StemCell Therapy

A blue-ribbon Institute of Medicine panel is broadening its reach in its examination of the performance of the $3 billion California stem cell agency.

The group will hold a one-day public hearing next Tuesday at UC Irvine that will include independent perspectives along with comments from biotech firms, some of which have been unhappy with the paucity of CIRM funding for industry. The IOM has additionally expanded its efforts to generate responses to its questionnaires to include rejected applicants and the general public.

The hearing is the last public session scheduled in California and will be audiocast on the Internet. The IOM's fourth and final public session is scheduled for some time later this year with release of the full report in November. The stem cell agency is paying the IOM $700,000 to conduct the study. The public sessions so far have been taken up with testimony from recipients of CIRM largesse or from employees or directors of the agency.

The list of independent witnesses next week includes Stuart Drown, executive director of the state's good government agency, the Little Hoover Commission, which conducted a lengthy study of the stem cell agency. Also on tap are others including:

• Ruth Holton-Hodson, California deputy state controller, and who deals with CIRM issues for the state controller, who chairs the only state body officially charged with overseeing the agency.
• Marcy Darnovsky, associate executive director of the Center for Genetics and Society in Berkeley, an organization that has been critical of CIRM
• David Jensen, publisher of the California Stem Cell Report, which has posted more than 3,000 items on the agency since 2004 in addition to a number of freelance articles. 

The IOM has widened its efforts to secure comments from persons who cannot appear at its hearings. At the IOM's request, CIRM sent emails about the questionnaires to the 4,039 persons who have asked the agency to be notified about its RFAs. Recipients were asked by CIRM to complete the IOM surveys.

The online forms are due by April 23. Here are links in the various categories:  general public, CIRM investigators,CIRM industry partners, leadership from CIRM-funded institutions, technology transfer professionals,CIRM's international collaborators, members of the Independent Citizens' Oversight Committee (the CIRM governing board), and investigators not funded by CIRM.

The IOM said access to the Internet audiocast of the meeting can be gained on April 10 through this web page.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Chuck Winner is a name that doesn't surface often in connection with California's $3 billion stem cell research effort.

Chuck Winner (left) at USC in 2006 USC Photo

In fact, he rarely appears in the news. Winner's name, however, did surface yesterday when Gov. Jerry Brown appointed him to the state's horse racing board. Most of the stories about the appointment were in horse racing publications. But none, including The Sacramento Bee's, mentioned the Prop. 71 campaign managed by his firm, Winner & Mandabach Campaigns of Santa Monica, Ca.

Nonetheless, he and his firm were the key to winning approval of the 2004 ballot measure that created the California Institute of Regenerative Medicine, an enterprise that is unprecedented in state or national history.

The firm's $35 million campaign for Prop. 71 attracted 59 percent of the vote. That same year, the firm also successfully managed four other ballot measures in the Golden State. Its lifetime average is remarkable. The firm's web site says it has won 90 percent of the 150 ballot measure campaigns it has run throughout the country.

Winner-Mandabach has this to say about how it pulled off the Prop. 71 campaign:

"Surveys (in 2003-04) showed that most voters supported the basic concept of expanding stem cell research. However, because of the state’s serious budget and debt problems, it was also clear that passing such a huge bond measure for any purpose would be a major challenge.

"The campaign overseen by Winner & Mandabach to overcome those odds involved a year-long coalition building effort that ultimately recruited over 40 Nobel Prize winning scientists and more than 100 patient groups, disease foundations and business groups – the largest, most diverse coalition of its kind ever formed to support a state ballot measure. The supporting groups helped mount an intense grassroots outreach and activation effort to their members, who numbered in the millions."

Winner-Mandabach continued,

"The TV advertising developed by the firm featured award-winning scientists, patients and their families, and highly-respected patient advocates like Michael J. Fox and the late Christopher Reeve. The ads focused on the potential for cures that could save millions of lives. Details of the initiative and economic issues were addressed through in-depth mail pieces and earned media efforts that included the release of an economic study showing that stem cell cures would help reduce the state’s skyrocketing health care costs. Prior to the implementation of the paid media campaign in late-September, polling showed Proposition 71 below the 50% threshold. But after an intense 6-week advertising, earned media and grassroots campaign, Prop. 71 steadily gained support, even in the face of final attacks by conservative groups and activists like Mel Gibson, and attacks from the left by some anti-biotech groups. Because of its precedent-setting nature, the Prop. 71 campaign became the most watched ballot measure campaign in the nation and generated worldwide press attention. On election day, it was approved overwhelmingly by a vote of 59% to 41%."

The key to success on any ballot measure is a firm like Winner-Mandabach, although high profile individuals – in the case of Prop. 71, Robert Klein, who became the first chairman of the stem cell agency – are often given complete credit. Top notch campaign firms have a keen understanding of voters, appropriate political timing and effective PR and TV advertising campaigns. Without Winner-Mandabach – or a firm with the same skillset – the California stem cell agency would not exist.

Chuck Winner, however, does not have an uncritical view of the ballot initiative process, which has resulted in much expensive mischief in California. He told a USC audience in 2006,

"It’s abused time and again. My opinion is that when you circumvent the legislative process or representative democracy to solve a problem, you can take it to an extreme and that extreme becomes, in some ways, worse than the problem you were trying to solve in the first place. Single-issue up or down initiative votes are very often not the best way to govern."

As for the horse racing business, Winner, a Beverly Hills resident, has been involved in horse racing since 1986. His partner, Paul Mandabach, is also involved in the sport of kings. Their firm has not disclosed their record at the track.

(Click here to see two powerful ads developed for the 2004 campaign, including the famous Christopher Reeve spot.)

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

SAN FRANCISCO – A proposed $17.9 million operational budget for the California stem cell agency has cleared a key hurdle despite objections concerning the addition of another attorney to its $2.4 million annual legal effort.

The spending plan was approved yesterday by the CIRM directors' Finance Subcommittee on an 8-0 vote. The proposal is 7.2 percent higher than spending for the current fiscal year, which ends in June. The agency by law operates with a stringent budget cap of 6 percent of its bond funding.

Most of the budget goes for salaries at the agency, which has slightly more than 50 employees. The agency spends $8.4 million annually administering its 400-plus grants and developing new grant programs.

The proposal to add another lawyer to its staff drew fire from CIRM Co-vice chairman Art Torres. He asked why the agency wanted to spend more money for "a lawyer we don't need."

CIRM President Alan Trounson and CIRM General Counsel Elona Baum defended the plan, saying another lawyer was needed to deal with intellectual property and research commercialization issues. They said that grantee institutions and businesses are not dealing with the legal ramifications in a satisfactory manner.

Trounson said the agency would be "at risk" if it did not have control of the legal issues.

Torres brought up a memo on the subject, which he said did not justify the addition of a lawyer. Other directors said they had not seen the memo and asked for copies. The California Stem Cell Report has also asked for a copy.

Michael Goldberg, a venture capitalist and chair of the Finance Subcommittee, asked CIRM staff and a handful of directors to resolve the matter between now and the end of May, when the budget is expected to be approved by the full board.

Currently CIRM has five attorneys on staff, not including directors who are lawyers. The budget for the internal legal operation is $1.3 million annually. The rest of the $2.4 million goes for contracted services, including the firm of Remcho, Johansen & Purcell of San Leandro, Ca., a highly regarded political and governmentally oriented law firm that is budgeted for as much as $650,000 for the coming year, down from $695,000 this year. Another attorney is also on contract for $250,000, down from $325,000 this year.

CIRM budget documents projected savings in $190,000 in legal costs from the current year that could be used to help hire another attorney. The total legal costs for next year are budgeted at $2.44 million, compared to $2.39 million for the current year.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

SAN FRANCISCO -- The California stem cell agency scored during the weekend in a front page story in the San Francisco Chronicle that heralded a possible cancer treatment involving a "don't-eat-me-molecule."

The piece by Victoria Colliver said,

"In a potential breakthrough for cancer research, Stanford immunologists discovered they can shrink or even get rid of a wide range of human cancers by treating them with a single antibody."

The story was played prominently on the Chronicle front page on Saturday. However, the stem cell agency and its funding role was not mentioned until the last paragraph of the story. Nonetheless, on Saturday night, the Chronicle website reported that it was the most read and most emailed story on its site at that time.

When we looked at the story that evening, the article had 84 comments from readers, including several which praised the agency for its work. One reader noted, however, that other funding agencies were involved besides the California stem cell agency. The reader quoted from the Stanford press release, which said,

"This work was supported by the Joseph & Laurie Lacob Gynecologic/Ovarian Cancer Fund, the Jim & Carolyn Pride Fund, the Virginia & D.K. Ludwig Fund for Cancer Research, the Weston Havens Foundation, the National Cancer Institute, the Department of Defense, the California Institute for Regenerative Medicine and anonymous donors."

Stanford's news release said,

"It is the first antibody treatment shown to be broadly effective against a variety of human solid tumors, and the dramatic response — including some overt cures in the laboratory animals — has the investigators eager to begin phase-1 and –2 human clinical trials within the next two years."

The Los Angeles Times also carried a story last week on the research, but did not mention CIRM. The agency itself wrote about the research on its blog.

CIRM Chairman J.T. Thomas and other CIRM directors have been concerned about the lack of coverage in the mainstream media – particularly favorable coverage – of the agency's work. When this writer was at a meeting yesterday afternoon at CIRM headquarters in San Francisco, Thomas pointedly presented a copy of the Chronicle front page, suggesting the article was worthy of note. Thomas is correct; the piece can certainly be counted as a favorable mention of the $3 billion research effort. Now it is up to CIRM and its new communications director, Kevin McCormack, who began work on Monday, to multiply the Chronicle piece many times over.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Source:
http://feeds.feedburner.com/integratedmedicine

A little more than three years ago a medical team from Berlin published the results of a unique experiment that astonished HIV researchers. The German group had taken bone marrow--the source of the body’s immune cells--from an anonymous donor whose genetic inheritance made him or her naturally resistant to HIV. Then the researchers transplanted the cells into a man with leukemia who had been HIV-positive for more than 10 years. Although treatment of the patient’s leukemia was the rationale for the bone marrow transplant therapy, the group also hoped that the transplant would provide enough HIV-resistant cells to control the man’s infection. The therapy exceeded the team’s expectations. Instead of just decreasing the amount of HIV in the patient’s blood, the transplant wiped out all detectable traces of the virus from his body, including in multiple tissues where it could have lain dormant. The German researchers were so surprised by the spectacularly positive results that they waited nearly two years before publishing their data.

[More]

Source:
http://rss.sciam.com/sciam/topic/gene-therapy

Antidepressants restore well-being to many people, but sometimes at the cost of such side effects as weight gain or loss of interest in sex. And these side effects can be just part of the frustration. As Robin Marantz Henig wrote in " Lifting the Black Cloud ," in the March issue of Scientific American , the drugs that have long dominated the market--the selective serotonin reuptake inhibitors (SSRIs) and the serotonin and norepinephrine reuptake inhibitors (SNRIs)--"do not help everyone and eventually fail in more than a third of users. A pill that seems to be working today might well stop helping tomorrow. And the drugs can take several weeks to start having a marked effect." Equally disturbing, some major pharmaceutical houses, such as GlaxoSmithKline , are pulling back from developing psychiatric medicines.

[More]

Source:
http://rss.sciam.com/sciam/topic/gene-therapy

A young woman who calls herself blue­berryoctopus had been taking anti­depressants for three years, mostly for anxiety and panic attacks, when she recounted her struggles with them on the Web site Experience Project. She said she had spent a year on Paxil, one of the popular SSRIs (selective serotonin reuptake inhibitors), but finally stopped because it destroyed her sex drive. She switched to Xanax, an ­antianxiety drug , which brought back her libido but at the cost of renewed symptoms. Then Paxil again, then Lexapro (another SSRI), then Pristiq, a member of a related class of antidepressants, the SNRIs (serotonin and norepinephrine reuptake inhibitors). At the time of the post, she was on yet another SSRI, Zoloft, plus Wellbutrin (a cousin of SNRIs that affects the activity of dopamine as well as norepinephrine), which was intended to counteract the sexual side effects of Zoloft. “I don’t notice much of a difference with the Wellbutrin, but I’m on the lowest dose now,” she wrote. “I’m going back to my psychiatrist next week, so maybe he’ll up it. Who knows.”

[More]

Source:
http://rss.sciam.com/sciam/topic/gene-therapy

Via Scoop.it – inPharmatics

 Quintiles and the American Diabetes Association announced a strategic agreement in which Quintiles’ Digital Patient Unit will provide the Association’s millions of website users access to Quintiles’ medication monitoring service.

The Association’s constituents who opt in for the service will receive free safety checks of their medications to identify potential interactions and other risk factors, which are already provided to the 2.5 million registered users of Quintiles’ http://www.MediGuard.org. Registrants will also be eligible to participate in select direct-to-patient programs to benefit their medical conditions and advance global diabetes patient care.

The Association’s constituents may opt in to this service from the Association’s website http://www.Diabetes.org

Via http://www.quintiles.com

Source:
http://microarray.wordpress.com/feed/

A blue-ribbon Institute of Medicine panel is broadening its reach in its examination of the performance of the $3 billion California stem cell agency.

The group will hold a one-day public hearing next Tuesday at UC Irvine that will include independent perspectives along with comments from biotech firms, some of which have been unhappy with the paucity of CIRM funding for industry. The IOM has additionally expanded its efforts to generate responses to its questionnaires to include rejected applicants and the general public.

The hearing is the last public session scheduled in California and will be audiocast on the Internet. The IOM's fourth and final public session is scheduled for some time later this year with release of the full report in November. The stem cell agency is paying the IOM $700,000 to conduct the study. The public sessions so far have been taken up with testimony from recipients of CIRM largesse or from employees or directors of the agency.

The list of independent witnesses next week includes Stuart Drown, executive director of the state's good government agency, the Little Hoover Commission, which conducted a lengthy study of the stem cell agency. Also on tap are others including:

• Ruth Holton-Hodson, California deputy state controller, and who deals with CIRM issues for the state controller, who chairs the only state body officially charged with overseeing the agency.
• Marcy Darnovsky, associate executive director of the Center for Genetics and Society in Berkeley, an organization that has been critical of CIRM
• David Jensen, publisher of the California Stem Cell Report, which has posted more than 3,000 items on the agency since 2004 in addition to a number of freelance articles. 

The IOM has widened its efforts to secure comments from persons who cannot appear at its hearings. At the IOM's request, CIRM sent emails about the questionnaires to the 4,039 persons who have asked the agency to be notified about its RFAs. Recipients were asked by CIRM to complete the IOM surveys.

The online forms are due by April 23. Here are links in the various categories:  general public, CIRM investigators,CIRM industry partners, leadership from CIRM-funded institutions, technology transfer professionals,CIRM's international collaborators, members of the Independent Citizens' Oversight Committee (the CIRM governing board), and investigators not funded by CIRM.

The IOM said access to the Internet audiocast of the meeting can be gained on April 10 through this web page.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Chuck Winner is a name that doesn't surface often in connection with California's $3 billion stem cell research effort.

Chuck Winner (left) at USC in 2006 USC Photo

In fact, he rarely appears in the news. Winner's name, however, did surface yesterday when Gov. Jerry Brown appointed him to the state's horse racing board. Most of the stories about the appointment were in horse racing publications. But none, including The Sacramento Bee's, mentioned the Prop. 71 campaign managed by his firm, Winner & Mandabach Campaigns of Santa Monica, Ca.

Nonetheless, he and his firm were the key to winning approval of the 2004 ballot measure that created the California Institute of Regenerative Medicine, an enterprise that is unprecedented in state or national history.

The firm's $35 million campaign for Prop. 71 attracted 59 percent of the vote. That same year, the firm also successfully managed four other ballot measures in the Golden State. Its lifetime average is remarkable. The firm's web site says it has won 90 percent of the 150 ballot measure campaigns it has run throughout the country.

Winner-Mandabach has this to say about how it pulled off the Prop. 71 campaign:

"Surveys (in 2003-04) showed that most voters supported the basic concept of expanding stem cell research. However, because of the state’s serious budget and debt problems, it was also clear that passing such a huge bond measure for any purpose would be a major challenge.

"The campaign overseen by Winner & Mandabach to overcome those odds involved a year-long coalition building effort that ultimately recruited over 40 Nobel Prize winning scientists and more than 100 patient groups, disease foundations and business groups – the largest, most diverse coalition of its kind ever formed to support a state ballot measure. The supporting groups helped mount an intense grassroots outreach and activation effort to their members, who numbered in the millions."

Winner-Mandabach continued,

"The TV advertising developed by the firm featured award-winning scientists, patients and their families, and highly-respected patient advocates like Michael J. Fox and the late Christopher Reeve. The ads focused on the potential for cures that could save millions of lives. Details of the initiative and economic issues were addressed through in-depth mail pieces and earned media efforts that included the release of an economic study showing that stem cell cures would help reduce the state’s skyrocketing health care costs. Prior to the implementation of the paid media campaign in late-September, polling showed Proposition 71 below the 50% threshold. But after an intense 6-week advertising, earned media and grassroots campaign, Prop. 71 steadily gained support, even in the face of final attacks by conservative groups and activists like Mel Gibson, and attacks from the left by some anti-biotech groups. Because of its precedent-setting nature, the Prop. 71 campaign became the most watched ballot measure campaign in the nation and generated worldwide press attention. On election day, it was approved overwhelmingly by a vote of 59% to 41%."

The key to success on any ballot measure is a firm like Winner-Mandabach, although high profile individuals – in the case of Prop. 71, Robert Klein, who became the first chairman of the stem cell agency – are often given complete credit. Top notch campaign firms have a keen understanding of voters, appropriate political timing and effective PR and TV advertising campaigns. Without Winner-Mandabach – or a firm with the same skillset – the California stem cell agency would not exist.

Chuck Winner, however, does not have an uncritical view of the ballot initiative process, which has resulted in much expensive mischief in California. He told a USC audience in 2006,

"It’s abused time and again. My opinion is that when you circumvent the legislative process or representative democracy to solve a problem, you can take it to an extreme and that extreme becomes, in some ways, worse than the problem you were trying to solve in the first place. Single-issue up or down initiative votes are very often not the best way to govern."

As for the horse racing business, Winner, a Beverly Hills resident, has been involved in horse racing since 1986. His partner, Paul Mandabach, is also involved in the sport of kings. Their firm has not disclosed their record at the track.

(Click here to see two powerful ads developed for the 2004 campaign, including the famous Christopher Reeve spot.)

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

SAN FRANCISCO – A proposed $17.9 million operational budget for the California stem cell agency has cleared a key hurdle despite objections concerning the addition of another attorney to its $2.4 million annual legal effort.

The spending plan was approved yesterday by the CIRM directors' Finance Subcommittee on an 8-0 vote. The proposal is 7.2 percent higher than spending for the current fiscal year, which ends in June. The agency by law operates with a stringent budget cap of 6 percent of its bond funding.

Most of the budget goes for salaries at the agency, which has slightly more than 50 employees. The agency spends $8.4 million annually administering its 400-plus grants and developing new grant programs.

The proposal to add another lawyer to its staff drew fire from CIRM Co-vice chairman Art Torres. He asked why the agency wanted to spend more money for "a lawyer we don't need."

CIRM President Alan Trounson and CIRM General Counsel Elona Baum defended the plan, saying another lawyer was needed to deal with intellectual property and research commercialization issues. They said that grantee institutions and businesses are not dealing with the legal ramifications in a satisfactory manner.

Trounson said the agency would be "at risk" if it did not have control of the legal issues.

Torres brought up a memo on the subject, which he said did not justify the addition of a lawyer. Other directors said they had not seen the memo and asked for copies. The California Stem Cell Report has also asked for a copy.

Michael Goldberg, a venture capitalist and chair of the Finance Subcommittee, asked CIRM staff and a handful of directors to resolve the matter between now and the end of May, when the budget is expected to be approved by the full board.

Currently CIRM has five attorneys on staff, not including directors who are lawyers. The budget for the internal legal operation is $1.3 million annually. The rest of the $2.4 million goes for contracted services, including the firm of Remcho, Johansen & Purcell of San Leandro, Ca., a highly regarded political and governmentally oriented law firm that is budgeted for as much as $650,000 for the coming year, down from $695,000 this year. Another attorney is also on contract for $250,000, down from $325,000 this year.

CIRM budget documents projected savings in $190,000 in legal costs from the current year that could be used to help hire another attorney. The total legal costs for next year are budgeted at $2.44 million, compared to $2.39 million for the current year.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

SAN FRANCISCO -- The California stem cell agency scored during the weekend in a front page story in the San Francisco Chronicle that heralded a possible cancer treatment involving a "don't-eat-me-molecule."

The piece by Victoria Colliver said,

"In a potential breakthrough for cancer research, Stanford immunologists discovered they can shrink or even get rid of a wide range of human cancers by treating them with a single antibody."

The story was played prominently on the Chronicle front page on Saturday. However, the stem cell agency and its funding role was not mentioned until the last paragraph of the story. Nonetheless, on Saturday night, the Chronicle website reported that it was the most read and most emailed story on its site at that time.

When we looked at the story that evening, the article had 84 comments from readers, including several which praised the agency for its work. One reader noted, however, that other funding agencies were involved besides the California stem cell agency. The reader quoted from the Stanford press release, which said,

"This work was supported by the Joseph & Laurie Lacob Gynecologic/Ovarian Cancer Fund, the Jim & Carolyn Pride Fund, the Virginia & D.K. Ludwig Fund for Cancer Research, the Weston Havens Foundation, the National Cancer Institute, the Department of Defense, the California Institute for Regenerative Medicine and anonymous donors."

Stanford's news release said,

"It is the first antibody treatment shown to be broadly effective against a variety of human solid tumors, and the dramatic response — including some overt cures in the laboratory animals — has the investigators eager to begin phase-1 and –2 human clinical trials within the next two years."

The Los Angeles Times also carried a story last week on the research, but did not mention CIRM. The agency itself wrote about the research on its blog.

CIRM Chairman J.T. Thomas and other CIRM directors have been concerned about the lack of coverage in the mainstream media – particularly favorable coverage – of the agency's work. When this writer was at a meeting yesterday afternoon at CIRM headquarters in San Francisco, Thomas pointedly presented a copy of the Chronicle front page, suggesting the article was worthy of note. Thomas is correct; the piece can certainly be counted as a favorable mention of the $3 billion research effort. Now it is up to CIRM and its new communications director, Kevin McCormack, who began work on Monday, to multiply the Chronicle piece many times over.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Public release date: 2-Apr-2012 [ | E-mail | Share ]

Contact: Jeremy Moore Jeremy.Moore@aacr.org 215-446-7109 American Association for Cancer Research

PHILADELPHIA -- Scientists may have discovered a new paradigm for immunotherapy against cancer by priming antibodies and T cells with cancer stem cells, according to a study published in Cancer Research, a journal of the American Association for Cancer Research.

"This is a major breakthrough in immunotherapy research because we were able to use purified cancer stem cells to generate a vaccine, which strengthened the potency of antibodies and T cells that selectively targeted cancer stem cells," said Qiao Li, Ph.D., a research assistant professor in the department of surgery at the University of Michigan.

Cancer stem cells are tumor cells that remain present, and ultimately resistant, after chemotherapy or radiation treatment. Scientists disagree on whether these cells have unique properties, but those who support the uniqueness idea have argued that these cells regenerate the tumors that lead to relapse.

Despite the similar name, cancer stem cells are distinct from embryonic stem cells, and the two avenues of research are separate.

For the current study, Li and colleagues extracted cancer stem cells from two immunocompetent mouse models and used them to prepare the vaccine.

"We found that these enriched cancer stem cells were immunogenic and far more effective as an antigen source compared with the unselected tumor cells normally used in previous immunotherapy trials," said Li. "The mechanistic investigations found that when antibodies were primed with cancer stem cells, they were capable of targeting cancer stem cells and conferring antitumor immunity."

The researchers also found that cytotoxic T lymphocytes harvested from cancer stem cell-vaccinated hosts were capable of killing cancer stem cells in vitro.

###

Read more here:
Cancer stem cell vaccine in development shows antitumor effect

By Ellen Cogen Lipton

We must continue the fight for regenerative medical research

Regenerative medical research is about hope and potential. It holds the promise for life-saving cures and treatments and could revolutionize medical treatment for hundreds of thousands of people throughout Michigan who are battling debilitating diseases such as Parkinson's and juvenile diabetes. Yet, less than four years after Michigan voters approved such research, factions are continuing to try to thwart this industry that could save and extend countless lives while boosting Michigan's economy.

Michigan voters spoke loud and clear that they support regenerative medical research in 2008 when they approved Proposal 2, which gave families the option to donate for medical research unsuitable or leftover embryos from fertility treatments that would otherwise be unavailable for research.

Last year, we saw just how low opponents of regenerative medical research will go to overturn the will of the people. An amendment was added to a Higher Education Appropriations bill that attempted to prevent life-saving research and derail the industry from taking hold in Michigan. While we defeated this ploy, it should serve as a rallying cry that our work to this important research is far from over.

That's why I'm committed to doing everything I can to keep this research growing in Michigan. Opponents are working against this development at a time when this industry is just beginning to gain momentum.

With our top-notch educational and research facilities, Michigan - Southeast Michigan in particular - is poised to become the epicenter of the emerging life sciences industry, attracting high-tech job providers from around the world. Building on our University Research Corridor and Oakland County's Medical Main Street, we have a great foundation to advance this industry and benefit from thousands of good-paying jobs and millions in investment.

The passage of Proposal 2 and our hosting of the prestigious World Stem Cell Summit sent the message around the world that Michigan is serious about regenerative medical research and is a great place for businesses to locate and grow. Crain's Detroit Business recently listed increasing medical tourism, creating a bio-pharmaceutical research and development hub, and becoming a center for research and medical facilities as one of the six areas Michigan must strengthen.

We have the opportunity to help make great strides in medicine while also creating good-paying jobs. We must stay focused on expanding Michigan's footprint in this growing industry. Together, we can provide hope and progress to hundreds of thousands of Michigan residents and people around the globe whose lives could be improved and potentially saved. To me, that's worth fighting for.

State Representative Ellen Cogen Lipton represents the 27th District (Berkley, Ferndale, Hazel Park, Huntington Woods and part of Oak Park.)

Go here to read the rest:
GUEST OPINION: We must promote regenerative research to save lives

Trial Provides Proof-of-Concept for Cell-Based Therapy in a Myelination Disorder

Company to Host Conference Call Today to Discuss Summary Results

NEWARK, Calif., April 2, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced preliminary evidence of progressive and durable donor-cell derived myelination in all four patients who underwent transplantation with the Company's proprietary HuCNS-SC(R) cells (purified human neural stem cells) in its clinical trial for Pelizaeus-Merzbacher disease (PMD), a rare hypo-myelination disorder in children. In addition, clinical assessment revealed small but measureable gains in motor and/or cognitive function in three of the four patients; the fourth patient remained clinically stable. The study was conducted by researchers at the University of California, San Francisco (UCSF).

A summary of the trial results were presented Saturday, March 31, at the 2012 European Leukodystrophy Association (ELA) Families/Scientists Meeting in Paris. The findings are being submitted for publication in a peer-reviewed scientific journal.

"The results from this Phase I study are meaningful and important," said study investigator Nalin Gupta, MD, PhD, UCSF associate professor of neurological surgery and pediatrics and chief of pediatric neurological surgery at UCSF Benioff Children's Hospital. "The safety and clinical outcomes a year after transplantation in this Phase I study, combined with durable radiological signals of myelin formation, provide objective evidence of a biological effect of HuCNS-SC transplantation that addresses the fundamental basis of the pathology in the brain of PMD patients. We also wish to recognize the families' contribution to this study. These advances would not be possible without their willingness to participate in this clinical research."

Patients with PMD have a defective gene, which leads to insufficient myelin in the brain. The disease occurs only in males, and those with the most severe form of the disease, connatal PMD, are significantly disabled from birth and usually die, within the first decade of life. The study was the first to test transplantation of neural stem cells as a potential treatment for a myelination disorder. Myelin is the substance that surrounds and insulates nerve cells' communications fibers (also known as axons). Without sufficient myelination, these fibers are unable to properly transmit nerve impulses, leading to a progressive loss of neurological function, and death.

The open-label Phase I trial, conducted between February 2010 and February 2012, enrolled four patients with the connatal form of PMD, between the ages of 14 months and 5 years, and was designed to assess safety and preliminary efficacy of the intervention. The study used magnetic resonance (MR) imaging, commonly employed in other neurological diseases, to explore signs of myelination related to the transplanted neural stem cells. The HuCNS-SC transplants were surgically delivered to multiple sites within the frontal lobes of the brain. Patients also received immunosuppression for nine months following transplantation and underwent intensive follow-up neurological assessments and MR imaging for twelve months following transplantation. A separate four-year observational study will continue to monitor and report the future progress for all four patients.

At the one-year interval, MR imaging showed changes compatible with increased myelination in the region of the transplantation. The MR signs of myelination persisted after the withdrawal of immunosuppression at nine months and were also found to progress over time. The development of new myelin signals is unprecedented in patients with connatal PMD and is consistent with HuCNS-SC engraftment.

"The finding of myelin formation in this first exploratory study is indeed very encouraging," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "We believe that the results of this trial provide proof-of-concept and a compelling rationale for the Company to begin planning for a controlled Phase II study in PMD. These results may also have implications for other leukodystrophies, as well as more common myelin disorders including transverse myelitis, multiple sclerosis and periventricular white matter injury seen in Cerebral Palsy. We are very pleased to be working with investigators at UCSF and deeply appreciate the critical research expertise they have dedicated to the trial."

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StemCells, Inc's Milestone Clinical Trial in Pelizaeus-Merzbacher Disease Shows Evidence of Myelination Following ...

ScienceDaily (Apr. 1, 2012) The latest research developments to reprogram scar tissue resulting from myocardial infarction (MI) into viable heart muscle cells, were presented at the Frontiers in CardioVascular Biology (FCVB) 2012 meeting, held 30 March to 1 April at the South Kensington Campus of Imperial College in London.

In a keynote lecture Dr Deepak Srivastava outlined his approach that has been described as a "game changer" with the potential to revolutionise treatment of MI. For the first time at the FCVB meeting, Srivastava presented the results of his latest studies using viral vectors to deliver genes directly into the hearts of adult mice that had experienced an MI. The FCVB meeting was organised by the Council on Basic Cardiovascular Science (CBCS) of the European Society of Cardiology (ESC).

In his original "proof of principle" study, published August 2010 in Cell, Srivastava was able to show that all that was needed for the direct reprogramming of fibroblasts (a major component of scar tissue) into myocytes (heart muscle cells responsible for beating) was the delivery of three genes.

The work , which took place in a Petri dish, was considered groundbreaking since it showed for the first time that unrelated adult cells could be reprogrammed from one cell type to another without having to go all the way back to a stem cell state.

"Our ultimate hope is that, during the acute period following MI, patients will be able to receive direct injections of factors that transform the existing fibroblast cells in the "scar" into new myocytes. The resulting increase in muscle mass should help MI survivors to live more normal lives," explained Srivastava, who is director of the Gladstone Institute of Cardiovascular Disease in San Francisco, US.

Healthy heart tissue is composed of a mixture of several kinds of cells, including cardiomyocytes, which provide beating muscle, and cardiac fibroblasts, that provide architectural support to the myocytes. "When heart muscle cells become injured and die following an MI, patients have the major problem that these cells have little or no capacity for regeneration," explained Srivastava. Part of the process of remodelling that occurs following the injury is that fibroblast cells migrate to the site and create the scar.

"The process at first can be considered beneficial since without fibroblasts adding structural support damaged hearts would rupture. But later difficulties arise when the fibrotic scar doesn't contract like the muscle it has replaced. Reduced global contractility means the heart has to work much harder, and the extra stress can ultimately lead to heart failure and even death," said Srivastava.

One of the Holy Grails of cardiovascular research has been to replace these lost myocytes and return functionality to the heart. Some of the first approaches to be investigated were the introduction of stem or progenitor cells to the sites of injury.

"But many hurdles have been encountered including getting cells to integrate with neighbouring cells in the heart, and there have been concerns that residual "rogue" cells could persist with the potential to keep dividing and give rise to tumours," said Srivastava. "Harnessing the vast reservoir of fibroblasts already present in the heart, we felt, could overcome many of these issues. They've the big advantage they're already present in the organ and closely integrated with neighbouring cells."

In the address Srivastava, a paediatric cardiologist, explained how he had first got ahead of the game by "leveraging" knowledge from his work in embryo hearts. Over the past 15 years the focus of Srivastava's lab has been to identify genetic factors responsible for the formation of embryonic hearts.

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Transforming scar tissue into beating hearts: The next instalment

Public release date: 1-Apr-2012 [ | E-mail | Share ]

Contact: James Hathaway jbhathaw@uncc.ed 704-687-5743 University of North Carolina at Charlotte

New research shows it may be no accident when doctors observe how patients suffering from both breast cancer and arthritis seem to have more aggressive cancer. However, the new-found interaction between the two diseases may also suggest a possible treatment.

A potential relationship between metastatic breast cancer and autoimmune arthritis, as suggested by past epidemiological studies, has led researchers from the University of North Carolina at Charlotte to perform a series of mouse model experiments that appear to confirm the connection.

"Epidemiological studies have implied that breast cancer survival is significantly lower in patients who also had autoimmune arthritis," noted Pinku Mukherjee, Irwin Belk Distinguished Scholar of Cancer Research at UNC Charlotte, whose lab conducted the experiments. "As there is no obvious reason this should be so, we were interested in exploring possible cancer mechanisms that might explain why."

The experiments point to an intimate relationship between mast cells immune system cells that are located in various tissues and that can cause inflammation and metastatic tumors.

In previously published studies, UNC Charlotte cancer researcher Lopamudra Das Roy and her mentor Mukherjee established that breast cancer associated metastases were significantly higher in arthritic mice, with a threefold increase in lung metastases and a twofold increase in bone metastases.

In their most recent work, the researchers found that mast cells and their associated inflammation are present in larger numbers in the bones and lungs of arthritic mice than they are in non-arthritic mice. Their findings point to a relationship between the cKit receptor found on mast cells and the transmembrane stem cell factor (SCF) ligand found on metastatic breast cancer cells. The interaction between SCF and cKit appears to play a critical role in facilitating metastasis.

"We confirmed the relationship we suspected between autoimmune disease and metastastic breast cancer cells," Mukherjee said. "This is an exciting result for us because it confirms an interesting interdependence between cancer metastasis and a specific component of the immune system."

The study results will be presented by Lopamudra Das Roy, Research Assistant Professor at UNC Charlotte, and Mukherjee at the 2012 American Association for Cancer Research Annual Meeting in Chicago at a press conference on April 1.

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Mechanism found connecting metastatic breast cancer and arthritis

California's $3 billion stem cell agency, now more than 7 years old, has joined research partnerships with science and health agencies in eight foreign countries, the San Francisco institute announced.

The agreements call for collaboration in efforts aimed at speeding stem cell research from the laboratory to the hospital, where researchers hope that basic human cells will be programmed to treat scores of human degenerative diseases.

Research partnerships between American and foreign stem cell scientists are encouraged, but the California institute's funds would only be spent within the state, institute officials said.

Alan Trounson, president of the California Institute for Regenerative Medicine, signed agreements with stem cell funding agencies in Brazil and Argentina last week, he said Thursday.

"Both Brazil and Argentina have strong and robust stem cell research communities in basic science and transitional clinical science, which should create exciting synergies with many scientists in California," Trounson said in a statement.

He has signed similar pacts with stem cell agencies in Canada, Britain, France, Spain, Australia, Japan, China and Indiana.

The California institute was created in 2004 after Proposition 71, a $3 billion bond issue, was approved by California voters at a time when use of federal funds was barred for research into the promising field of embryonic stem cells.

So far the state agency has committed $1.2 billion to scientists and training centers at 56 California institutions, and the rest of the bond money should last until 2020, a spokesman said.

This article appeared on page C - 9 of the SanFranciscoChronicle

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Stem cell institute to work with foreign agencies

(HealthDay News) -- Obesity surgery-related complications in the United States declined 21 percent between 2001 and 2006, and payments to hospitals for obesity surgery decreased by as much as 13 percent, partly because there were fewer patient readmissions due to complications, a new study reports.

The findings from a study by the U.S. Agency for Healthcare Research and Quality are based on an analysis of more than 9,500 patients under age 65 who had obesity surgery, also known as bariatric surgery, at 652 hospitals between 2001 and 2002 and between 2005 and 2006.

The researchers found that the complication rate among obesity surgery patients dropped from 24 percent to about 15 percent. Contributing to that decrease were declines in post-surgical infection rates (58 percent lower), abdominal hernias, staple leakage, respiratory failure and pneumonia (29 percent to 50 percent lower).

There was little change in rates of other complications such as ulcers, dumping (involuntary vomiting or defecation), hemorrhage, wound re-opening, deep-vein thrombosis and pulmonary embolism, heart attack and stroke, the researchers noted. Read more...

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