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Parcell Laboratories Honored as 2012 SBANE Innovation Award Winner

May 14th, 2012 10:12 pm

NEWTON, Mass., May 14, 2012 /PRNewswire/ --Parcell Laboratories, a leading adult stem cell company based in Newton, MA, was awarded the prestigious 2012 Innovation Award by the Smaller Business Association of New England (SBANE). Parcell joins the select list of winning companies from the last 26 years whose innovations have delivered proven value to customers.

SBANE uses its highly competitive Innovation Awards program to showcase technology driven enterprises that are potentially "game changers" in their markets. Parcell's ELA stem cell technology is a platform technology that has unlimited applications for tissue regeneration and is positioned to change the face of regenerative medicine. "We are honored to have been recognized by SBANE for our accomplishments and to be included among the roster of extremely successful companies that have been previous winners of the award," said Pamela Layton, the CEO of Parcell Laboratories. "The award is a testament to the dedication and tenacity of our terrific team." Past award winners include some of the most recognizable names in New England business, including Staples, Genzyme, Ben & Jerry's and Nantucket Nectars.

Parcell Laboratories holds the license and intellectual property to the ELA stem cell, which is considered to be the earliest lineage adult stem cell in the adult body. The cell is able to differentiate into all tissues and has the added benefit of being immune privileged, allowing it to be implanted without the risk of rejection. Parcell's ELA cells are being used by surgeons nationwide to enhance bone regeneration in the aging spine. The product is marketed under the name of PureGen Osteoprogenitor Cell Allograft by Alphatec Spine of Carlsbad, CA. Parcell is also in the development phase of therapeutics using the ELA stem cell for disc and cartilage repair.

Press Contact Susan Kinslow Kinslow@parcelllabs.com +617-928-9803

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Parcell Laboratories Honored as 2012 SBANE Innovation Award Winner

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VistaGen CEO Issues Update Letter to Stockholders

May 14th, 2012 10:12 pm

SOUTH SAN FRANCISCO, CA--(Marketwire -05/14/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA) (VSTA.OB), a biotechnology company applying stem cell technology for drug rescue, today issued the following letter to its stockholders and the investment community from its CEO, Shawn Singh.

To our valued Stockholders:

Since becoming a public company one year ago, we have progressed to perhaps the most exciting time in our company's 14-year history. To arrive at this point, more than $45 million, obtained through various strategic collaborations, investments and grant awards, has been carefully employed. We believe our pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, combined with the network of strategic relationships we have announced, will allow us to secure additional capital and the large market drug rescue opportunities that can deliver value to our stockholders.

Since the beginning of the year, our team has carefully reviewed our Top 10 drug rescue opportunities and narrowed our focus to our Top 5 candidates. Now we intend to launch our initial drug rescue program and secure strategic capital necessary to support it, as well as launch our second drug rescue program by year-end. We also are working on validation of LiverSafe 3D, our bioassay system for drug rescue involving liver toxicity and drug metabolism issues, for launch during the first half of next year.

The pharmaceutical industry continues to face extremely high barriers in bringing new medicine to market. The number of drugs approved by the FDA over the past decade has dropped precipitously, by over 50%, in spite of staggering increases in resources devoted to R&D by pharmaceutical companies. Based on the progress we have made with CardioSafe 3D and our efforts to build our strategic drug rescue ecosystem of collaborators, we believe our core business model -- to use our stem cell technology and strategic relationships to develop less toxic variants of drugs that have already been proven in vitro to be effective -- is now more commercially promising than at any other point in our history. We believe we will be able to help major pharmaceutical companies avoid the loss of years of time and millions of dollars spent in developing new therapies that have positive efficacy data, but must be discontinued due to later discovery of unsafe toxicity levels for human heart and liver tissue.

Over the past year, we have secured additional intellectual property protection and entered into strategic relationships with leading biotech firms and academic researchers to support development of our stem technology and our drug rescue-based commercialization initiatives:

Over the next 12 months, we have an ambitious agenda to work closely with our advisors and collaborators to secure capital and achieve these transformative milestones:

Our goals are reachable, with strategic financing. We believe we have the right technology, intellectual property, development teams and specialized focus to deliver on our founding mission -- "putting humans first" -- bringing clinically relevant human biology to the front end of the drug development process, long before standard animal and human testing, and using better cells to make better medicine.

We would like to thank our partners, advisors, employees and each of you, our loyal stockholders, for helping support us in our efforts to deliver long-term value for you.

Sincerely,

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VistaGen CEO Issues Update Letter to Stockholders

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Regenerative Sciences Receives $2M Investment for Orthopedic Stem Cell Initiatives

May 14th, 2012 10:12 pm

DENVER, May 14, 2012 /PRNewswire/ -- Regenerative Sciences, Inc., a company dedicated to advancing orthopedic care through non-surgical adult stem cell procedures, today announced that it has secured a $2M investment from philanthropist, visionary and businessman John C. Malone, PhD, chairman of Liberty Media Corporation. In addition to advancing Regenerative Sciences' clinical and lab-based stem cell research, the investment will help support the national expansion of their Regenexx Physician Network.

Regenerative Sciences' Regenexx procedures utilize a patient's own stem cells to help repair a broad range of common injuries and degenerative conditions, including cartilage lesions, torn ligaments and tendons, osteoarthritis and bulging spinal discs. For many, the procedures offer a viable alternative to arthroscopic surgery, open-joint surgery, or joint replacement surgery. Regenexx patients experience little or no downtime from the procedures and avoid the lengthy rehabilitation period associated with most surgical procedures.

"We are proud of our accomplishments in the field of regenerative interventional orthopedics and it's exciting that our work has drawn the attention of such a noted entrepreneur and philanthropist," said Christopher J. Centeno, M.D., Chief Executive Officer of Regenerative Sciences. "Dr. Malone shares our vision for forging the next generation of minimally invasive regenerative treatments. This investment will not only bolster our existing stem cell research programs and make our procedures available in all regions of the U.S., but it will help us maintain a leadership role in clarifying the regulatory space for physician stem cell use."

Regenerative Sciences is at the forefront of regenerative orthopedic medicine within the United States and the company is bringing the future of orthopedic treatments to patient care today.

About Regenerative Sciences

Regenerative Sciences is an outgrowth of the Centeno-Schultz clinic, where we are reinventing orthopedic care for the 21st century using key biologics such as stem cells, next generation tools and devices, and unique therapeutic approaches. Our signature initiative, Interventional Orthopedics, allows doctors to treat orthopedic conditions through injection, rather than traditional invasive surgery. The Regenexx Physician Network brings together like-minded physicians from around the country to offer more patients access to our innovative procedures. For more information on Regenerative Sciences and Regenexx procedures, visit: http://www.regenexx.com

About John C. Malone, PhD

Dr. John C. Malone holds a bachelor's degree in electrical engineering and economics from Yale University, where he was a Phi Beta Kappa and merit scholar. He also holds a master's degree in industrial management and a Ph.D. in operations research from Johns Hopkins University.

Dr. Malone is Chairman of Liberty Media Corporation, a position he has held since 1990. Dr. Malone is also the Chairman of the Board of Liberty Global, Inc. (LGI), a position he has held since June, 2005. From 1996 to March 1999 when Tele-Communications, Inc. (TCI) merged with AT&T Corp., he was also Chairman and Chief Executive Officer of TCI. Previous to that, from 1973 to 1996, Dr. Malone served as President and CEO of TCI. He currently serves on the Board of Directors for CATO Institute, Expedia, Inc., Discovery Communications, Inc., and SiriusXM.

Contact:

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Regenerative Sciences Receives $2M Investment for Orthopedic Stem Cell Initiatives

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Research and Markets: Stem Cell Research Products: Opportunities, Tools & Technologies 2012 (Updated)

May 14th, 2012 10:12 pm

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/lffnp7/stem_cell_research) has announced the addition of the "Stem Cell Research Products: Opportunities, Tools & Technologies 2012 (Updated)" report to their offering.

Stem cells are primitive cells found in all multi-cellular organisms that are characterized by self-renewal and the capacity to differentiate into any mature cell type. Several broad categories of stem cells exist, including embryonic stem cells, derived from blastocysts; fetal stem cells, obtained from aborted fetuses; adult stem cells, found in adult tissues; cord blood stem cells, isolated from umbilical tissue; dental stem cells, derived from deciduous teeth; cancer stem cells, which give rise to clonal populations of cells that form tumors or disperse in the body; and animal stem cells, derived from non-human sources.

In a developing embryo, stem cells can differentiate into all of the specialized embryonic tissues. In adult organisms, stem and progenitor cells act as a repair system for the body, replenishing specialized cells. Of interest to researchers is the potential for use of stem cells in regenerative medicine to treat conditions ranging from diabetes, to cardiovascular disease and neurological disorders. Additionally, the ability to use stem cells to improve drug target validation and toxicology screening is of intense interest to pharmaceutical companies. Stem cells are also being studied for their ability to improve both the understanding and treatment of birth disorders.

To facilitate research resulting from interest in these far-ranging applications, a large and growing stem cells research products market has emerged. Large companies selling stem cell research products include Life Technologies, BD Biosciences, Thermo Fisher Scientific, and Millipore, although dozens of other suppliers exist as well. Products offered by these companies include: antibodies to stem cell antigens, bead-based stem cell separation systems, stem cell protein purification and analysis tools, tools for DNA and RNA-based characterization of stem cells, stem cell culture and media reagents, stem cell specific growth factors and cytokines, tools for stem cell gene regulation, a range of stem cell services, tools for in vivo and in vitro stem cell tracking, and stem cell lines.

This report explores current market conditions and provides guidance for companies interested in developing strategically positioned stem cell product lines.

Featured elements of this report include:

- What are novel stem cells research products that can be developed?

- What stem cells types are most frequently used by research scientists?

- Which species of stem cells do scientists prefer and what are the factors driving this preference (access, pricing, funding, handling advantages)?

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Research and Markets: Stem Cell Research Products: Opportunities, Tools & Technologies 2012 (Updated)

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Xenetic Biosciences – Appointment of VP for Drug Development

May 14th, 2012 11:13 am

14 May 2012

Xenetic Biosciences plc

('Xenetic' or 'the Company')

Appointment of Vice President for Drug Development

Xenetic Biosciences plc (LSE: XEN.L), a bio-pharmaceutical company specialising in the development of high-value differentiated biological and vaccines and novel cancer drugs, announces that Dr Henry Hoppe IV has been appointed as Vice President of Drug Development for the Company.

Dr Hoppe is a leading biotechnology drug development executive with over 20 years' experience in recombinant protein, monoclonal antibody and stem cell expression for clinical therapies. His is a key appointment for Xenetic that is a pivotal step in establishing the Company's new Drug Development Centre in Boston. Dr Hoppe's principal expertise lies in the processes surrounding regulatory submissions, IND filings and clinical trials, especially in the orphan and rare disease arena, exemplified in his 17 years at Genzyme Corporation (NasdaqGS: GENZ - news) where he was instrumental in the development and launch of many of their leading products.

About Dr Hoppe

Dr Hoppe is a biotechnology process development executive with over 20 years experience in recombinant protein, monoclonal antibody and stem cell expression for clinical therapies. He has written and reviewed IND/NDA CMC sections for numerous recombinant protein and gene therapy programs, including those for Cerezyme, Fabrazyme, Myozyme and Thyrogen, being four currently marketed products of the Genzyme Corporation. He has amassed more than 20 years experience with all aspects of therapeutic development from the bench through Phase II clinical trials including managing Clinical Manufacturing Organisations (CMOs) in both the United States and Europe (Chicago Options: ^REURUSD - news) .

Dr Hoppe graduated with a Ph.D. in Genetic Toxicology from the Massachusetts Institute of Technology (MIT) in 1980 having first gained his Bachelors degree at MIT in 1973. Between 1980 and 1984, Dr Hoppe held positions at the Harvard Medical School and the University Hospital of Boston.

From 1984 to 2001, Dr Hoppe worked for Genzyme Corporation focussing on therapies for rare genetic diseases. He was subsequently appointed Vice President of Therapeutic Development for ViaCell Inc. where he delivered stem cells to clinical trials and designed Phase II manufacturing processes.

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Xenetic Biosciences - Appointment of VP for Drug Development

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Joseph Estrada defies age, shares how he did it: Stem cell therapy

May 14th, 2012 11:11 am

By Cathy C. Yamsuan Philippine Daily Inquirer

Former President Joseph Erap Estrada had always maintained that giving generously to friends and forgiving opponents are the secrets to staying young.

But time has a way of catching up with even the most formidable leading men.

Since he entered national politics 25 years ago, Estrada has struggled with the attributes of old ageweight gain, a painful knee here, a cataract there.

He needed some kind of elixir of youth to put to right what nature has put asunder. And to get back on his feet in time to serve the people, he said which has no age limit.

So he did it, and is very open about it. What is it?

At the prodding of friends, the 75-year-old Estrada flew to Frankfurt, Germany, last month to undergo fresh cell therapy (also known as stem cell treatment), an innovative albeit controversial procedure where fresh cells from donor animals are injected into the human body to treat diseases or reverse the aging process.

Fresh cell therapy operates under the principle of like heals like.

The fresh cells from a donor animals organ are infused into the human counterpart.

Substances in the donors blood are supposed to reactivate the human bodys immune system and defense mechanism, a reaction that would eventually rebuild and revitalize aging tissues.

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Joseph Estrada defies age, shares how he did it: Stem cell therapy

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In The Know: Stem cell therapy

May 14th, 2012 11:11 am

Philippine Daily Inquirer

Former President and current Pampanga Rep. Gloria Macapagal-Arroyo, who was suffering from a mineral deficiency in her bones arising from two corrective surgeries last September, wanted to seek alternative stem cell therapy abroad.

However, she was barred from leaving the country last November after Justice Secretary Leila de Lima refused to honor the temporary restraining order issued by the high court on the inclusion of Arroyo and her husband Jose Miguel Mike Arroyo in the immigration bureaus watch list.

In the wake of Arroyos supposed plan to try the radical technology at stem cell centers abroad to cure what her doctors here described as a rare bone disease, a province mate and a colleague of the former President filed a bill to put up a stem cell center in the country.

Pampanga Rep. Carmelo F. Lazatin, a member of the minority bloc in Congress, has filed House Bill No. 5287 mandating the establishment of a research facility to explore the benefits of stem cell technology as a potential cure for incurable diseases.

Blank cells

Stem cells, the foundation of every organ, tissue and cell within the human body, are like blank cells that do not yet have a specific physiological function, according to Harvard Stem Cell Institute (HSCI).

But when proper conditions in the body or in the laboratory occur, stem cells develop into specialized tissues and organs, HSCI explains in its website, adding that there are two sources of stem cells used in research: the adult stem cells and embryonic stem cells.

Adult stem cells are found in differentiated tissues and organs throughout the body while embryonic stem cells are obtained from the inner cell mass of a blastocyst, the ball of cells formed when the fertilized egg or zygote divides and forms two cells, then again to form four and so on, HSCI said.

In 2008, the Vatican issued a sweeping document on bioethical issues titled Dignitas Personae or The Dignity of the Person, taking into account recent developments in biomedical technology and reinforcing the Churchs opposition to embryonic stem cell research, in vitro fertilization, human cloning and genetic testing on embryos before implantation.

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In The Know: Stem cell therapy

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New Heart Valve Repair System Tested for Safety

May 13th, 2012 4:00 pm
(HealthDay News) --
A new method of repairing leaking mitral heart valves appears safe, a small
study shows.

In the new study, researchers tested a reversible implant called the
Percutaneous Transvenous Mitral Annuloplasty (PTMA) system, which is installed
via a catheter.

In the heart, the mitral valve controls the flow of blood from the left atrium
into the left ventricle (from the upper left chamber into the lower left
chamber). A leaking mitral valve causes blood to flow back into the left
atrium. This condition can worsen existing heart failure or cause congestive
heart failure, according to a news release from the American Heart Association.

Currently, mitral valve repair requires opening the chest and putting the patient
on a heart-lung machine. This method increases the risk of heart attack and
stroke during surgery, as well as post-surgery risks such as lung problems,
irregular heartbeat and infection, the news release noted. Read more…

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

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StemCells, Inc., Hoping for as Much as $40 Million from California Stem Cell Agency

May 13th, 2012 3:59 pm


StemCells, Inc., said today it has
applied for as much as $40 million in funding from the California
stem cell agency for two projects dealing with Alzheimer's disease
and cervical spinal cord injury.
The announcement came in a news release
dealing with the publicly traded firm's quarterly earnings. The applications are part of a $240 million round expected to be acted on in late July by the board
of the $3 billion California stem cell agency. Funding for
businesses in the disease team round is expected to come through a
loan.
StemCells, Inc., of Newark, Ca., said,

"In January 2012, we submitted two
applications to the California Institute of Regenerative Medicine
(CIRM)
for 'Disease Team Therapy Development Research Awards,' one
for Alzheimer's disease and one for cervical spinal cord injury. A
research award may be up to $20 million, payable over four years, to
fund preclinical and IND-enabling activities with the aim of starting
human clinical trials within a four-year window."

Applications in the round were reviewed
behind closed doors in April. CIRM also has a policy of not releasing the
names of applicants until its board acts and then only if an
applicant is approved. CIRM says it does not want to embarrass firms
that do not win approval. That includes individual researcher names
as well as the names of such institutions as the University of
California
.
During discussion of grant applications by the CIRM board, directors are not told the names of the applicants,
just the number of the application. If board members have conflicts
of interest on specific applications, they are barred from voting on
and discussing the application. The names of applicants have
occassionally slipped out. Sometimes their identities can also be
discerned by information contained in the summaries of the reviews of
the applications, which become available on the CIRM web site shortly before the directors act. The summaries normally carry scientific scores and recommendations for funding.
Most companies seeking funding from
CIRM do not identify themselves in advance, although they do if they
appeal a negative decision by reviewers. The board has ultimate
authority for approval of grants but has almost never rejected a
recommendation for funding by reviewers.
StemCells Inc. was founded by Irv Weissman of Stanford, who sits on its board of directors. Weissman is also on its scientific advisory board along with Fred Gage
of Salk and David Anderson of Caltech. Weissman and Gage have won
substantial grants from CIRM. 
StemCells Inc.'s stock price closed at
92 cents yesterday. Its 52-week high was $8.20, and its 52 week low
was 70 cents.
Here is a link to an analyst's report
on the company.

(Editor's note: An earlier version of this item incorrectly stated that the disease team round will be acted on later this month.)

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

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Biotech Biz Alert: California Stem Cell Agency Altering Loan Policies

May 13th, 2012 3:59 pm


The California stem cell agency is in
the midst of making significant changes in its lending regulations,
but says it is not part of an effort to transfer a $25 million loan
to Geron to another company.
That does not mean, however, that the agency is not going to
transfer the loan at some point. CIRM says it already has the
authority to do so.
Talk has surfaced from time to time at
CIRM meetings about the likelihood of helping to continue with the
hESC clinical trial that Geron abruptly abandoned last fall. The
surprise termination of Geron's hESC program came only a few months
after CIRM and Geron signed a $25 million loan agreement in August.
Geron is trying to sell off its hESC business, although Geron's hESC
team has already left the company, according to industry reports.
Modification of the CIRM loan
regulations has been underway for some time. Tomorrow the CIRM
directors' Intellectual Property and Industry Subcommittee will consider the latest proposals.
Some of the changes deal with
relinquishment and transfer of loans. The modifications explicitly
give CIRM President Alan Trounson the ability to transfer a loan
without having to go through additional reviews or seek board
approval. Other changes are also designed to clarify and remove
ambiguities in the transfer arrangement, which may well be necessary
in order to make a transfer acceptable to a buyer of the Geron
assets.
Geron paid off the loan last fall but
it is not clear whether that action would preclude a transfer. At one
point earlier this year, Trounson said he was involved in helping to find a buyer, but it is not clear whether any CIRM official is
currently involved. Geron has hired  Stifel
Nicolaus & Co
.
to help peddle
the hESC business.
CIRM's loan changes are complex. The
agency has not yet put together in one place a straightforward
rationale and explanation of all the modifications. Nonetheless,
biotech and stem cell firms should pay close attention to the
proposals. They could mean the difference between the infusion or
loss of millions for a company's research.
The proposals are expected to go before
the full CIRM board later this month. Then they will be subject to
the state's administrative law process, including a period for public
comment.
Tomorrow's meeting has public
teleconference locations in San Francisco, Los Angeles, La Jolla and
two in Irvine. Specific addresses can be found on the agenda.

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

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Advisor to CIRM Nominated to Board of CIRM Grant Recipient Expecting $5 Million from Agency

May 13th, 2012 3:59 pm


A "special
advisor" to the $3 billion California stem cell agency has been nominated to the board of directors of Sangamo BioSciences, Inc., a
firm that is sharing in a $14.5 million grant from the state research
enterprise.
She is Saira Ramasastry, managing partner of Life Sciences Advisory, LLC, of
Emerald Lake Hills, Ca., and who also has worked as a consultant to
Sangamo. Ramasastry's ties to CIRM go back to at least May of 2010,
when she served as a consultant for the panel that CIRM hired to
review its operations. The panel strongly recommended that CIRM
engage industry more warmly. Since then Ramasastry's contracts with
CIRM have totalled $65,000. Her current $25,000 contract describes
her work for CIRM as "industry analysis and consultation."
Ramasastry's
website says she serves as "a special advisor to CIRM in
industry engagement initiatives and strategic projects." Her
firm also offers expertise to life sciences firms in "strategic
alternatives advisory, strategic options analysis, tailored business
development solutions and innovative financing strategies."
In a news release April 30 announcing her nomination, Sangamo said Ramasastry has worked as a consultant to the Richmond, Ca., company. William Ringo, chairman of Sangamo's board of
directors, said,

 "Saira's
extensive experience in global healthcare investment banking and
strategic advisory consulting will bring valuable financial,
commercial assessment and business development skills to our board."

Compensation for Sangamo directors in 2011 ranged from $75,000 to $35,000 for those who served a full year plus stock options. 

Sangamo is sharing
in a $14.5 million, four-year grant from CIRM with the City of Hope
in Los Angeles dealing with an AIDS- related lymphoma therapy. The
grant was approved in 2009. Sangamo expects to receive $5.2 million from the grant if it runs for the full four years. As of the end of 2011, the firm has received $2.4 million, according to its financial documents. In March, Ellen Feigal, CIRM senior vice
president for research and development, said the effort is due for an
evaluation late this year.  Earlier this year, CIRM terminated one $19 million grant in the same round after it failed to meet milestones.

Sangamo's board is
scheduled to vote on Ramasastry's nomination on June 21. 
The California
Stem Cell Report
has asked Ramasastry if she has any comment for
publication. We are also querying CIRM and Sangamo. Their comments
will be carried verbatim when we receive them.
Our take?
Ramasastry's consulting work with both CIRM and Sangamo demonstrates
again the tiny size of the world of stem cell science. It also raises
questions about conflicts of interest involving CIRM and industry. Can
a consultant in such a position serve two masters and serve them both
equally well? CIRM's interests are not necessarily the same as
Sangamo's, which is a publicly traded firm working diligently to
generate profit and financial returns for its shareholders. To do
that, it needs capital from its financial "backers,"
including CIRM. The stem cell agency, however, is in the business of
getting the results that it wants from Sangamo. If not, the grant
can be cancelled. Working for both the stem cell agency, whose
paramount obligation is to the people of California, and a recipient
of the agency's millions is incompatible.

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

Read More...

New Heart Valve Repair System Tested for Safety

May 13th, 2012 3:57 pm
(HealthDay News) --
A new method of repairing leaking mitral heart valves appears safe, a small
study shows.

In the new study, researchers tested a reversible implant called the
Percutaneous Transvenous Mitral Annuloplasty (PTMA) system, which is installed
via a catheter.

In the heart, the mitral valve controls the flow of blood from the left atrium
into the left ventricle (from the upper left chamber into the lower left
chamber). A leaking mitral valve causes blood to flow back into the left
atrium. This condition can worsen existing heart failure or cause congestive
heart failure, according to a news release from the American Heart Association.

Currently, mitral valve repair requires opening the chest and putting the patient
on a heart-lung machine. This method increases the risk of heart attack and
stroke during surgery, as well as post-surgery risks such as lung problems,
irregular heartbeat and infection, the news release noted. Read more…

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

Read More...

StemCells, Inc., Hoping for as Much as $40 Million from California Stem Cell Agency

May 13th, 2012 3:57 pm


StemCells, Inc., said today it has
applied for as much as $40 million in funding from the California
stem cell agency for two projects dealing with Alzheimer's disease
and cervical spinal cord injury.
The announcement came in a news release
dealing with the publicly traded firm's quarterly earnings. The applications are part of a $240 million round expected to be acted on in late July by the board
of the $3 billion California stem cell agency. Funding for
businesses in the disease team round is expected to come through a
loan.
StemCells, Inc., of Newark, Ca., said,

"In January 2012, we submitted two
applications to the California Institute of Regenerative Medicine
(CIRM)
for 'Disease Team Therapy Development Research Awards,' one
for Alzheimer's disease and one for cervical spinal cord injury. A
research award may be up to $20 million, payable over four years, to
fund preclinical and IND-enabling activities with the aim of starting
human clinical trials within a four-year window."

Applications in the round were reviewed
behind closed doors in April. CIRM also has a policy of not releasing the
names of applicants until its board acts and then only if an
applicant is approved. CIRM says it does not want to embarrass firms
that do not win approval. That includes individual researcher names
as well as the names of such institutions as the University of
California
.
During discussion of grant applications by the CIRM board, directors are not told the names of the applicants,
just the number of the application. If board members have conflicts
of interest on specific applications, they are barred from voting on
and discussing the application. The names of applicants have
occassionally slipped out. Sometimes their identities can also be
discerned by information contained in the summaries of the reviews of
the applications, which become available on the CIRM web site shortly before the directors act. The summaries normally carry scientific scores and recommendations for funding.
Most companies seeking funding from
CIRM do not identify themselves in advance, although they do if they
appeal a negative decision by reviewers. The board has ultimate
authority for approval of grants but has almost never rejected a
recommendation for funding by reviewers.
StemCells Inc. was founded by Irv Weissman of Stanford, who sits on its board of directors. Weissman is also on its scientific advisory board along with Fred Gage
of Salk and David Anderson of Caltech. Weissman and Gage have won
substantial grants from CIRM. 
StemCells Inc.'s stock price closed at
92 cents yesterday. Its 52-week high was $8.20, and its 52 week low
was 70 cents.
Here is a link to an analyst's report
on the company.

(Editor's note: An earlier version of this item incorrectly stated that the disease team round will be acted on later this month.)

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

Read More...

Biotech Biz Alert: California Stem Cell Agency Altering Loan Policies

May 13th, 2012 3:57 pm


The California stem cell agency is in
the midst of making significant changes in its lending regulations,
but says it is not part of an effort to transfer a $25 million loan
to Geron to another company.
That does not mean, however, that the agency is not going to
transfer the loan at some point. CIRM says it already has the
authority to do so.
Talk has surfaced from time to time at
CIRM meetings about the likelihood of helping to continue with the
hESC clinical trial that Geron abruptly abandoned last fall. The
surprise termination of Geron's hESC program came only a few months
after CIRM and Geron signed a $25 million loan agreement in August.
Geron is trying to sell off its hESC business, although Geron's hESC
team has already left the company, according to industry reports.
Modification of the CIRM loan
regulations has been underway for some time. Tomorrow the CIRM
directors' Intellectual Property and Industry Subcommittee will consider the latest proposals.
Some of the changes deal with
relinquishment and transfer of loans. The modifications explicitly
give CIRM President Alan Trounson the ability to transfer a loan
without having to go through additional reviews or seek board
approval. Other changes are also designed to clarify and remove
ambiguities in the transfer arrangement, which may well be necessary
in order to make a transfer acceptable to a buyer of the Geron
assets.
Geron paid off the loan last fall but
it is not clear whether that action would preclude a transfer. At one
point earlier this year, Trounson said he was involved in helping to find a buyer, but it is not clear whether any CIRM official is
currently involved. Geron has hired  Stifel
Nicolaus & Co
.
to help peddle
the hESC business.
CIRM's loan changes are complex. The
agency has not yet put together in one place a straightforward
rationale and explanation of all the modifications. Nonetheless,
biotech and stem cell firms should pay close attention to the
proposals. They could mean the difference between the infusion or
loss of millions for a company's research.
The proposals are expected to go before
the full CIRM board later this month. Then they will be subject to
the state's administrative law process, including a period for public
comment.
Tomorrow's meeting has public
teleconference locations in San Francisco, Los Angeles, La Jolla and
two in Irvine. Specific addresses can be found on the agenda.

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

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Advisor to CIRM Nominated to Board of CIRM Grant Recipient Expecting $5 Million from Agency

May 13th, 2012 3:57 pm


A "special
advisor" to the $3 billion California stem cell agency has been nominated to the board of directors of Sangamo BioSciences, Inc., a
firm that is sharing in a $14.5 million grant from the state research
enterprise.
She is Saira Ramasastry, managing partner of Life Sciences Advisory, LLC, of
Emerald Lake Hills, Ca., and who also has worked as a consultant to
Sangamo. Ramasastry's ties to CIRM go back to at least May of 2010,
when she served as a consultant for the panel that CIRM hired to
review its operations. The panel strongly recommended that CIRM
engage industry more warmly. Since then Ramasastry's contracts with
CIRM have totalled $65,000. Her current $25,000 contract describes
her work for CIRM as "industry analysis and consultation."
Ramasastry's
website says she serves as "a special advisor to CIRM in
industry engagement initiatives and strategic projects." Her
firm also offers expertise to life sciences firms in "strategic
alternatives advisory, strategic options analysis, tailored business
development solutions and innovative financing strategies."
In a news release April 30 announcing her nomination, Sangamo said Ramasastry has worked as a consultant to the Richmond, Ca., company. William Ringo, chairman of Sangamo's board of
directors, said,

 "Saira's
extensive experience in global healthcare investment banking and
strategic advisory consulting will bring valuable financial,
commercial assessment and business development skills to our board."

Compensation for Sangamo directors in 2011 ranged from $75,000 to $35,000 for those who served a full year plus stock options. 

Sangamo is sharing
in a $14.5 million, four-year grant from CIRM with the City of Hope
in Los Angeles dealing with an AIDS- related lymphoma therapy. The
grant was approved in 2009. Sangamo expects to receive $5.2 million from the grant if it runs for the full four years. As of the end of 2011, the firm has received $2.4 million, according to its financial documents. In March, Ellen Feigal, CIRM senior vice
president for research and development, said the effort is due for an
evaluation late this year.  Earlier this year, CIRM terminated one $19 million grant in the same round after it failed to meet milestones.

Sangamo's board is
scheduled to vote on Ramasastry's nomination on June 21. 
The California
Stem Cell Report
has asked Ramasastry if she has any comment for
publication. We are also querying CIRM and Sangamo. Their comments
will be carried verbatim when we receive them.
Our take?
Ramasastry's consulting work with both CIRM and Sangamo demonstrates
again the tiny size of the world of stem cell science. It also raises
questions about conflicts of interest involving CIRM and industry. Can
a consultant in such a position serve two masters and serve them both
equally well? CIRM's interests are not necessarily the same as
Sangamo's, which is a publicly traded firm working diligently to
generate profit and financial returns for its shareholders. To do
that, it needs capital from its financial "backers,"
including CIRM. The stem cell agency, however, is in the business of
getting the results that it wants from Sangamo. If not, the grant
can be cancelled. Working for both the stem cell agency, whose
paramount obligation is to the people of California, and a recipient
of the agency's millions is incompatible.

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

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Stem Cell Therapy Exclusively at Gandy Animal Hospital – Tampa, FL – Video

May 13th, 2012 12:10 am

11-05-2012 14:16 Stem cells are the body's repair cells. They have the ability to divide and differentiate into many different types of cells based on where they are needed throughout the body. Stem cells can divide and turn into tissues such as skin, fat, muscle, bone, cartilage, and nerve to name a few. With this capability, we can use them as a treatment for joint injuries, ligament and tendon damage, and fractured bones. Using MediVet America's Stem Cell Therapy, we have seen positive clinical improvement in 95% of the arthritic cases performed nationwide. Some owners have even reported seeing a difference in as little as a week!

Continued here:
Stem Cell Therapy Exclusively at Gandy Animal Hospital - Tampa, FL - Video

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In The Know: Stem cell therapy

May 13th, 2012 12:10 am

Philippine Daily Inquirer

Former President and current Pampanga Rep. Gloria Macapagal-Arroyo, who was suffering from a mineral deficiency in her bones arising from two corrective surgeries last September, wanted to seek alternative stem cell therapy abroad.

However, she was barred from leaving the country last November after Justice Secretary Leila de Lima refused to honor the temporary restraining order issued by the high court on the inclusion of Arroyo and her husband Jose Miguel Mike Arroyo in the immigration bureaus watch list.

In the wake of Arroyos supposed plan to try the radical technology at stem cell centers abroad to cure what her doctors here described as a rare bone disease, a province mate and a colleague of the former President filed a bill to put up a stem cell center in the country.

Pampanga Rep. Carmelo F. Lazatin, a member of the minority bloc in Congress, has filed House Bill No. 5287 mandating the establishment of a research facility to explore the benefits of stem cell technology as a potential cure for incurable diseases.

Blank cells

Stem cells, the foundation of every organ, tissue and cell within the human body, are like blank cells that do not yet have a specific physiological function, according to Harvard Stem Cell Institute (HSCI).

But when proper conditions in the body or in the laboratory occur, stem cells develop into specialized tissues and organs, HSCI explains in its website, adding that there are two sources of stem cells used in research: the adult stem cells and embryonic stem cells.

Adult stem cells are found in differentiated tissues and organs throughout the body while embryonic stem cells are obtained from the inner cell mass of a blastocyst, the ball of cells formed when the fertilized egg or zygote divides and forms two cells, then again to form four and so on, HSCI said.

In 2008, the Vatican issued a sweeping document on bioethical issues titled Dignitas Personae or The Dignity of the Person, taking into account recent developments in biomedical technology and reinforcing the Churchs opposition to embryonic stem cell research, in vitro fertilization, human cloning and genetic testing on embryos before implantation.

Originally posted here:
In The Know: Stem cell therapy

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ALS Patients Approved For More Stem Cells

May 11th, 2012 8:14 am

University of Michigan Hospital (Credit: UM.edu)

ANN ARBOR Three patients with amyotrophic lateral sclerosis will be permitted to receive a second dose of stem cells delivered directly to the spinal cord, in a clinical trial being led by the University of Michigans Eva Feldman, M.D.

The U.S. Food and Drug Administration approved the second treatment after a review concluded that the patients showed no adverse effects from their first implantation surgeries.

All have ALS, the inevitably fatal degenerative disease of the nervous system that many call Lou Gehrigs disease. They received injections directly into the lumbar, or lower, area of the spinal cord.

None of the patients experienced any long-term complications related to either the surgical procedure or the implantation of stem cells, or showed signs of rejecting the cells. And in the months following the surgery to inject the cells, none showed evidence that their ALS progression was accelerating.

These patients will receive a second implantation to the cervical, or upper, region of the spine where the nerves that control breathing reside. Most ALS patients die of respiratory failure as these nerves die or are damaged by the disease.

We believe that the cells and the route of administration are safe, said Feldman, principal investigator of the trial and the director of the UMs A. Alfred Taubman Medical Research Institute. The FDA go-ahead to bring these three patients back for re-dosing is a further validation of that.

The trial is funded by Neuralstem, to which Feldman is an unpaid consultant.

This Phase 1 safety trial, which is taking place at Emory University in Atlanta, began in January 2010. After reviewing safety data from the first 12 patients, the FDA granted approval for the trial to advance the cervical injections. Three patients so far have received injections to that area. Those to be re-dosed will come from the first cohort of 12.

Results from that cohort recently were featured in the peer-reviewed journal Stem Cells in an article authored by Feldman and her colleagues at Emory, including neurologist Jonathan Glass, M.D. and neurosurgeon Nick Boulis, M.D., who performed the implantation surgeries. Boulis, an adjunct professor at UMs Medical School and a Taubman Scholar, also developed the device used to inject the stem cells into the spinal cord, which received a notice of patent allowance from U.S. Patent and Trademark Office in October.

Continued here:
ALS Patients Approved For More Stem Cells

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International Stem Cell Corporation Announces New Stem Cell Manufacturing Technologies to Support its Therapeutic …

May 11th, 2012 8:14 am

CARLSBAD, Calif.--(BUSINESS WIRE)--

International Stem Cell Corporation (OTCBB: ISCO.OB - News) http://www.internationalstemcell.com today announced that the Company has developed new technologies to commercialize the use of human parthenogenetic stem cells (hpSC) to treat human diseases. The methods announced today are capable of producing populations of stem cells and their therapeutically valuable derivatives not only to a higher level of purity but also at a cost that is approximately several times lower than previously reported techniques.

ISCOs research team has developed a new method to derive high-purity populations of neural stem cells (NSC) from hpSC and further differentiate them into dopaminergic neurons. This method is capable of generating sufficient quantities of neuronal cells for ISCOs pre-clinical and clinical studies and is highly efficient as it requires substantially less time and labor in addition to using fewer costly materials than traditional methods. ISCOs technologies make possible the creation of billions of neuronal cells necessary for conducting such studies from a small batch of stem cells.

ISCO has also announced today that it has developed a new high-throughput cell culture method for growing human parthenogenetic stem cells (hpSC) in large quantities. This new technique is easily scalable and can produce the quantities of cGMP grade hpSC necessary for commercial and therapeutic applications.

One of the most challenging issues in commercializing stem cell based treatments is creating high-purity populations of stem cell derivatives at a reasonable cost. I believe the new methods we have developed solve this important problem and help position us for future clinical studies, says Dr. Ruslan Semechkin, Vice President, R&D.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com or follow us on Twitter @intlstemcell.

To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

Forward-looking Statements

Statements pertaining to anticipated developments, the potential benefits of research programs and new manufacturing technologies, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and technologies regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

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International Stem Cell Corporation Announces New Stem Cell Manufacturing Technologies to Support its Therapeutic ...

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'Cell shield' for cancer patients

May 11th, 2012 8:14 am

9 May 2012 Last updated at 14:14 ET By James Gallagher Health and science reporter, BBC News

It may be possible to use "stem cell shielding" to protect the body from the damaging effects of chemotherapy, early results from a US trial suggest.

Chemotherapy drugs try to kill rapidly dividing cancer cells, but they can also affect other healthy tissues such as bone marrow.

A study, in Science Translational Medicine, used genetically modified stem cells to protect the bone marrow.

Cancer Research UK said it was a "completely new approach".

The body constantly churns out new blood cells in the hollow spaces inside bone. However, bone marrow is incredibly susceptible to chemotherapy.

The treatment results in fewer white blood cells being produced, which increases the risk of infection, and fewer red blood cells, which leads to shortness of breath and tiredness.

Researchers at the Fred Hutchinson Cancer Research Center, in Seattle, said these effects were "a major barrier" to using chemotherapy and often meant the treatment had to be stopped, delayed or reduced.

They have tried to protect the bone marrow in three patients with a type of brain cancer, glioblastoma.

One of the researchers, Dr Jennifer Adair, said: "This therapy is analogous to firing at both tumour cells and bone marrow cells, but giving the bone marrow cells protective shields while the tumour cells are unshielded."

View original post here:
'Cell shield' for cancer patients

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