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California’s $70 Million ‘Alpha’ Stem Cell Clinic Plan Headed for Approval Next Week

By Dr. Matthew Watson

Alpha clinic organizational diagram
Graphic by CIRM
California's stem cell agency next week
is likely to approve a $70 million plan to build a taxpayer-financed
chain of  “Alpha” stem cell clinics in what could be a major step
towards making California the stem cell capital of the world,
The proposal would create five centers
at existing institutions or businesses to be funded at up to $11
million each over five years. Also proposed is a coordination and
information center that would receive $15 million over five years.
A story in Nature Medicine said that
the Alpha clinics would be the first-ever “clinical trials network focused around a broad therapeutic platform.”
The clinics are expected to draw stem
cell projects from the around the world as well as those
funded by the $3 billion California stem cell agency. The proposal
would be one of the largest single research efforts funded by the
agency, formally known as the California Institute for Regenerative
Medicine (CIRM)
and use about 10 percent of its remaining cash.
The Alpha clinics are aimed at creation
of a sturdy foundation for the stem cell industry in California,
capitalizing on the burgeoning, international lure of stem cell
treatments. Indeed, one of the objectives of the information center
is to divert people from dubious treatments elsewhere.
The plan would fill a “profound gap”
in quality information about stem cell treatments, according to a CIRM document, which said,

“By providing this resource, the public and potential patients
would be better educated and informed, whether or not they should opt
to enroll in clinical trials or approved treatments at any of the
Alpha clinics.”

The Alpha concept was first broached two years ago publicly by
CIRM President Alan Trounson, a pioneer in IVF research and the IVF
business. His proposal has received early and heavy
attention on the CIRM website with a video, blog items and a white paper.
The plan has received little critical
attention although a researcher from an institution that could be a
candidate for an Alpha clinic commented harshly in May on the California
Stem Cell Report,
calling the proposal “an irresponsible waste”and a “boondoggle for some medical schools.” The researcher, who
asked that he/she not be identified, said,

“CIRM will pay for an unneeded
infrastructure that will be empty space and staff sitting on their
hands 99 percent of the time.  Or worse yet, CIRM will pay but
the space will be used for other things, other clinic procedures paid
for by insurance.”  

Elie Dolgin's July 8 piece in Nature
Medicine quoted Mahendra Rao, director of the Center for Regenerative
Medicine
at the US National Institutes of Health (NIH), as applauding the concept. However, Rao said he doesn't
anticipate the approach being tried nationally soon.
Dolgin wrote,

“Rao regularly asks researchers
hoping to advance promising stem cell therapies whether they require
additional clinical infrastructure. 'So far, what they've told us is
they'll let us know if they need anything more than (the) programs
that we have already established,' he says.”

The question of the size of the demand
for Alpha clinics is not addressed in the CIRM concept plan. Also
absent is much discussion of the business aspects of the proposal. It
does mention “corporate sponsors” in passing. In a CIRM blog item
yesterday, Natalie DeWitt, special project director at the agency,
touched on business elements, declaring,

“(The proprosal) will yield better
clinical trial design, accelerated approval of high quality
treatments, and data and know-how to inform regulatory and
reimbursement decisions.”

Reimbursement is the industry euphemism
for creating ways to generate profits for stem cell firms.
The proposal said applicants would have
to bring substantial support from their own institutions and
“demonstrate the potential to bring in a pipeline of additional
stem cell-based therapeutic trials as well as future funding streams
to sustain the clinic.” Applicants would also be “evaluated in
their ability to create a positive 'brand' that would attract
clinical trials.”
Also up in the air was whether grant
reviewers, all of whom come from out-of-state, would have special
expertise to evaluate the business aspects of each applicant's
proposal along with their business track record.
What is before the CIRM directors July
25 at their meeting in Burlingame, Ca., is a request for approval of the concept, which
would be fleshed out for the RFA. The governing board almost always
approves staff concepts, although they may modify them slightly. A
number of directors come from institutions that are likely to be
applicants in the program. They can participate in voting on the
concept plan but would be barred from voting on any applications that
come in later. The two RFAs could go out as early as October with
approval of funding of applications one year from now.
In addition to the Burlingame meeting
site, members of the public can participate from two teleconference
locations in the Los Angeles area. The specific locations can be
found on the meeting agenda.
The California Stem Cell Report will
provide live coverage of the entire meeting, filing reports as
warranted based on the Internet audiocast.
Here are excerpts from CIRM's staff
document on the plan.

“To accelerate therapeutic
development and delivery of stem cell therapies, CIRM proposes
establishing the CIRM Alpha Stem Cell Clinics Network (CASC Network).
The network will be designed to support projects emanating from
CIRM’s funding pipeline, as well as scientifically outstanding stem
cell products being developed worldwide and brought to California.
Conceptually, the CASC Network is intended to be a sustainable
infrastructure designed to support academic- and industry-initiated
clinical trials, and delivery of therapies proven safe and
effective.”

“The major thrusts (of the overall
plan) will be:

• Development of clinical capacity
and associated resources designed to support the effective
implementation and execution of clinical trials and delivery of
registered stem cell therapies

• Compilation of data and
information concerning clinical trial experience and therapy outcomes
to further inform the research, regulatory, and general community
about the status of investigational stem cell interventions and
long-term outcomes

• Dissemination of information to
the public and counseling of patients and potential trial subjects
about therapeutic options and clinical trials involving stem cells in
the network and elsewhere.”

“The long-term vision is for the
Alpha Clinics to expand and accommodate a broad array of stem
cell-based clinical trials, where the trial meets the scientific,
clinical trial design and ethical standards set forth by the Alpha
Clinics Network, as well as FDA approved treatments.”

The coordinating and information center
would be expected to :
“Build relationships with
Accountable Care Organizations, and participate in initiatives for
informing coverage and payment decisions

“Design strategies to attract
investors and philanthropists to CASC network

“Create business plans, and marketing
and branding strategies for financial sustainability of the Alpha
Clinics Sites and (the coordination/information center)”.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/VhnrrutbBC0/californias-70-million-alpha-stem-cell.html

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Emilie Russler and David Germain – New York Times

By Dr. Matthew Watson

Emilie Russler and David Germain
New York Times
Next month, the bride, who is studying for a Ph.D. in immunology, is to begin her second year and the groom, studying for a doctorate in molecular genetics and genomics, his fifth. The bride's mother retired as the director and the deputy to the ...

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Indian Hill Music School donating sets and props for Newtown production – Boston Globe

By Dr. Matthew Watson


Boston Globe
Indian Hill Music School donating sets and props for Newtown production
Boston Globe
Wayland resident Lindsay Farrer (inset bottom) is a medical geneticist at the Boston University Schools of Medicine and Public Health, where he is a professor, chief of biomedical genetics, and director of the Molecular Genetics Core Facility. He ...

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Enhanced prostate cancer gene transfer and therapy using a novel serotype chimera cancer terminator virus (Ad.5/3?CTV)

By Dr. Matthew Watson

Abstract
Few options are available for treating patients with advanced prostate cancer (PC). As PC is a slow growing disease and accessible by ultrasound, gene therapy could provide a viable option for this neoplasm. Conditionally replication?competent adenoviruses (CRCAs) represent potentially useful reagents for treating prostate cancer (PC). We previously constructed a CRCA, Cancer Terminator Virus (CTV), which showed efficacy both in vitro and in vivo for PC. The CTV was generated on a serotype 5?background (Ad.5?CTV) with infectivity depending on Coxsackie?Adenovirus Receptors (CARs). CARs are frequently reduced in many tumor types, including PCs thereby limiting effective Ad?mediated therapy. Using serotype chimerism, a novel CTV (Ad.5/3?CTV) was created by replacing the ...

MedWorm Sponsor Message: Find the best Christmas presents and January Sales in the UK with this simple shopping directory.

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Stem Cell Therapy Treatment for Friedreichs Ataxia by Dr Alok Sharma, Mumbai, India. – Video

By daniellenierenberg


Stem Cell Therapy Treatment for Friedreichs Ataxia by Dr Alok Sharma, Mumbai, India.
Improvement seen in just 5 day after Stem Cell Therapy Treatment for Friedreichs Ataxia by Dr Alok Sharma, Mumbai, India. After Stem Cell Therapy 1. Speech has become much smoother and easier,...

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Can New Bone Be Made From Skin Stem Cells? – Video

By daniellenierenberg


Can New Bone Be Made From Skin Stem Cells?
Cartilage can be made from skin stem cells and now bone! In this video, Sharecare expert Michael Roizen, MD, chief wellness officer for Cleveland Clinic, exp...

By: SharecareVideo

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Can New Bone Be Made From Skin Stem Cells? - Video

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Stem Cell Therapy Docere Clinics – Video

By LizaAVILA


Stem Cell Therapy Docere Clinics

By: KeysToYoungerLiving

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Stem Cell Therapy Market in Asia-Pacific to 2018

By Sykes24Tracey

DUBLIN, July 18, 2013 /PRNewswire/ --

Research and Markets (http://www.researchandmarkets.com/research/qc7zk2/stem_cell_therapy) has announced the addition of the "Stem Cell Therapy Market in Asia-Pacific to 2018 - Commercialization Supported by Favorable Government Policies, Strong Pipeline and Increased Licensing Activity" report to their offering.

(Logo: http://photos.prnewswire.com/prnh/20130307/600769 )

Commercialization Supported by Favorable Government Policies, Strong Pipeline and Increased Licensing Activity

Stem Cell Research in Asia-Pacific a Growth Engine for Region's Scientific Ambitions

The stem cell therapy market in Asia-Pacific is poised to offer significant contributions in the future, thanks to renewed interest by the respective governments of India, China, Japan, South Korea and Singapore to provide cures for a range of diseases, states a new report by healthcare experts GBI Research.

Stem cells are unique body cells that possess the ability to divide and differentiate into diverse cell types, and can be used to produce more stem cells. The use of adult stem cells has been successfully employed to treat bone and blood related disorders such as leukemia, through bone marrow transplants. Stem cell therapy is used to repair and regenerate the damaged tissue, though the actual mechanism of action is largely unknown.

The growth in the stem cell therapy market will not only provide treatment options but will also contribute significantly to the countries' Gross Domestic Product (GDP), with the President of South Korea only last year referring to stem cell research as a new growth engine for the nation's economy. In order to support the stem cell industry, regulatory guidelines in Asia-Pacific countries allow stem cell research, and this has led to its commercialization. India and South Korea are the leaders in the commercialization of stem cell therapy, with approved products for Acute Myocardial Infarction (AMI), osteoarthritis and anal fistula in Crohn's disease, amongst others. The countries allow the use of human embryonic stem cells and provide adequate funding support for the research.

Stem cell therapy is an emerging field, and a large amount of research is currently being carried out by institutions such as hospitals, universities and medical colleges. According to GBI Research's analysis of the stem cell therapy research in Asia-Pacific, 63% of pipeline molecules were being researched by academia. The emergence of institutional research has boosted stem cell discoveries, as companies can be put off conducting research due to uncertain therapeutic outcomes. China and Japan witness only a negligible industry presence in stem cell research, as academic institutions dominate - however in contrast, India has the presence of both industry and academia. The major institutions engaged in stem cell research in India are LV Prasad Eye Institute (LYPEI) for Limbal Stem Cell Technology (LSCT), and the Post Graduate Institute of Medical Education and Research (PGIMER) for stem cell therapy for type 2 diabetes mellitus.

The market is poised for significant growth in the future, due to the anticipated launch of JCR Pharmaceuticals' JR-031 in Japan in 2014, and FCB Pharmicell's Cerecellgram (CCG) in South Korea in 2015. GBI Research therefore predicts that the stem cell therapy market will grow in value from $545m in 2012 to $972m in 2018, at a Compound Annual Growth Rate (CAGR) of 10%.

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Avascular necrosis treatment with bone marrow stem cells. – Video

By Dr. Matthew Watson


Avascular necrosis treatment with bone marrow stem cells.
Avascular necrosis treatment with stem cells from bone marrow. Visit http://www.blog.hipsurgery.in to get details of types of treatment. Visit http://www.hipsurgery...

By: ALAMPALLAM VENKATACHALAM

Excerpt from:
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Dr. Leslie Miller Named Chief Science Officer of Okyanos Heart Institute's Cardiac Stem Cell Therapy Treatment for …

By daniellenierenberg

Freeport, Bahamas (PRWEB) July 17, 2013

Okyanos Heart Institute, whose mission it is to bring a new standard of care and better quality of life to patients with coronary artery disease using cardiac stem cell therapy, has named Leslie Miller, M.D., F.A.C.C. as its chief science officer. Dr. Miller is a leading heart failure specialist and experienced thought leader in cardiac stem cell therapy. He is director of the University of South Florida (USF) Heart Institute, professor of cardiovascular sciences at the USF Health Morsani College of Medicine, and was formerly the director of cardiology at Georgetown University. Dr. Miller has been an investigator in over 80 clinical trials.

The use of adult stem cells derived from adipose (fat) tissue to treat congestive heart failure has the potential to change the game for the millions of patients suffering from this disease, said Miller. These stem and regenerative cells have been shown to stimulate the growth of new blood vessels, are anti-inflammatory and prevent at-risk cells from dying. These combined mechanisms can provide important therapeutic benefit to heart failure patients.

As a current member of Okyanos medical advisory council, Dr. Miller has actively advised us on patients criteria for cardiac stem cell therapy, says Okyanos Chief Medical Officer Howard Walpole. In this additional role as Chief Science Officer, he will be evaluating new research protocols and reporting on findings from the patient registry that will help advance the field of cardiac stem cell therapy. His experience and track record in leading academic research is outstanding. This integrated approach in research and clinical application in The Bahamas makes Okyanos Heart Institute one of the first places patients can receive new treatments.

Dr. Leslie Miller is a well-respected visionary in the field of cardiovascular disease says Okyanos CEO Matt Feshbach. This role will further advance our quality measures and the structure of our patient registry. We look forward to his contribution to improving the lives of patients using adult stem cells derived from their own fat tissue who, up until now, have exhausted their options with conventional treatments.

ABOUT OKYANOS HEART INSTITUTE: (Oh key AH nos) Based in Freeport, The Bahamas, Okyanos Heart Institutes mission is to bring a new standard of care and a better quality of life to patients with coronary artery disease using cardiac stem cell therapy. Okyanos adheres to U.S. surgical center standards and is led by Chief Medical Officer Howard T. Walpole Jr., M.D., M.B.A., F.A.C.C., F.A.C.A.I. Okyanos Treatment utilizes a unique blend of stem and regenerative cells derived from ones own adipose (fat) tissue. The cells, when placed into the heart via a minimally-invasive catheterization, stimulates the growth of new blood vessels, a process known as angiogenesis. The treatment facilitates blood flow in the heart and supports intake and use of oxygen (as demonstrated in rigorous clinical trials such as the PRECISE trial). The literary name Okyanos (Oceanos) symbolizes flow. For more information, go to http://www.okyanos.com/.

NEW MEDIA CONTENT: Okyanos LinkedIn page: http://www.linkedin.com/company/okyanos-heart-institute

Okyanos Facebook page: https://www.facebook.com/OKYANOS

Okyanos Twitter page: https://twitter.com/#!/OkyanosHeart

END

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Stem Cell Therapy Treatment for Idiopathic Polymyositis by Dr Alok Sharma, Mumbai, India. – Video

By Dr. Matthew Watson


Stem Cell Therapy Treatment for Idiopathic Polymyositis by Dr Alok Sharma, Mumbai, India.
Improvement seen in just 5 day after Stem Cell Therapy Treatment for Idiopathic Polymyositis by Dr Alok Sharma, Mumbai, India. After Stem Cell Therapy 1. Fle...

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Stem Cell Therapy Treatment for Left Hemiplegic Cerebral Palsy by Dr Alok Sharma, Mumbai, India. – Video

By JoanneRUSSELL25


Stem Cell Therapy Treatment for Left Hemiplegic Cerebral Palsy by Dr Alok Sharma, Mumbai, India.
Improvement seen in just 5 day after Stem Cell Therapy Treatment for Left Hemiplegic Cerebral Palsy by Dr Alok Sharma, Mumbai, India. After Stem Cell Therapy...

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Stem Cell Therapy Treatment for Autism by Dr Alok Sharma, Mumbai, India. Part 2 – Video

By LizaAVILA


Stem Cell Therapy Treatment for Autism by Dr Alok Sharma, Mumbai, India. Part 2
Improvement seen in just 7 months after Stem Cell Therapy Treatment for Autism by Dr Alok Sharma, Mumbai, India. After Stem Cell Therapy 1. Emotional respons...

By: Neurogen Brain and Spine Institute

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Stem Cell Therapy Treatment for Cerebral Atrophy by Dr Alok Sharma, Mumbai, India. Part 2 – Video

By LizaAVILA


Stem Cell Therapy Treatment for Cerebral Atrophy by Dr Alok Sharma, Mumbai, India. Part 2
Improvement seen in just 5 day after Stem Cell Therapy Treatment for Cerebral Atrophy by Dr Alok Sharma, Mumbai, India. After Stem Cell Therapy 1. Ball throw...

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Cell Therapy – Technologies, Markets and Companies – Updated 2013 with New Companies and Profiles

By JoanneRUSSELL25

DUBLIN, July 16, 2013 /PRNewswire/ --

Research and Markets ( http://www.researchandmarkets.com/research/dhdp3r/cell_therapy) has announced the addition of Jain PharmaBiotech's new report "Cell Therapy - Technologies, Markets and Companies" to their offering.

(Logo: http://photos.prnewswire.com/prnh/20130307/600769 )

This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.

Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.

Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.

Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.

Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.

The cell-based markets were analyzed for 2012, and projected to 2022. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 287 of these are profiled in part II of the report along with tabulation of 273 alliances. Of these companies, 158 are involved in stem cells. Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 55 Tables and 12 Figures. The bibliography contains 1,050 selected references, which are cited in the text.

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Cell Therapy - Technologies, Markets and Companies - Updated 2013 with New Companies and Profiles

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stem cell therapy for Sports injuries. – Video

By LizaAVILA


stem cell therapy for Sports injuries.
Videos is about the Stem Cell Treatment provided to various athletes and sports persons. Dr. Purita had provided treatment for the knee, elbow, shoulder, wri...

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Life stem cell therapy Purtier – Video

By raymumme


Life stem cell therapy Purtier
9 years old girl benefited from deer placenta.

By: Keith Chew

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Wisconsin Alumni Research Foundation ranks fourth in biotechnology patents – 77Square.com

By Dr. Matthew Watson

Wisconsin Alumni Research Foundation ranks fourth in biotechnology patents
77Square.com
Bioentrepreneur, a website affiliated with the journal Nature, has ranked UW-Madison's Wisconsin Alumni Research Foundation (WARF) the fourth-most-active entity in biotechnology patents issued in the U.S. and Europe from 2008 to 2012. In that span ...

Source:
http://news.google.com/news/url?sa=t&fd=R&usg=AFQjCNGQOLEBzDDMnFMht0qfe1OUoFdLNg&url=http://host.madison.com/wsj/news/local/education/university/wisconsin-alumni-research-foundation-ranks-fourth-in-biotechnology-patents/article_ceb5524f-8c64-5bae-98d4-5fd7e9450524.html

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Is Alynlam the next breakthrough name in biotechnology? Investors say ‘yes’ – MedCity News

By Dr. Matthew Watson


Boston Globe
Is Alynlam the next breakthrough name in biotechnology? Investors say 'yes'
MedCity News
(Reuters) - A radical new treatment for genetic disorders has catapulted Alnylam Pharmaceuticals Inc into the crosshairs of investors seeking the next breakthrough name in biotechnology. The challenge for the Cambridge, Massachusetts-based company ...
Stocks to Keep Your Eyes on - Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN ...Techsonian
Alnylam Pharmaceuticals (ALNY) Shares Soar After Positive Drug Trial ResultsNew Stuff Here
Alnylam Reports Positive Top-Line Results for ALN-TTRsc, a Subcutaneously ...EON: Enhanced Online News (press release)

all 32 news articles »

Source:
http://news.google.com/news/url?sa=t&fd=R&usg=AFQjCNEz5ensUYZAz22zl7md7KPcZtVDCQ&url=http://medcitynews.com/2013/07/is-alynlam-the-next-breakthrough-name-in-biotechnology-investors-say-yes/

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ThyssenKrupp inaugurated biotechnology in Leuna – SteelGuru

By Dr. Matthew Watson

ThyssenKrupp inaugurated biotechnology in Leuna
SteelGuru
Dr. Heinrich Hiesinger CEO of ThyssenKrupp said that “Modern biotechnology is one of the key technologies of the 21st century. Biotechnological processes, products and services play a role in almost all areas of our daily lives for example in the ...

Source:
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