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Iranian scientist's method protects immature cancer boys' fertility

Funding of $67.5M will come from Genome Canada ($40 million), CIHR ($22.5 million) and the Cancer Stem Cell Consortium ($5 million). Projects will be funded for a maximum of four years. To qualify for funding, researchers must obtain matching funding that at is least equal to that provided through the competition, which will bring the total investment in this research area to close to $140 million. Matching funding is typically derived from provincial, academic, private sector or international sources.

Details about the competition are available here.

Press releases, dated January 31, 2012, about the federal government’s support for personalized medicine, are available here and here.

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The Center for Genetics and Society has filed a brief statement with the Institute of Medicine panel examining the performance of the California stem cell agency, expressing the hope that the inquiry will include “a broader range of sources.”

Marcy Darnovsky, associate executive director of the Berkeley group, said that “a meaningful review by (the IOM) committee could make an important contribution to needed changes at the agency.” Darnovsky’s organization has followed the stem cell effort since its inception.

She noted that CIRM is “a public agency spending increasingly scarce public resources” and has raised the possibility of seeking another multibillion dollar bond measure from voters.

The IOM inquiry has finished half of its public process and is yet to hear an independent analysis of the stem cell agency, which is paying $700,000 for the study.

Earlier Darnovsky told the California Stem Cell Report that the Institute of Medicine has not contacted her organization for comments, although she has spoken with the public relations person for the IOM.

Here is the text of Darnovsky’s statement sent to the IOM.

“The Center for Genetics and Society is a public interest organization working to ensure responsible uses and effective societal governance of human genetic and reproductive technologies.  We support embryonic stem cell research, but have been concerned for some years about a number of aspects of the field, and of the California Institute of Regenerative Medicine in particular.

“We have been closely following CIRM since the campaign for Proposition 71 that established it in 2004. We have attended numerous meetings of the agency’s governing board and Standards Working Group, worked with other public interest groups who share our concerns about CIRM, written frequently about CIRM in our publications, and been cited dozens of times in articles about CIRM in key state and national news outlets.

“In 2006, we published The California Stem Cell Program at One Year: A Progress Report, which assessed CIRM’s performance to that date and offered recommendations. See http://www.geneticsandsociety.org/downloads/200601report.pdf

“In 2008, CGS policy analyst Jesse Reynolds gave invited testimony to the Little Hoover Commission’s hearing on CIRM. See http://www.geneticsandsociety.org/article.php?id=4386

“We are encouraged that the Institute of Medicine is undertaking an independent assessment of CIRM, though we hope that you will invite input from a broader range of sources than were represented at the meeting last month in San Francisco. With key questions about the future of CIRM unresolved, and its leadership contemplating a campaign for another bond measure.

“As I wrote in a recent commentary that expressed our disappointment with the roster of speakers at last month’s hearing,

“Ballot measure or no ballot measure, CIRM will continue to disperse the public money it controls – another billion and a half dollars. This is a public agency spending increasingly scarce public resources. It is funding a field of research in which we place great hopes for medical and scientific advances. These factors make it all the more crucial that CIRM follow the basics of good governance and public accountability, and eschew the hyperbole and exaggerated promises that have tainted stem cell research for so long.

“See  http://www.geneticsandsociety.org/article.php?id=6045

“Please let us know if we can be of help. We would be very glad to share our insights and recommendations.”

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Here is the text of questions from the California Stem Cell Report and answers from the Institute of Medicine concerning its plans to secure independent perspectives during the IOM’s examination of the California stem cell agency. So far, the IOM has not heard publicly from any independent sources.

Christine Stencel, a spokeswoman for the IOM, responded for the IOM. She first gave an overall statement. Then she answered the specific queries. We have inserted the questions from the California Stem Cell Report into her text  in order to make the Q&A easier to follow.

The IOM’s general comment:

“The committee and staff are planning their next info gathering sessions. Specifics of these events haven’t all been worked out yet, but one overall point is that the committee believes it is important to hear the full range of perspectives and experiences with CIRM and the committee members are actively pursuing sources of information that will allow them to adequately answer the questions they’ve been tasked to explore. The study is ongoing and there are still a lot of people and resources to tap and information to learn.

“To your specific questions:”

California Stem Cell Report:

“Does the IOM have plans to talk with or seek statements from such groups as the Little Hoover Commission and the Center for Genetics and Society or state Controller John Chiang?”

IOM response:

“Yes. And the committee is reading all the past reviews of CIRM.”

California Stem Cell Report:

“Does the IOM plan to seek comments from grant applicants rejected by CIRM, particularly businesses? If so how many? How would such applicants be selected by the IOM for interviews or comments?”

IOM response:

“Yes, the committee wishes to hear these perspectives and is seeking ways to get them.”

California Stem Cell Report:

“Does the IOM plan to do more than passively post forms for comment from others? Does it plan to email those forms, for example, to all CIRM grant recipients and applicants who were rejected? Does it plan to follow up to be sure an adequate response is generated?”

IOM response:

“The IOM is proactively working to get survey responses and encouraging people to respond.”

California Stem Cell Report:

“What does the IOM mean by ‘industry partners’ on its (online) forms for comment?”

IOM response:

“Industry partners means CIRM investigators representing for-profit companies.”

California Stem Cell Report:

“Does the IOM plan to examine both public and private complaints about conflicts of interest on the part of CIRM grant reviewers? By private, I mean written complaints to CIRM that the agency retains but has not made public.”

IOM response:

“The committee is looking into the grants review process and working to make sure that the members obtain all relevant insights and information. The committee members intend to invite people who can provide a broad range of experiences with and perspectives of CIRM to the upcoming meeting in April.”

The California Stem Cell Report later asked the IOM if it wanted to comment on a quote that we were considering using, which said,

“In the eyes of the IOM, scientists who draw funding from CIRM and other sources are ‘independent.’ They look at these things differently than regular people would.”

The IOM responded,

“As to the quote you sent, as a response we would just reiterate that the committee is methodically going about its task and during the course of the study aims to gather the full range of information, experiences, and insights relevant to CIRM from a full range of sources.”

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The blue-ribbon panel examining the performance of the $3 billion California stem cell agency is midway through its public process and is yet to hear from a single independent witness during its open sessions.

The panel’s report and recommendations are due this fall and are expected to have a major impact on the seven-year-old agency and its future.

So far, the IOM panel has heard only from employees or directors of the agency and persons representing institutions that have received $418 million in CIRM cash.

The panel of scientists and academics was put together by the prestigious Institute of Medicine under a $700,000 contract with the stem cell agency itself. At the 2010 meeting during which agency directors approved the contract, they expressed hope that the IOM panel’s findings would bolster public support for another multibillion dollar bond measure for the agency, which expects to run out of funds for new grants in 2017.

Last week, the California Stem Cell Report asked the IOM about its plans to gather independent or critical information about the stem cell agency’s performance. With only one more California public meeting scheduled, the IOM said that it is seeking the “full range of perspectives” but did not respond directly to questions about the specifics of how it is going to fulfill that task.

None of the four organizations in California that have an independent perspective on CIRM have been contacted by the IOM, the California Stem Cell Report has been told. They are the state’s Little Hoover Commission, the Center for Genetics and Society, Consumer Watchdog and the Citizens Financial Accountability and Oversight Committee, which is the only state body specifically charged with oversight of CIRM and its directors and which is chaired by the state’s top fiscal officer, Controller John Chiang. A spokeswoman for the IOM panel said, however, it plans to touch base with at least some of the four.

In response to questions from the California Stem Cell Report, Christine Stencel, the IOM spokeswoman, said the IOM also wants to hear comments from businesses whose applications have been rejected by CIRM. However, she said the panel is still working on “ways to get them.” She did not respond directly to questions about how many of such businesses would be interviewed or how they would be selected. The tiny number of CIRM grants to business is a sore spot with industry. Even directors and CIRM’s own “external review” panel have said much more is needed.

In response to a question about complaints about conflicts of interest on the part of CIRM reviewers, Stencel was also non-specific, saying only that the panel wants to “obtain all relevant insights.” She did not respond directly to a question about whether the panel would examine “private complaints” filed with CIRM by rejected applicants.

Currently the IOM has forms posted online that interested parties, if they know about the existence of the forms, can use to comment on CIRM. We asked whether the panel plans to do more than passively post the forms, specifically whether it plans to email them to all CIRM applicants who were rejected. We also asked about IOM plans to follow up to generate an adequate response. Stencel said the IOM is “proactively working” to get survey responses but did not say what specific steps it was taking.

Our comment?

The IOM has a well-deserved reputation for rigor and thoroughness. However, the IOM is all but unknown to 99 pecent of the public, which will be the ultimate consumer of its findings on the stem cell agency. The fact that the IOM is being paid $700,000 by CIRM will undoubtedly raise questions in the minds of some about IOM’s own objectivity. The panel itself consists of persons who have like-minded interests and sympathy with CIRM and its 485 grant recipients. No member of the panel is likely to publicly discourage more scientific research, even if CIRM is deemed to be failing to fulfill the voters expectations in 2004 when they created the agency. All the more reason to aggressively seek out those with contrary views about CIRM’s performances, if the IOM’s report is to have maximum credibility.

Earlier this week we heard from a knowledgeable and longtime observer of the research scene, who said that the IOM looks at things “differently than regular people” and views scientists who receive funding from CIRM as “independent.” The IOM’s Stencel responded by reiterating that the IOM is seeking the full range of information from the full range of sources.

The IOM evaluation of CIRM’s performance is much too far along not to have progressed further with its attempts to hear from independent and critical voices about CIRM. Generalizations to the effect that “we are going to get to it” do not serve the panel well. The IOM should lay out publicly and quite specifically its plans to aggressively seek thoughtful analysis from parties that do not have financial or professional links to CIRM, as well as from those who feel they have received a short shrift from the $3 billion enterprise.

You can read the full text of the questions from the California Stem Cell Report and the IOM responses here.

Source:
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The prestigious journal Nature today said that asking California voters for more billions for stem cell research in a few years “may strike residents as a luxury that they can ill afford.”

The comment came in a piece by Erika Check Hayden dealing with the future of the California stem cell agency, which is expected to run out of money for new grants in about 2017. She wrote,

“Given that California is facing severe budget shortfalls, several billion dollars more for stem-cell science may strike residents as a luxury that they can ill afford. It may also prove difficult for CIRM’s supporters to point to any treatments that have emerged from the state’s investment. So far, the agency has funded only one clinical trial using embryonic stem cells, and that was halted by its sponsor, Geron of Menlo Park, California, last November.

“Yet the institute has spent just over $1 billion on new buildings and labs, basic research, training and translational research, often for projects that scientists say are crucial and would be difficult to get funded any other way. So the prospect of a future without CIRM is provoking unease. ‘It would be a very different landscape if CIRM were not around,’ says Howard Chang, a dermatologist and genome scientist at Stanford University in California.”

Chang was a scheduled witness recently at a public meeting in California of the blue-ribbon Institute of Medicine panel examining the performance of the Golden State’s $3 billion stem cell research effort. Chang is the recipient of $3.2 million in CIRM funding. Hayden wrote,

“Chang has a CIRM grant to examine epigenetics in human embryonic stem cells, and is part of another CIRM-funded team that is preparing a developmental regulatory protein for use as a regenerative therapy. Both projects would be difficult to continue without the agency, he says. Federal funding for research using human embryonic stem cells remains controversial, and could dry up altogether after the next presidential election (see Nature 481, 421–423; 2012). And neither of Chang’s other funders — the US National Institutes of Health (NIH) and the Howard Hughes Medical Institute in Chevy Chase, Maryland — supports his interdisciplinary translational work. Irina Conboy, a stem-cell engineer at the University of California, Berkeley, who draws half of her lab’s funding from CIRM, agrees that in supporting work that has specific clinical goals, the agency occupies a niche that will not easily be filled by basic-research funders. ‘The NIH might say that the work does not have a strong theoretical component, so you’re not learning anything new,’ she says.”

Conboy was also a scheduled witness at the IOM hearing. She holds $2.2 million in CIRM grants.

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Hepatitis C is a viral disease that leads to inflammation and organ failure. However, researchers are puzzled as to why some individuals are very susceptible to the disease, while others are not.

Researchers believe they could find out how genetic variations produce these different responses by investigating liver cells from different individuals in the lab. However, liver cells are hard to obtain and extremely challenging to grow in a lab dish as they often lose their normal function and structure when removed from the body.

Now, scientists from MIT, Rockefeller University and the Medical College of Wisconsin have found a technique to generate liver-like cells from induced pluripotent stem cells (iPSCs). iPSCs are created from body tissues instead of embryos; the liver-like cells that can be infected with hepatitis C. iPSCs could allow researchers to investigate why individuals respond differently to the disease. The study is published in the Proceedings of the National Academy of Sciences.

Although many research terms have tried to established an infection in cells obtained from iPSCs, this study is the first to have done so. In addition, the new technique could eventually facilitate “personalized medicine.” Using tissues obtained from the patient being treated, doctors could test the effectiveness of various medications and customize a treatment for that individual patient.

This study is a joint effort between Sangeeta Bhatia, the John and Dorothy Wilson Professor of Health Sciences and Technology and Electrical Engineering and Computer Science at MIT; Charles Rice, a professor of virology at Rockefeller; and Stephen Duncan, a professor of human and molecular genetics at the Medical College of Wisconsin.

In 2011, Bhatia and Rice revealed that by growing liver cells on special micropatterned plates that direct their organization, they could influence the cells to grow outside the body. Although, these cells can be infected with hepatitis C, researchers cannot proactively research the role of genetic variation in viral responses, as the cells derive from organs donated for transplantation and represent only a small population.

Bhatia and Rice collaborated with Duncan, who had demonstrated that he could transform iPSCs into liver-like cells, in order to produce cells with more genetic variation.

Often, such iPSCs are taken from skin cells. Researchers can restore these cells to an immature state – the same as embryonic stem cells – which can differentiate into any cell type by switching on specific genes in those cells. The cells can then be directed, once they become pluripotent, to become liver-like cells by switching on genes that regulate liver development.

In this study, MIT postdoc Robert Schwartz and graduate student Kartik Trehan infected those liver-like cells with hepatitis C. They created the viruses to expel a light-producing protein each time they went through their life cycle in order to confirm that infection had taken place.

The primary goal for the team is to obtain cells from individuals who had unusual reactions to hepatitis C infection and transform them into liver cells in order to research their genetics to find out why they responded the way they did.

Bhatia explains:

“Hepatitis C virus causes an unusually robust infection in some people, while others are very good at clearing it. It's not yet known why those differences exist.”

One possible reason may be genetic variations in the expression of immune molecules, such as interleukin-28, a protein that has been demonstrated to play a vital role in the response to hepatitis infection. Other potential factors include, cell's susceptibility to having viruses control their replication machinery and other cellular structures, as well as cell's expression of surface proteins that allow the virus to penetrate the cells.

Bhatia explains the liver-like cells generated in this investigation are similar to “late fetal” liver cells. The team is currently working on producing more mature liver cells.

The long-term goal for the team is personalized treatments for individuals with hepatitis. According to Bhatia one could imagine obtaining cells from an individual, making iPSCs, reprogramming them into liver cells and infecting them with the same strain of hepatitis that the individual has. This would allow doctors to test various medications on the cells to find out which ones are better at clearing the infection.

Written by Grace Rattue
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Feb. 3, 2012

Using lab-grown human neurons, researchers from the University of Wisconsin-Madison have devised an effective assay for detecting botulinum neurotoxin, the agent widely used to cosmetically smooth the wrinkles of age and, increasingly, for an array of medical disorders ranging from muscle spasticity to loss of bladder control.

The new assay uses neurons, the critical impulse conducting cells of the central nervous system, derived from induced human pluripotent stem cells. It is the first test to employ stem cell derivatives to reliably and quantitatively detect botulinum neurotoxin and the antibodies that can neutralize the toxin's effects.

The assay is likely to draw considerable interest from industry as a potential replacement for the mouse, an animal now used by the thousands to control the potency of pharmaceutical preparations of the powerful neurotoxin.

Using cells provided by Madison-based Cellular Dynamics International, a company that industrially manufactures induced pluripotent stem cells and their derivative tissue cells for use in research and industry, the University of Wisconsin-Madison team devised an assay that is more sensitive than the mouse assay required for quality control of pharmaceutical preparations of botulinum toxin.

“This is an optimal testing platform for botulinum neurotoxin products,” explains Sabine Pellett who, with UW-Madison professor of bacteriology Eric A. Johnson, led the new study published this week in the journal Toxicological Sciences. “A cell-based assay that is at least as sensitive and reproducible as the mouse bioassay can serve as a viable alternative and largely eliminate the need to use animals.”

The toxin is used most famously for cosmetic purposes to erase the facial wrinkles that come with age. However, it is also used in a growing number of medical applications. Since it was first approved in 1990 for use in human patients with strabismus or cross-eye, the toxin, which works by blocking communication between nerves and muscles, has been used to successfully treat excessive sweating, chronic migraine headaches, painful neck spasms known as dystonia, and muscle conditions associated with cerebral palsy, multiple sclerosis and stroke. In 2010, the Food and Drug Administration (FDA) approved the toxin for use in treating loss of bladder control. Pharmaceutical applications of the toxin underpin a market that easily exceeds $1 billion annually.

Botulinum toxin is a protein produced by the bacterium Clostridium botulinum. It is the most potent toxin known to science and before its first experimental medical application to treat cross-eye was best known as a food poison. The methods to produce the toxin in large quantities and to precise specifications were pioneered at UW-Madison by Johnson and his late mentor, Ed Schantz.

Because of its incredible potency, the quality and dosages of the toxin for medical use must be carefully prepared.

The preparations made by pharmaceutical companies, says Johnson, actually contain very little toxin. To ensure that batches of the agent are of the correct therapeutic dose and of uniform quality, they are tested by injecting mice at a specified dosage that kills half of all mice exposed to the toxin.

“The mouse assay has many drawbacks and hundreds of thousands of mice are used for this every year,” Pellett explains. “The most important result of this study is the high sensitivity of the assay, greater than the mouse bioassay, which is required for quality control.”

The pharmaceutical industry, Johnson adds, is under pressure from the FDA to develop alternatives to the mouse. One cell-based assay has already been developed by Allergan, the company that makes BOTOX, the most famous trade name for botulinum toxin. However, the details of that assay have not been made available.

“The assay we developed is another cell based assay,” notes Pellett, “one that uses normal human neurons derived from induced pluripotent stem cells, and which can be optimized for any pharmaceutical botulinum neurotoxin product.”

In addition to Pellett and Johnson, authors of the new study include Regina Whitemarsh and William H. Tepp, of UW-Madison; and Monica. J. Strathman, Lucas G. Chase and Casey Stankewicz of Cellular Dynamics International. The study was funded by the U.S. National Institutes of Health.

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Neurons from stem cells could replace mice in botulinum test

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The Hindu Shinya Yamanaka, Centre for iPS Cell Research and Application, Japan delivering a lecture in Chennai on Thursday. Photo: V. Ganesan

Many more diseases can be targeted, says expert

While applications of induced pluripotent stem cells in stem cell therapy may be limited to a few diseases, its applications in drug discovery are wide-ranging, and many more diseases can be targeted, Shinya Yamanaka, Director, Centre for iPS Cell Research and Application, Japan, has said.

The Japanese scientist, whose breakthrough was the creation of embryonic-like stem cells from adult skin cells, believes that the best chance for stem cell therapy lies in offering hope to those suffering from a few conditions, among them, macular disease, Type 1 Diabetes, and spinal cord injuries.

On the other hand, there were multiple possibilities with drug discovery for a range of diseases, and Prof. Yamanaka was hopeful that more scientists would continue to use iPS for studying this potential.

He currently serves as the Director of the Center for iPS Cell Research and Application and as Professor at the Institute for Frontier Medical Sciences at Kyoto University. He is also a Senior Investigator at the University of California, San Francisco (UCSF) – affiliated J. David Gladstone Institutes.

An invited speaker of the CellPress-TNQ India Distinguished Lectureship Series, co-sponsored by Cell Press and TNQ Books and Journals, Prof. Yamanaka spoke to a Chennai audience on Tuesday evening about those “immortal” cells, that he originally thought would take “forever” to create, but actually took only six years.

“My fixed vision for my research team was to re-programme adult cells to function like embryonic-like stem cells. I knew it could be done, but just didn't know how to do it,” Prof. Yamanaka said.

Embryonic stem cells are important because they are pluripotent, or possess the ability to differentiate into any other type of cell, and are capable of rapid proliferation. However, despite the immense possibilities of that, embryonic cells are a mixed blessing: there are issues with post-transplant rejection (since they cannot be used from a patient's own cells), and many countries of the world do not allow the use of human embryos.

Dr. Yamanaka's solution would scale these challenges if only he and his team could find a way to endow non-embryonic cells with those two key characteristics of embryonic stem cells.

In 2006, he and his team of young researchers — Yoshimi Tokuzawa, Kazutoshi Takahashi and Tomoko Ishisaka — were able to show that by introducing four factors into mouse skin cells, it was possible to generate ES-like mouse cells. The next year, they followed up that achievement, replicating the same strategy and converted human skin cells into iPS cells. “All we need is a small sample of skin (2-3millimetres) from the patient. This will be used to generate skin fibroblasts, and adding the factors, they can be converted to iPS cells. These cells can make any type of cell, including beating cardiac myocytes (heart cells), Prof.Yamanaka explained.

iPS cells hold out for humanity a lot of hope in curing diseases that have a single cell cause. Prominent among them are Lou Gehrig's Disease or Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease. Motor neurons degenerate and die, and no effective treatment exists thus far. One reason is that there have not been good disease models for ALS in humans. It is difficult to get motor neuron from human patients and motor neurons cannot divide.

“Now, iPS cells can proliferate and can be differentiated to make motor neurons in large numbers,” he explained. Already a scientist in Japan has clarified motor neuron cells from iPS. “We are hoping that in the near future we would be able to evolve drug candidates that will be useful for ALS patients.” Treatment of spinal cord injuries using iPS cells has showed good results in mice and monkey specimens, and it is likely that in two or three years, scientists will be ready to start treatment for humans.

Toxicology, or drug side effects, is another area where iPS cells can be of use. Testing drug candidates directly on patients can be extremely dangerous. However, iPS cells can be differentiated into the requisite cell type, and the drugs tested on them for reactions. And yet, as wonderful as they may seem, iPS cells do have drawbacks, and there are multiple challenges to be faced before the technology can be applied to medicine. Are they equivalent and indistinguishable from ES cells? For a technology that has been around for only five years, the questions remain about safety. Also to derive patient-specific iPS cells, the process is time, and money-consuming, Prof. Yamanaka pointed out.

There are however, solutions in the offing, for the man who made the world's jaw drop with his discovery. One would be to create an iPS cell bank, where iPS cells could be created in advance from healthy volunteers donating peripheral blood, and skin fibroblasts, apart from frozen cord blood. The process of setting a rigorous quality control mechanism to select the best and safest iPS clones is on and would be complete within a year or two. “Many scientists are studying iPS cells across the world, and I'm optimistic that because of these efforts, we can overcome the challenges of iPS, and contribute to newer treatments for intractable diseases,” Prof. Yamanaka said.

N. Ram, Director, Kasturi & Sons Limited, introduced the speaker. Mariam Ram, managing director, TNQ India; and Emilie Marcus, executive editor, Cell Press, spoke.

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“Wide-ranging applications for pluripotent stem cells”