific advisor.

The company's approach is similar to one being studied by scientists at The Scripps Research Institute led by Jeanne Loring. Moreover, both are expected to ask approval to begin trials around the same time.

Loring's group gets its cells from the patients to be treated, "reprogrammed" back to an embryonic-like state and called induced pluripotent stem cells, then differentiated into the neural progenitor cells. That treatment's main advantage is the use of the patients' own or autologous cells, expected to minimize any possible immune reaction.

The two groups know each other. Craw said International Stem Cell has hired some of Loring's students, and they have collaborated on some research.

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Intl. Stem Cell readies for Parkinson's study

Acid-Bath Stem Cell Study under Investigation

By adminFebruary 19, 2014Stem Cell Treatment

A research institute is launching an inquiry after allegations of irregularities in two blockbuster papers

The controversial work involved a mouse embryo injected with cells made pluripotent through stress. Credit:Haruko Obokata

A leading Japanese research institute has opened an investigation into a groundbreaking stem-cell study after concerns were raised about its credibility.

The RIKEN center in Kobe announced on Friday that it is looking into alleged irregularities in the work of biologist Haruko Obokata, who works at the institution. She shot to fame last month as the lead author on two paperspublished inNature that demonstrated a simple way to reprogram mature mice cells into an embryonic state by simply applying stress, such as exposure to acid or physical pressure on cell membranes. The RIKEN investigation follows allegations on blog sites about the use of duplicated images in Obokatas papers, and numerous failed attempts to replicate her results.

Cells in an embryonic state can turn into the various types of cells that make up the body, and are therefore an ideal source of patient-specific cells. They can be used to study the development of disease or the effectiveness of drugs and could also be transplanted to regenerate failing organs. A consistent and straightforward path to reprogramming mature cells was first demonstrated in 2006, when a study showed that the introduction of four genes could switch the cells into an embryonic form known as induced pluripotent stem (iPS) cells. The introduction of genes, however, introduces uncertainties about the fidelity of the cells, and Obokatas reports that the feat could be done so simply were met with awe, and a degree of scepticism (see 'Acid bath offers easy path to stem cells').

That scepticism deepened last week when blogs such asPubPeer started noting what seem to be problems in the twoNaturepapers and in an earlier paper from 2011, which relates to the potential of stem cells in adult tissues. In the 2011 paper, on which Obokata is first author, a figure showing bars meant to prove the presence of a certain stem-cell marker appears to have been inverted and then used to show the presence of a different stem-cell marker. A part of that same image appears in a different figure indicating yet another stem-cell marker. The paper contains another apparent unrelated duplication.

The corresponding author of that study, Charles Vacanti, an anaesthesiologist at Harvard Medical School in Boston, toldNaturethat he learned only last week of a mix up of some panels. He has already contacted the journal to request a correction. It certainly appears to have been an honest mistake [that] did not affect any of the data, the conclusions or any other component of the paper, says Vacanti.

The problems in the two recentNaturepapers, on both of which Obokata is a corresponding author (Vacanti is a co-author on both, and corresponding author on one), also relate to images. In one paper, one of the sections in a genomic analysis in the first figure appears to be spliced in. In the other paper, images of two placentas meant to be from different experiments look strikingly similar.

Teruhiko Wakayama, a cloning specialist at Yamanashi University in Yamanashi prefecture, is a co-author on both of the papers and took most of the placental images. He admits that the two look similar but says it may be a case of simple confusion. Wakayama, who left RIKEN during the preparation of the manuscript, says he sent more than a hundred images to Obokata and suggests that there was confusion over which to use. He says he is now looking into the problem.

The scepticism has been inflamed by reports of difficulty in reproducing Obakatas latest results. None of ten prominent stem-cell scientists who responded to a questionnaire fromNaturehas had success. A blog soliciting reports from scientists in the fieldreports eight failures. But most of those attempts did not use the same types of cells that Obokata used.

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Acid-Bath Stem Cell Study under Investigation

Human stem cell research: all viewpoints

By adminFebruary 19, 2014Stell Cell Research

Doctors use stem cell therapy to treat lung diseases …

By adminFebruary 18, 2014Stem Cell Doctors

Tampa, Florida --It's the third leading cause of death in the U.S.You've probably even seen ads for treating COPD, but you may not even know what it is.

Chronic Obstructive Pulmonary Disease is a progressive lung disease likely caused by smoking, but air pollution can also be a factor. According to the American Lung Association, women are 37 percent more likely to have it than men and since there's no cure, people will do anything to breathe a little easier.

Doctors atthe Lung Institute in Tampa are using a lung patient's own stem cells to help treat COPD, emphysema and pulmonary fibrosis byrepairing damaged tissue. Like most patients seeking help, 70-year-old Daniel Odulio depends on an oxygen tank. He flew here all the way from The Philippines to improve his life.

The Lung Institute told 10 News the doctorsuse thelatest FDA-approved commercially available equipment for collecting and isolating stem cells using patients' own blood and adipose fat. They say theinnovative stem cell therapy won't be rejected because the doctors use the patients' own cells.In some cases, patients are able to get rid of their oxygen tanks altogether.

10 News

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Doctors use stem cell therapy to treat lung diseases ...