StemCell Therapy

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

Contact: Charles Casey charles.casey@ucdmc.ucdavis.edu 916-734-9048 University of California - Davis Health System

UC Davis Health System researchers are a step closer to launching human clinical trials involving the use of an innovative stem cell therapy to fight the virus that causes AIDS.

In a paper published in the May issue of the Journal of Virology, the UC Davis HIV team demonstrated both the safety and efficacy of transplanting anti-HIV stem cells into mice that represent models of infected patients. The technique, which involves replacing the immune system with stem cells engineered with a triple combination of HIV-resistant genes, proved capable of replicating a normally functioning human immune system by protecting and expanding HIV-resistant immune cells. The cells thrived and self-renewed even when challenged with an HIV viral load.

"We envision this as a potential functional cure for patients infected with HIV, giving them the ability to maintain a normal immune system through genetic resistance," said lead author Joseph Anderson, an assistant adjunct professor of internal medicine and a stem cell researcher at the UC Davis Institute for Regenerative Cures. "Ideally, it would be a one-time treatment through which stem cells express HIV-resistant genes, which in turn generate an entire HIV-resistant immune system."

To establish immunity in mice whose immune systems paralleled those of patients with HIV, Anderson and his team genetically modified human blood stem cells, which are responsible for producing the various types of immune cells in the body.

Building on work that members of the team have pursued over the last decade, they developed several anti-HIV genes that were inserted into blood stem cells using standard gene-therapy techniques and viral vectors (viruses that efficiently insert the genes they carry into host cells). The resulting combination vector contained:

a human/rhesus macaque TRIM5 isoform, which disrupts HIV from uncoating in the cytoplasm a CCR5 short hairpin RNA (shRNA), which prevents certain strains of HIV from attaching to target cells a TAR decoy, which stops HIV genes from being expressed inside of the cell by soaking up a critical protein needed for HIV gene expression These engineered blood stem cells, which could be differentiated into normal and functional human immune cells, were introduced into the mice. The goal was to validate whether this experimental treatment would result in an immune system that remained functional, even in the face of an HIV infection, and would halt or slow the progression toward AIDS.

The results were successful on all counts.

"After we challenged transplanted mice with live HIV, we demonstrated that the cells with HIV-resistant genes were protected from infection and survived in the face of a viral challenge, maintaining normal human CD4 levels," said Anderson. CD4+ T-cells are a type of specialized immune cell that HIV attacks and uses to make more copies of HIV.

Read the rest here:
Study using stem cell therapy shows promise in fight against HIV

ScienceDaily (May 2, 2012) UC Davis Health System researchers are a step closer to launching human clinical trials involving the use of an innovative stem cell therapy to fight the virus that causes AIDS.

In a paper published in the May issue of the Journal of Virology, the UC Davis HIV team demonstrated both the safety and efficacy of transplanting anti-HIV stem cells into mice that represent models of infected patients. The technique, which involves replacing the immune system with stem cells engineered with a triple combination of HIV-resistant genes, proved capable of replicating a normally functioning human immune system by protecting and expanding HIV-resistant immune cells. The cells thrived and self-renewed even when challenged with an HIV viral load.

"We envision this as a potential functional cure for patients infected with HIV, giving them the ability to maintain a normal immune system through genetic resistance," said lead author Joseph Anderson, an assistant adjunct professor of internal medicine and a stem cell researcher at the UC Davis Institute for Regenerative Cures. "Ideally, it would be a one-time treatment through which stem cells express HIV-resistant genes, which in turn generate an entire HIV-resistant immune system."

To establish immunity in mice whose immune systems paralleled those of patients with HIV, Anderson and his team genetically modified human blood stem cells, which are responsible for producing the various types of immune cells in the body.

Building on work that members of the team have pursued over the last decade, they developed several anti-HIV genes that were inserted into blood stem cells using standard gene-therapy techniques and viral vectors (viruses that efficiently insert the genes they carry into host cells). The resulting combination vector contained:

These engineered blood stem cells, which could be differentiated into normal and functional human immune cells, were introduced into the mice. The goal was to validate whether this experimental treatment would result in an immune system that remained functional, even in the face of an HIV infection, and would halt or slow the progression toward AIDS.

The results were successful on all counts.

"After we challenged transplanted mice with live HIV, we demonstrated that the cells with HIV-resistant genes were protected from infection and survived in the face of a viral challenge, maintaining normal human CD4 levels," said Anderson. CD4+ T-cells are a type of specialized immune cell that HIV attacks and uses to make more copies of HIV.

"We actually saw an expansion of resistant cells after the viral challenge, because other cells which were not resistant were being killed off, and only the resistant cells remained, which took over the immune system and maintained normal CD4 levels," added Anderson.

The data provided from the study confirm the safety and efficacy of this combination anti-HIV lentiviral vector in a hematopoietic stem cell gene therapy setting for HIV and validated its potential application in future human clinical trials. The team has submitted a grant application for human clinical trials and is currently seeking regulatory approval, which is necessary to move on to clinical trials.

Continued here:
Stem cell therapy shows promise in fight against HIV

South San Francisco, CA (Marketwire) - VistaGen Therapeutics, Inc. (OTCBB: VSTA) (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue, has secured a new United States patent covering the company's proprietary methods used to measure and type the toxic effects produced by drug compounds in liver stem cells.

Test methods included in this new patent, (U.S. Patent 11/445,733), titled "Toxicity Typing Using Liver Stem Cells," cover all mammalian liver stem cells -- rat and mouse cells, for example, in addition to human cells. Liver stem cells used in drug testing can be derived from in vivo tissue or produced from embryonic stem cells (ES) or induced pluripotent stem cells (iPS).

H. Ralph Snodgrass, Ph.D., VistaGen's President and Chief Scientific Officer, said, "This patent covers the monitoring of changes in gene expression as an assay for predicting drug toxicities. It is well known that drugs activate and suppress specific genes, and that the changes in gene expression reflect the mechanism of drug toxicities. The specific sets of genes that are affected become a profile of that drug."

VistaGen's new patent also covers techniques used to develop a database of gene expression profiles of drugs that have the same type of liver toxicity. Using sophisticated "pattern matching" database tools, drug developers can analyze these related profiles to determine "gene expression signatures" that are common and predictive of drugs that produce specific types of toxicity.

"Without this database capability, a drug's single gene expression profile could not be interpreted," Dr. Snodgrass added. "The ability to use liver stem cells to differentiate drug-dependent gene expression profiles, and to compare those profiles of drugs known to induce toxic liver effects, provides a powerful tool for predicting liver toxicity of new drug candidates, including drug rescue variants."

Shawn K. Singh, VistaGen's Chief Executive Officer, stated, "Strong and enforceable intellectual property rights are critical components of our plan to optimize the commercial potential of our Human Clinical Trials in a Test Tube platform. This new liver toxicity typing patent further solidifies our growing IP portfolio, and supports the continuing development of LiverSafe 3D, our human liver cell-based bioassay system, which complements our CardioSafe 3D human heart cell-based bioassay system for heart toxicity."

About VistaGen Therapeutics VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, with modern medicinal chemistry to generate new chemical variants (Drug Rescue Variants) of once-promising small-molecule drug candidates. These are drug candidates discontinued due to heart toxicity after substantial development by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

Additionally, VistaGen's small molecule drug candidate, AV-101, is in Phase 1b development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. VistaGen is also exploring opportunities to leverage its current Phase 1 clinical program to enable additional Phase 2 clinical studies of AV-101 for epilepsy, Parkinson's disease and depression. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101. Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen

Cautionary Statement Regarding Forward Looking Statements The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals, the issuance and protection of patents and other intellectual property, the success of VistaGen's ongoing clinical studies, including the safety and efficacy of its drug candidate, AV-101, the failure of future drug rescue and pilot preclinical cell therapy programs related to VistaGen's stem cell technology-based Human Clinical Trial in a Test Tube platform, its ability to enter into drug rescue collaborations, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen's research, development and commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variants identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

SOURCE: VistaGen Therapeutics, Inc.

More:
VistaGen Secures Key U.S. Patent Covering Stem Cell Technology Methods Used To Test Drug Candidates For Liver Toxicity

MONTREAL, QUEBEC--(Marketwire -04/30/12)- With a shared goal of supporting development projects that will boost innovation in the growing field of stem cells and biomaterials-based products, Pfizer Canada and the Centre for Commercialization of Regenerative Medicine (CCRM) have established the Pfizer-CCRM Innovation Fund to accelerate regenerative medicine (RM) technologies for drug screening and therapeutic applications. The announcement is being made at the first annual Till & McCulloch Meetings (April 30-May 2), Canada's premier stem cell meeting, jointly hosted by the Stem Cell Network and CCRM.

"CCRM was created on the premise that it would work with academia and industry on projects that will hopefully move RM technologies and innovations from the bench to the bedside," says Michael May, CEO of CCRM. "Canada is already a leader in this field and additional funding to advance novel research through early product development will only make us stronger. We're very pleased to be partnering with Pfizer Canada and appreciate their confidence in joining with us."

"Pfizer Canada is pleased to contribute to this new fund which will support important research here in Canada," explains Dr. Bernard Prigent, Vice-President and Medical Director, Pfizer Canada. "With the novel resources offered through CCRM's development capabilities, we hope to help advance the RM field in this country."

Pfizer Canada has contributed a total of $500,000 to the Pfizer-CCRM Innovation Fund and CCRM will contribute matching dollars to any approved projects undertaken in the duration of this fund.

About Centre for Commercialization of Regenerative Medicine (CCRM)

CCRM, a Canadian not-for-profit organization funded by the Government of Canada's Networks of Centres of Excellence program and six institutional partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM translates scientific discoveries into marketable products for patients. CCRM launched in Toronto's Discovery District on June 14, 2011.

About Pfizer Canada

Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., the world's leading biopharmaceutical company. Pfizer discovers, develops, manufactures and markets prescription medicines for humans and animals. Pfizer Inc. invests more than US$7 billion annually in R&D to discover and develop innovative life-saving and life-enhancing medicines in a wide range of therapeutic areas. Our diversified health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. For more information, visit http://www.pfizer.ca

Here is the original post:
New Fund Established to Stimulate Regenerative Medicine Industry

--Study lends support to safe use for therapy

Newswise A team of researchers from Johns Hopkins University and the National Human Genome Research Institute has evaluated the whole genomic sequence of stem cells derived from human bone marrow cellsso-called induced pluripotent stem (iPS) cellsand found that relatively few genetic changes occur during stem cell conversion by an improved method. The findings, reported in the March issue of Cell Stem Cell, the official journal of the International Society for Stem Cell Research (ISSCR), will be presented at the annual ISSCR meeting in June.

Our results show that human iPS cells accrue genetic changes at about the same rate as any replicating cells, which we dont feel is a cause for concern, says Linzhao Cheng, Ph.D., a professor of medicine and oncology, and a member of the Johns Hopkins Institute for Cell Engineering.

Each time a cell divides, it has the chance to make errors and incorporate new genetic changes in its DNA, Cheng explains. Some genetic changes can be harmless, but others can lead to changes in cell behavior that may lead to disease and, in the worst case, to cancer.

In the new study, the researchers showed that iPS cells derived from adult bone marrow cells contain random genetic changes that do not specifically predispose the cells to form cancer.

Little research was done previously to determine the number of DNA changes in stem cells, but because whole genome sequencing is getting faster and cheaper, we can now more easily assess the genetic stability of these cells derived by various methods and from different tissues, Cheng says. Last year, a study published in Nature suggested higher than expected cancer gene mutation rates in iPS cells created from skin samples, which, according to Cheng, raised great concerns to many in the field pertaining to usefulness and safety of the cells. This study analyzed both viral and the improved, nonviral methods to turn on stem cell genes making the iPS cells

To more thoroughly evaluate the number of genetic changes in iPS cells created by the improved, non-viral method, Chengs team first converted human blood-forming cells or their support cells, so-called marrow stromal cells (MSCs) in adult bone marrow into iPS cells by turning on specific genes and giving them special nutrients. The researchers isolated DNA from--and sequenced--the genome of each type of iPS cells, in comparison with the original cells from which the iPS cells were derived.

Cheng says they then counted the number of small DNA differences in each cell line compared to the original bone marrow cells. A range of 1,000 to 1,800 changes in the nucleic acid letters A, C, T and G occurred across each genome, but only a few changes were found in actual genes--DNA sequences that act as blueprints for our bodys proteins. Such genes make up two percent of the genome.

The blood-derived iPS cells contained six and the MSC-derived iPS cells contained 12 DNA letter changes in genes, which led the researchers to conclude that DNA changes in iPS cells are far more likely to occur in the spaces between genes, not in the genes themselves.

Next, the investigators examined the severity of the DNA changes--how likely each one would disrupt the function of each gene. They found that about half of the DNA changes were silent, meaning these altered blueprints wouldnt change the nucleic acid building code for its corresponding protein or change its function.

Link:
Improved Adult-Derived Human Stem Cells Have Fewer Genetic Changes Than Expected

SOURCE: American CryoStem Corporation

RED BANK, NJ--(Marketwire - Apr 30, 2012) - American CryoStem Corporation (OTCQB: CRYO) announced the launch of its new adipose tissue and adult stem cell testing services to assist physicians involved in tissue engraftment, regenerative medicine procedures and cellular therapies utilizing adult adipose derived stem cells. The new testing services provide physicians an affordable method for self assessment of their procedures and methods to better understand the relationship between tissue quality and engraftment success.

American CryoStem recognizes the need for independent testing services as reinforced by the increasing focus and scrutiny of physician office based tissue laboratories by the US Food and Drug Administration (FDA). The menu of testing services includes full 14 day sterility testing, viability testing, growth assay and additional tests for each selected service. The tests can be ordered individually or in multiples over time and are designed to allow physicians to self evaluate their current methods and performance, or to assess new methods or devices designed to improve procedure and tissue quality. Long term and customized programs are available upon request. Physicians enrolled as a provider of the Company's stem cell storage services can obtain discounts for individual and multi test programs.

"We are very excited about rolling these new services out to our existing providers and all participants in the tissue engraftment, regenerative medicine and cellular therapy markets. We believe that this is the first such program offered commercially and meets a critical need for the advancement of the regenerative and cellular therapy markets," said Anthony Dudzinski, the Company's COO. "Now there is a way for physicians to assess their own performance without the need to overcome the significant costs of purchasing and maintaining their own testing facilities."

The new testing services are offered by ACS Laboratories reflects the Company's increasing branding and commercialization of products and services developed around its proprietary clinical tissue processing and storage methodologies. ACS Laboratory incorporates its proprietary cGMP/cGTP aseptic methods and FDA guidance's into these services to ensure the highest quality and most useful information for physicians.

About American CryoStem: American CryoStem Corporation (OTCQB: CRYO) markets clinical processing services and patented products for Adipose (fat) Tissue and Adipose Derived Adult Stem Cells. The Company's clinical processing, patented cell culture media products and cellular preservation platform supports the science and regenerative medicine applications being developed globally. The Company provides the highest quality, clinically processed cells assuring their purity, viability and growth capabilities, while at the same time developing cutting edge applications, therapies and patented laboratory products and services for consumer and commercial applications.

Link:
American CryoStem Announces ACS Laboratories Adipose Tissue and Adult Stem Cell Testing Services

NES ZIONA, Israel--(BUSINESS WIRE)--

Kadimastem, an Israeli Biotechnology company that develops human pluripotent stem cell-related products, today announced the signing of a five year framework agreement with Merck Serono, a division of Merck KGaA, Darmstadt, Germany. The agreement concerns the use of Kadimastem's drug-screening platform to discover new oral drugs for the treatment of the neurological disease Multiple Sclerosis (MS).

The system developed by Kadimastem allows using human functional tissues produced industrially from pluripotent stem cells as a means to search for potential new drugs, a direct approach that has advantages over the use of animals. In Multiple Sclerosis, the insulating myelin sheaths which cover many nerves in the brain and spinal cord are destroyed due to loss of the myelin-forming cells resulting in the impairment of nerve function and severe neurological disabilities. It is estimated that 2.5 million patients suffer from this disease around the globe. While the existing treatments act by slowing down the loss of myelin-forming cells, there is great interest in finding new medications that could repair the myelin by stimulating the regeneration of myelin-forming cells. The drug-screening project, to be carried out through the Kadimastem-Merck Serono agreement, aims precisely at the discovery of potential oral drugs that act by stimulating myelin repair.

We are pleased to announce this agreement with Merck-Serono, a company with robust experience in drug discovery, development and marketing in the Multiple Sclerosis area, said Mr. Yossi Ben-Yossef, CEO of Kadimastem. The undisclosed compensation for this agreement will provide financial support for Kadimastem's own in-house drug discovery initiatives, in the field of neurodegenerative diseases as well as in the field of Diabetes. Kadimastem also produces pancreatic islet cells from pluripotent stem cells, for screening of drugs enhancing insulin secretion and eventually for cellular therapy of Diabetes.

Prof. Michel Revel, Chief Scientist of Kadimastem, further commented: We are very proud that after a thorough evaluation, Merck Serono decided to sign an agreement with us. We see it as a proof of our excellence in developing human myelin-forming cells and our capabilities in drug screening. We believe that this agreement is a first step towards further collaboration with Merck Serono and other Pharmaceutical companies, in which our capabilities in drug screening on human functional cell systems will synergize with their capabilities in medicinal chemistry and clinical development, to make drugs available more rapidly and more efficiently.

Prof. Revel from the Weizmann Institute of Science was the Chief Scientist of InterPharm, an Israeli biotech company part of the Merck Serono group that developed Prof. Revel's groundbreaking research which lead to Rebif (mammalian cell-produced recombinant Interferon beta-1a), today a leading drug for the treatment of Multiple Sclerosis with annual sales by Merck Serono of over US$ 2.3 billion.

Mr. Amir Naiberg, CEO of Yeda, the commercial arm of the Weizmann Institiute of Science, said: We are excited that Kadimastem, that was established around one of our technologies, is collaborating with Merck Serono. Merck Serono has a long and successful tradition of developing products that emerged from the Weizmann Institute labs,and we hope that Kadimastem will be another link in this chain.

About Kadimastem

Kadimastem (www.kadimastem.com) is a biotechnology company focused on the industrial development and commercialization of human pluripotent stem cell-based products. At Kadimastem, the pluripotent stem cell technology is used to produce specialized human cells and tissues for two major types of medical applications: 1) Drug-screening platforms using human functional cells and tissues as in vitro assays for discovering novel therapeutic drugs for neurological diseases and diabetes, and 2) Cell therapy for regenerative medicine, to repair tissues and organs affected by diseases, such as implanting insulin-secreting pancreatic islet cells as a treatment for insulin-dependent diabetes. Kadimastem is developing these technologies in its state of the art 1,000 m2 facilities in the Weizmann Science Park (Ness Ziona, Israel), for industrial research and production, with a staff of PhD-level and MSc-level scientists. Kadimastem uses pluripotent human stem cells made available through licensing agreements with the Embryonic Stem Cell Center of the Hadassah Medical center in Jerusalem (Prof. Benjamin Reubinoff) and the Shaarei Zedek Medical Center, Jerusalem, Israel.

About Merck Serono

Link:
Pharmaceutical Company Merck Serono Signs an Agreement to Use Kadimastem's Platform for Drug Screening

Eliminating smoking at home reduces the risk of sudden infant death syndrome (SIDS) by 80 percent, an Australian study has found.

Research from the University of Sydney has proven a link between noxious fumes and SIDS. It found nicotine, the main neurotoxin found in cigarette smoke, increased the risk of SIDS by damaging brain stem cells receptive to the drug.

The results, published in the journal of Toxicology and Applied Pharmacology, followed up on the research team's previous 2007 study of babies who died of SIDS that proved any smoke exposure contributed to brain cell death.

Of the 67 babies who died of SIDS in the research group, 81 percent were exposed to cigarette smoke.

International studies have shown the babies of mothers who smoke during pregnancy have a five-fold increase in the risk of SIDS, while babies born into a home where there is a smoker have a three-fold risk.

"We found any smoke exposure in the home resulted in a greater number of cells dying in the brain stem which controls heart rate, respiration and sleep and arousal," researcher Dr. Rita Machaalani said.

The incidence of SIDS has decreased by 85 percent in the past 25 years due to safe sleep education programs that recommend babies be placed on their backs to sleep.

Almost one in five women still smoke in pregnancy, including 42 percent of teenagers and 52 percent of indigenous women.

"The most outstanding risk factor is tobacco smoke and it's one of the hardest ones to shake," Ros Richardson, from SIDS and Kids NSW, said.

"Smoking in pregnancy is also associated with a higher risk of stillbirth and pre-term birth and neonatal loss."

See the original post here:
Study finds smoking leads to increase in sudden infant death syndrome

When Tyler was born, the umbilical cord was wrapped around his neck, causing a lack of oxygen to his brain that led to Tyler suffering a stroke during delivery. The stroke caused damage to the back of Tylers brain. Tyler was diagnosed with cerebral palsy and his mother, Lisa Biermann, was told to expect the worst: a child who would never walk, talk, or have any chance at a normal life.

Lisa refused to give up hope. She tried everything she could to help Tyler. Tyler could not walk because his feet would not sit flat on the floor. She tried botox injections every three months, braces, casts and even ankle cord surgery. Nothing worked.

Lisa said Tyler could not communicate with her at all. She never knew when he was in pain because he was unable to tell her.

Tyler was considered to be blind, with a prescription that was over nine units nearsighted, and his eyes jumped around. Even with glasses, he could not focus his vision, and doctors did not believe he could see, or ever would see.

Until he was 8 years old, Lisa would carry Tyler from his classes at Woodland Park Elementary.

When Tyler was 8, he had a seizure. Dr. David Steenblock, who is based in California, heard about Tyler and offered to help him with umbilical cord stem cell therapy. Lisa said she thought hard about it, and because she had tried everything else and nothing had worked, she decided to try the stem cell therapy, which Dr. Steenblock told her had no side effects.

In December 2007, Lisa, Dr. Steenblock and his team took Tyler for the treatment, which had to be done in Tijuana, Mexico, because stem cells injection is currently not legal in the United States. Three months later, they went for a second injection.

The stem cells were given to Tyler intravenously for a period of approximately 45 minutes.

Lisa said within weeks, she saw monumental changes in Tyler. All the milestones he never reached as a baby, he began reaching.

Within three months Tyler could put his feet flat on the floor and could walk independently. At six months post-treatment, he no longer needed the painful braces that gave him bunions.

See the original post:
Stem cell therapy for WCMS student has remarkable results

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

The $3 billion California stem cell agency, which is moving to engage the biotech industry ever more closely, is proposing a major weakening of the financial disclosure requirements for its board of directors and executives.

The move comes as the agency is also seeking to raise cash from the private sector to continue the state research effort's existence.  CIRM's dimming of transparency runs counter to government trends nationally for more disclosure rather than less, including regulations enacted last year by the NIH.

The proposed changes will be considered next Thursday by the CIRM directors' Governance Subcommittee, which will have public teleconference sites in San Francisco and Irvine and two each in Los Angeles and La Jolla.

Currently CIRM board members and top executives must disclose all their investments and income – in a general way – along with California real property that they hold. Under the changes, disclosures would instead be required only "if the business entity or source of income is of the type to receive grants or other monies from or through the California Institute for Regenerative Medicine." CIRM offered no explanation of what it means by "of the type to receive" funds from the agency.

The proposal further narrows disclosure in connection with income or investments in enterprises that provide facilities or services used by CIRM. With the removal of the requirement for reporting all investments, CIRM's changes also specified disclosure of income and investments connected to business entities (nonprofits are not mentioned) that are engaged in biomedical research or the manufacture of biomedical pharmaceuticals.

The new code would appear to give CIRM directors and executives wide personal latitude in determining what should be disclosed. The current language simply states that "all" investments, etc., must be disclosed. That language originated in the 1974 ballot initiative that created the state disclosure requirements. The initiative's intent was to give the public and interested parties access to key information that would allow them to determine what forces are at work in government and whether conflicts of interests exist – as opposed to simply trusting the assertions of officials without additional substantiation.

The new code also appears to relieve CIRM officials of reporting investment in or income from venture capital or other firms that may be engaged in financing biotech or stem cell enterprises, since the firms do not receive cash from CIRM or engage in biomedical research.

While the code appears to provide more reporting freedom for board members and executives, it also may indirectly impose a burden on them to determine whether any of their investments may involve biomedical research or enterprises that could possibly receive funds from CIRM at some point

Earlier this week, the California Stem Cell Report asked the stem cell agency about such issues. Kevin McCormack, CIRM's new senior director of public communications and patient advocate outreach, replied that the changes were "proposed" by the state Fair Political Practices Commission, which oversees state disclosure laws.

He said the FPPC says agencies "should tailor their disclosure categories to type of work performed by the agency."

McCormack cited as examples the State Board of Education and the state retirement system.

As for the specific changes in CIRM's code, McCormack said,

"Because these are the types of entities that are likely to create potential conflicts of interest, we believe the disclosure categories are appropriate."

McCormack did not comment on whether the proposed code would give board members more reporting latitude or whether it relieve them of reporting investments tied to the financing of biotech or stem cell firms. (The text of his response can be found here.)

The California Stem Cell Report is querying the FPPC concerning its policy regarding disclosure codes. CIRM's new code is expected to go before the the full CIRM board in late May. The changes are subject to review by the FPPC and then must formally go through the state administrative law process during which the public can comment and the code modified before final adoption.

Our take? The proposed changes are not in the best interests of CIRM or the people of California. The absence of transparency and disclosure only breeds suspicious speculation of the worst sort. The agency is already burdened by conflicts of interest that are built in by the ballot measure that created it in 2004. Nearly all of the $1.3 billion that CIRM has handed out has gone to institutions linked to CIRM directors. Weakening disclosure at a time when the biotech industry will become more closely tied to CIRM inevitably raises questions about financial linkages – present and future – between CIRM directors and executives and industry. For the past seven years, CIRM directors and staff have been able to comply with
more complete disclosure. They should continue to do so for the life of the agency, which will expire in less than a decade unless it finds additional sources of cash.

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

"In answer to your question, we
are proposing changes to the Conflict of Interest Code based upon
recommendations from the California Fair Political Practices
Commission (FPPC). The Political Reform Act requires state
agencies like CIRM to review their Conflict of Interest Codes every
two years.  The FPPC, which is charged with enforcing the
Political Reform Act, is responsible for reviewing and approving
CIRM's Conflict of Interest Code.  In preparation for this
review, CIRM's counsel met with the FPPC staff who suggested the
proposed amendments which are the subject of the upcoming Governance
Subcommittee meeting.  The proposed amendments to CIRM's
Conflict of Interest Code are consistent with the FPPC's position
that agencies should tailor their disclosure categories to type of
work performed by the agency.  For example, CalPERS's
conflict of interest code requires CalPERS officials to disclose
investments in, and income from, entities that are of the type with
which CalPERS contracts and entities in which funds administered by
CalPERS could be invested.  Likewise, the State Board of
Education requires its members to disclose investments, business
positions, and income from a publisher, manufacturer, or vendor of
instructional materials, or services offered to educational
institutions in the State of California and investments, positions of
management and income from any private school in the State of
California.  Similar to these codes, the FPPC proposed that
CIRM's Code be tailored to the nature of CIRM's work.  Thus,
the FPPC proposed that CIRM require its board members and high-level
employees to disclose investments in, and income from, entities that
are of the type with which CIRM would contract or from which CIRM
could procure goods or services as well as investments in, and income
from, biotech and pharmaceutical companies.  Because these
are the types of entities that are likely to create potential
conflicts of interest, we believe the disclosure categories are
appropriate.  It is important to remember, however, that
this is a preliminary proposal.  CIRM will seek input from
the Governance Subcommittee, the Board, and members of the public
before seeking approval of the amendments."

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

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

The $3 billion California stem cell agency, which is moving to engage the biotech industry ever more closely, is proposing a major weakening of the financial disclosure requirements for its board of directors and executives.

The move comes as the agency is also seeking to raise cash from the private sector to continue the state research effort's existence.  CIRM's dimming of transparency runs counter to government trends nationally for more disclosure rather than less, including regulations enacted last year by the NIH.

The proposed changes will be considered next Thursday by the CIRM directors' Governance Subcommittee, which will have public teleconference sites in San Francisco and Irvine and two each in Los Angeles and La Jolla.

Currently CIRM board members and top executives must disclose all their investments and income – in a general way – along with California real property that they hold. Under the changes, disclosures would instead be required only "if the business entity or source of income is of the type to receive grants or other monies from or through the California Institute for Regenerative Medicine." CIRM offered no explanation of what it means by "of the type to receive" funds from the agency.

The proposal further narrows disclosure in connection with income or investments in enterprises that provide facilities or services used by CIRM. With the removal of the requirement for reporting all investments, CIRM's changes also specified disclosure of income and investments connected to business entities (nonprofits are not mentioned) that are engaged in biomedical research or the manufacture of biomedical pharmaceuticals.

The new code would appear to give CIRM directors and executives wide personal latitude in determining what should be disclosed. The current language simply states that "all" investments, etc., must be disclosed. That language originated in the 1974 ballot initiative that created the state disclosure requirements. The initiative's intent was to give the public and interested parties access to key information that would allow them to determine what forces are at work in government and whether conflicts of interests exist – as opposed to simply trusting the assertions of officials without additional substantiation.

The new code also appears to relieve CIRM officials of reporting investment in or income from venture capital or other firms that may be engaged in financing biotech or stem cell enterprises, since the firms do not receive cash from CIRM or engage in biomedical research.

While the code appears to provide more reporting freedom for board members and executives, it also may indirectly impose a burden on them to determine whether any of their investments may involve biomedical research or enterprises that could possibly receive funds from CIRM at some point

Earlier this week, the California Stem Cell Report asked the stem cell agency about such issues. Kevin McCormack, CIRM's new senior director of public communications and patient advocate outreach, replied that the changes were "proposed" by the state Fair Political Practices Commission, which oversees state disclosure laws.

He said the FPPC says agencies "should tailor their disclosure categories to type of work performed by the agency."

McCormack cited as examples the State Board of Education and the state retirement system.

As for the specific changes in CIRM's code, McCormack said,

"Because these are the types of entities that are likely to create potential conflicts of interest, we believe the disclosure categories are appropriate."

McCormack did not comment on whether the proposed code would give board members more reporting latitude or whether it relieve them of reporting investments tied to the financing of biotech or stem cell firms. (The text of his response can be found here.)

The California Stem Cell Report is querying the FPPC concerning its policy regarding disclosure codes. CIRM's new code is expected to go before the the full CIRM board in late May. The changes are subject to review by the FPPC and then must formally go through the state administrative law process during which the public can comment and the code modified before final adoption.

Our take? The proposed changes are not in the best interests of CIRM or the people of California. The absence of transparency and disclosure only breeds suspicious speculation of the worst sort. The agency is already burdened by conflicts of interest that are built in by the ballot measure that created it in 2004. Nearly all of the $1.3 billion that CIRM has handed out has gone to institutions linked to CIRM directors. Weakening disclosure at a time when the biotech industry will become more closely tied to CIRM inevitably raises questions about financial linkages – present and future – between CIRM directors and executives and industry. For the past seven years, CIRM directors and staff have been able to comply with
more complete disclosure. They should continue to do so for the life of the agency, which will expire in less than a decade unless it finds additional sources of cash.

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

"In answer to your question, we
are proposing changes to the Conflict of Interest Code based upon
recommendations from the California Fair Political Practices
Commission (FPPC). The Political Reform Act requires state
agencies like CIRM to review their Conflict of Interest Codes every
two years.  The FPPC, which is charged with enforcing the
Political Reform Act, is responsible for reviewing and approving
CIRM's Conflict of Interest Code.  In preparation for this
review, CIRM's counsel met with the FPPC staff who suggested the
proposed amendments which are the subject of the upcoming Governance
Subcommittee meeting.  The proposed amendments to CIRM's
Conflict of Interest Code are consistent with the FPPC's position
that agencies should tailor their disclosure categories to type of
work performed by the agency.  For example, CalPERS's
conflict of interest code requires CalPERS officials to disclose
investments in, and income from, entities that are of the type with
which CalPERS contracts and entities in which funds administered by
CalPERS could be invested.  Likewise, the State Board of
Education requires its members to disclose investments, business
positions, and income from a publisher, manufacturer, or vendor of
instructional materials, or services offered to educational
institutions in the State of California and investments, positions of
management and income from any private school in the State of
California.  Similar to these codes, the FPPC proposed that
CIRM's Code be tailored to the nature of CIRM's work.  Thus,
the FPPC proposed that CIRM require its board members and high-level
employees to disclose investments in, and income from, entities that
are of the type with which CIRM would contract or from which CIRM
could procure goods or services as well as investments in, and income
from, biotech and pharmaceutical companies.  Because these
are the types of entities that are likely to create potential
conflicts of interest, we believe the disclosure categories are
appropriate.  It is important to remember, however, that
this is a preliminary proposal.  CIRM will seek input from
the Governance Subcommittee, the Board, and members of the public
before seeking approval of the amendments."

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

There could be a path to a simpler recovery after a heart attack. Duke University Medical Center scientists have discovered a way to turn the scar tissue that forms after cardiac arrest into healthy muscle tissue, which would make a stem cell transplant unnecessary.

To achieve this, researchers introduced microRNA to scar tissue cells in a living mouse. These hardened cells, called fibroblasts, develop as a result of a heart attack, and impede the organ's ability to pump blood. The microRNAs, which are molecules that govern the activity of several genes, were able to manipulate the fibroblasts to transform into cells that looked like cardiomyocytes, which comprise heart muscle.

The results of their study have been published in the journal Circulation Research. While further exploration is required, the find is promising for the millions of people in the U.S. that suffer from heart disease, the leading cause of death in this country. But it has application beyond that. If it works for the heart, theoretically it would help regenerate tissues in the brain, the kidneys, and other organs.

Now that this cell reversal technique has proven successful, researchers plan to test it with larger animals. If it works, they'll try it in humans, and hopefully have a practical application developed within the decade. [Science Dailyvia Reddit]

See the original post:
Scientists Have Found a Way to Regenerate Muscle Tissue After a Heart Attack [Medicine]

Public release date: 24-Apr-2012 [ | E-mail | Share ]

Contact: Dr Boris Kovacic Boris.Kovacic@vetmeduni.ac.at 43-125-077-5622 University of Veterinary Medicine -- Vienna

Although people generally talk about "cancer", it is clear that the disease occurs in a bewildering variety of forms. Even single groups of cancers, such as those of the white blood cells, may show widely differing properties. How do the various cancers arise and what factors determine their progression? Clues to these two issues, at least for leukaemias, have now been provided by Boris Kovacic and colleagues at the University of Veterinary Medicine, Vienna (Vetmeduni Vienna). The results are published in the current issue of the journal EMBO Molecular Medicine and have extremely important consequences for the treatment of a particularly aggressive type of leukaemia.

It is well known that many types of cancer arise as a result of a mutation within a cell and prevailing wisdom has held that the stage of differentiation of this cell determines exactly what form of cancer develops. For example, it was believed that so-called chronic myeloid leukaemia or CML arises from bone marrow stem cells, while a different type of leukaemia, known as B-cell acute lymphoid leukaemia or B-ALL, results from B-cell precursors. This belief has been spectacularly refuted by the latest results from Boris Kovacic and colleagues in the Vetmeduni Vienna's institutes of Animal Breeding and Genetics and of Pharmacology and Toxicology.

The researchers have now shown that both CML and B-ALL arise from the most primordial kind of blood cell (long-term haematopoietic stem cells), although the pathways by which the diseases progress are different. The usual causes of CML and B-ALL are two highly related versions of the same oncogene, BCR/ABL. If the primordial blood cells are transformed or made potentially cancerous by a particular version of BCR/ABL, for technical reasons termed BCR/ABLp210, the result is chronic myeloid leukaemia or CML. The long-term haematopoietic stem cells remain and act as the dreaded cancer stem cells, or CSCs, which ensure that the disease persists. Curing chronic myeloid leukaemia requires the complete elimination of the CSCs. However, if the long-term haematopoietic stem cells are transformed by a related version of BCR/ABL, BCR/ABLp185, the result is a highly aggressive form of leukaemia, B-ALL. The finding that B-ALL actually originates from the same stem cells as CML was both unexpected and highly provocative.

Kovacic and colleagues have shown further that B-ALL only develops if the transformed stem cell is exposed to a particular growth factor, interleukin-7. If interleukin-7 is present (it usually is), the transformed long-term haematopoietic stem cells undergo a differentiation step to CSCs, which in this case correspond to pro-B cells. If interleukin-7 is absent during the initial phase of transformation, B-ALL cannot develop.

In other words, two distinct types of cell are involved in leukaemia development, the primordial cells (also termed the cells of origin of cancer) and the cancer stem cells that cause the disease to progress. Unless the CSCs are eliminated, fresh cancer cells can arise at any time and the leukaemia will recur. The problem is that current leukaemia therapies are not designed to target CSCs. The primordial CSCs in CML are highly quiescent and thus difficult to target. In contrast, the CSCs in B-ALL are abundant and have a high turnover rate, which makes them susceptible to treatment. Treatment of B-ALL may thus succeed in eliminating most CSCs but if even a single cell remains intact it is likely that the patient will relapse, possibly with an even more aggressive form of leukaemia. "A therapy that targets the bulk of tumour cells will not work," as Kovacic succinctly summarizes his results. "To treat B-ALL successfully it will be necessary for us to learn much more about the development of the disease. A combined therapy is required, so future work should aim at developing drugs that target the long-term haematopoietic stem cells from which B-ALL is derived."

###

The paper "Diverging fates of cells of origin in acute and chronic leukemia" by Boris Kovacic, Andrea Hoelbl, Gabriele Litos, Memetcan Alacakaptan, Christian Schuster, Katrin M. Fischhuber, Marc A. Kerenyi, Gabriele Stengl, Richard Moriggl, Veronika Sexl and the late Hartmut Beug is published in the current issue of the journal "EMBO Molecular Medicine" (2012, Vol. 4 pp. 283-297).

The work was initiated at the Research Institute of Molecular Pathology (IMP) and was performed together with groups at the Medical University of Vienna and the Ludwig Boltzmann Institute for Cancer Research in Vienna.

Read more here:
Leukaemia cells have a remembrance of things past

A previously hairless mouse following an implantation of bioengineered hair follicles recreated from adult tissue-derived stem cells

Researchers lead by Professor Takashi Tsuji from the Tokyo University of Science have successfully induced the natural hair growth and loss cycle in previously hairless mice. They have achieved this feat through the implantation of bioengineered hair follicles recreated from adult-tissue derived stem cells. While these results offer new hope for curing baldness, the work has broader implications, demonstrating the potential of using adult somatic stem cells for the bioengineering of organs for regenerative therapies.

The method devised by Professor Tsujis team involves reconstructing hair follicle germs from adult epithelial stem cells and cultured dermal papilla cells (dermal papilla are nipple-like projections at the base of hairs) and implanting these germs within or between skin layers. To recreate the desired hair densities normally about 120 hair shafts per square centimeter (0.15 square inch) or 60-100 hair shafts per square centimeter following a conventional hair transplantation method 28 bioengineered follicle germs were transplanted onto a circular patch of cervical skin measuring 1 cm (0.39 in) in diameter. The resulting hair density of 124 hair shafts per square centimeter (plus or minus 17 shafts) turned out to be satisfactory, but there was more good news.

Far more importantly, the implanted follicle germs developed all the proper structures and formed correct connections with the surrounding host tissues, including epidermis, arrector pili muscle and nerve fibers. Also, the stem and progenitor cells along with their niches were recreated in the bioengineered follicles, making a continuous hair-growth cycle possible.

The method has been shown to work with all types of hair follicles, regardless of function, structure and color (depending on the type of the origin follicle). In fact, some features of the hair shaft, such as pigmentation, may be controlled fancy a new permanent hair color?

Although more research is still necessary (such as further study of stem cell niches and optimizing the way origin follicles are to be sourced for clinical applications), the study constitutes another milestone on the way to next generation regenerative therapies.

Source: Tokyo University of Science

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Adult stem cells used to induce the natural hair growth cycle in hairless mice

A judicial technicality may decide the fate of NIH-funded human embryonic stem cell research.

By Sabrina Richards | April 24, 2012

Wikimedia Commons, Avjoska

The legality of federally funding human embryonic stem cell (hESC) research is being questioned in court again, and the decision may rest on a technicality, reported ScienceInsider.

National Institutes of Health guidelines released in 2009 lifted the Bush-era restrictions on hESC research, but were met with a lawsuit by adult stem cell researchers that August. A preliminary injunction by the US District Court in Washington, DC, prevented NIH funding for hESCs in August 2010. Just 2 weeks later, the US Court of Appeals for the District Court stayed the injunction, then overturned it for good in April 20113 months before the appeals court dismissed the lawsuit altogether. Now, the case is once again in appeals court, and current arguments focus on whether this earlier decision is binding.

The plaintiffs argue that the 2009 NIH guidelines contravene the 1996 Dickey-Wicker Amendment, which prohibits federal funding for research that may harm or destroy human embryos. NIH argues that the earlier decision should be binding because the plaintiffs are not presenting new arguments, but the plaintiffs counter that the court has yet to rule on whether the NIH guidelines create demand for new hESC lines, which are derived from embryos.

The plaintiffs also argue that comments from opponents of hESC research should have been considered by the NIH when the guidelines were crafted, but the NIH disputes this, saying that the agency was responding to an order from President Obama asking how, not whether, to fund such research.

The Appeals Court may rule within 4 to 6 months, but some observers expect the case to eventually reach the US Supreme Court.

By Jef Akst

Science adviser John Holdren speaks out about how the Obama Administration is handling the controversial research that rendered avian flu transmissible between ferrets.

Original post:
Embryonic Stem Cells in Court Again

Public release date: 25-Apr-2012 [ | E-mail | Share ]

Contact: Kim Irwin kirwin@mednet.ucla.edu 310-206-2805 University of California - Los Angeles Health Sciences

Can one feel too attached? Does one need to let go to mature? Neural stem cells have this problem, too.

As immature cells, neural stem cells must stick together in a protected environment called a niche in order to divide so they can make all of the cells that populate the nervous system. But when it's time to mature, or differentiate, the neural stem cells must stop dividing, detach from their neighbors and migrate to where they are needed to form the circuits necessary for humans to think, feel and interact with the world.

Now, stem cell researchers at UCLA have identified new components of the genetic pathway that controls the adhesive properties and proliferation of neural stem cells and the formation of neurons in early development.

The finding by scientists at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA could be important because errors in this pathway can lead to a variety of birth defects that affect the structure of the nervous system, as well as more subtle changes that impair cognitive and motor functions associated with disorders such as autism.

The results of the four-year study are published April 26, 2012 in the peer-reviewed journal Neuron.

The UCLA team found that a delicate balance of gene expression enables the pool of neural stem and progenitor cells in early development to initially increase and then quickly stop dividing to form neurons at defined times.

"One of the greatest mysteries in developmental biology is what constitutes the switch between stem cell proliferation and differentiation. In our studies of the formation of motor neurons, the cells that are essential for movement, we were able to uncover what controls the early expansion of neural stem and progenitor cells, and more importantly what stops their proliferation when there are enough precursors built up," said Bennett G. Novitch, an assistant professor of neurobiology, a Broad Stem Cell Research Center scientist and senior author of the study. "If the neurons don't form at the proper time, it could lead to deficits in their numbers and to catastrophic, potentially fatal neurological defects."

During the first trimester of development, the neural stem and progenitor cells form a niche, or safe zone, within the nervous system. The neural stem and precursor cells adhere to each other in a way that allows them to expand their numbers and keep from differentiating. A protein called N-cadherin facilitates this adhesion, Novitch said.

See the article here:
Growing up as a neural stem cell: The importance of clinging together and then letting go