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A short and sweet note to point you to a great article on bioreactor technologies related to cell therapy bioprocessing by CTG consultant and Director of Stem Cell-based Drug Discovery, John E. Hambor, who you can now follow on Twitter @StemCellonDrugs.


"Bioreactor Design and Bioprocess Controls for Industrialized Cell Processing" was published in the June issue of BioProcess International.  


The BPI team has made a real and meaningful commitment to representing cell therapy bioprocessing and we applaud them for their contribution to this emerging discipline.




If this is a topic of interest to you, I recommend you also check out a conference being held this Fall by BPI's sister company, IBC LifeSciences, entitled "Cell Therapy BioProcessing" to be held September 11-12 in Arlington, Virginia.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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The California stem cell agency is
considering adding more cash to its upcoming $30 million award round
aimed at aiding projects that can complete – within the next four
years – a clinical trial for a therapy.

“The Strategic Partnership Funding
Program represents a new era for CIRM, one that is increasingly
focused on moving therapies from the lab to the clinic, while still
recognizing the importance of maintaining investments in early stage
science,”

"We received 37 letters of intent
(LOIs), including 8 from non-profits and 29 from biotech companies.
 Based on the information in the LOIs, and on discussions with
applicants, we were able to determine that some of the proposals were
for projects that were outside the scientific scope of the RFA and
that some of the applicants did not meet the minimum specified
criteria in the RFA for 'Commercial Validation.' We currently expect
to receive 10-15 applications for projects that appear to be
eligible."

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

Jill Helms, Stanford photo

Zhenyu Tang (at microscope) examines vascular stem cells in culture along with Aijun Wang (left) and Song Li. UC Berkeley/Zoey Huang photo

"Even though he works just across
the (San Francisco) Bay from me - I met him at a meeting in Japan
that was sponsored by the California Institute for Regenerative
Medicine, or CIRM, and they fund a lot of stem cell research in
California."

"I will tell you that cancer is
certainly a disease that looks very much like a stem cell gone out of
control. And so if we understand what normally regulates a stem
cell's behavior, then we gain some crucial insights into what
regulates maybe a cancer cell's behavior. It's that kind of approach
that I think that CIRM is largely funding initiatives to try to
target human diseases, the big ones, and the ones that make us all
sort of quake in our shoes, and attempt to come up with new
therapies."

"Most basic scientists that work
in stem cells and in the area of stem cell are trying as hard as
possible to move this into translational therapies, things that can
be used in humans. And, of course, CIRM, our funding institution, is
very adamant about this being the trajectory. So, you know, I'll be
taking a stab at it about five to seven years. I think that the
ability to rapidly screen existing drugs for their ability to target
this cell population is why we think that it might have a shorter
course to getting into humans."

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

Boston Globe

BIO comes back Boston.com More than 15000 people arriving in Boston for the Biotechnology Industry Organization convention opening Monday will see a Massachusetts life sciences ... Marshall, spinoffs to be featured at biosciences conferenceWOWK Europe's biotech firms flocking to Bay StateBoston Globe Former Secretary of Health and Human Services to Lead Panel at ...PharmaLive.com (press release) CNBC.com -NECN -Huntington Herald Dispatch all 20 news articles »

Source:
http://news.google.com/news?q=biotechnology&output=rss

Unveilling stem cells

LAWRENCE SERETSE Correspondent

Cryo-Save, the European company that intends to establish the first stem cell bank in Botswana says stem cells do not have just one function. They can themselves become or create other types of cells such as blood cells, brain cells, tissue cells, muscle cells and the like. Stem cells can be found in every person but they are much more numerous in the body of a foetus.

There are three types of stem cell banking namely, the baby stem cell banking which is the preservation and storage of cord blood and umbilical cord tissue. Adult stem cell banking is the preservation and storage of peripheral blood (from blood stream for bone marrow transplants) and fatty tissue stem cells.

The reproductive cell banking deals with the preservation and storage of eggs and sperm for future fertility treatments or artificial insemination purposes. Studying stem cells helped humans understand how they transform into the dazzling array of specialised cells that make us what we are. Some of the most serious medical conditions, such as cancer and birth defects, are caused by problems that occur somewhere in this process. A better understanding of normal cell development has allowed scientists to understand and perhaps correct the errors that cause these medical conditions. Many support stem cell research because it has the potential to provide solutions to a wide variety of medical conditions and diseases.

Stem cell research could even lead to a cure for some of the most traumatic injuries and diseases. Stem cell treatments cure over 70 diseases and disorders like Leukemia, Lymphoma, blood cancers, bone marrow disorders like Aplastic anaemia, sickle cell, Diabetes, Alzheimer's Disease, heart disease, stroke, birth defects, spinal cord injuries, ability to replace or repair organs and cancer.

This is just half of it. If one just looked at the benefits one might wonder why stem cell treatments are not in wide use. The shortcomings of stem cell research are often fears of what could result from such knowledge and the moral implications of using the stem cells. There are worries that humans should not try to play God. "Relating bodies have to pay extra caution and determine if we really need these banks. Again, some researchers may be coming to dig stem cells in Botswana, since there maybe restrictive laws in their countries.

"The unsuspecting citizens may end up giving up their stem cells for money," says Iqbal Chand, the CEO of Diagnofirm Medical Laboratories. He gave a scenario from recent publications that a patient in Berlin was cleared of HIV after stem cell treatment for leukemia.

"We do not even know how true it is and if it was the stem cells that cured his HIV. Even if it is, it is one person in a million so there is no assurance," Chand pointed out.

Another big issue with stem cells research is superstition. In most African communities, the umbilical cord must be buried after birth because it is believed that anyone with access to it could exert some spiritual influence on the child. This has led to uncertainty towards cord tissue and cord blood storage in most African societies. However, with the success of transplants making the headlines, more and more people are willing to donate adult stem cells to save lives.

See the original post:
Unveilling stem cells

wwltv.com

Posted on June 15, 2012 at 5:53 PM

Updated today at 6:12 PM

Meg Farris / Eyewitness News Email: mfarris@wwltv.com | Twitter: @megfarriswwl

NEWORLEANS- She was only in kindergarten when doctors gave her family the bad news.

Now she's one of the first in Louisiana to try a new treatment for people who get gravely ill after a bone marrow transplant.

The last three years of Sami Smith's life have been physically and emotionally painful.

"I literally, they try to scare me and they can't, because I've been through the scariest thing that you can," said Smith, 9, of Ponchatoula.

Her mother noticed she was napping more and bruising. Doctors diagnosed AML, a type of leukemia or blood cancer. Had she not gotten to the doctor then, she would not have made it much longer. A Child's Wish sent her to Disney World. The good news, one of her teen sisters Mary Hannah, 13, was a good bone marrow match. The transplant worked and Sami was cancer free.

Then devastating news. Sami got a condition called GvHD (Graft-versus-host disease) where the new marrow launches a painful attack on the recipient's body. It's the leading cause of transplant-related death.

More:
Stem cell treatment offers hope to those sickened after getting bone marrow

SAN DIEGO, CA--(Marketwire -06/15/12)- Bio-Matrix Scientific Group (BMSN) (BMSN) announced today the appointment of David Audley to the advisory board of Its Regen BioPharma subsidiary. Mr. Audley will advise Regen BioPharma on strategic leveraging of national and international clinical research resources. Mr. Audley is viewed by the Company as a key component in the commercialization of stem cell intellectual property. Additionally, it is anticipated that he will assist in raising international awareness for the regenerative therapies being developed by the Company.

In his function as executive director and CEO of the International Cellular Medicine Society (ICMS), Mr. Audley has spearheaded development and implementation of global guidelines for accreditation of stem cell clinics. Under his leadership, the ICMS has grown from a loose association of a handful of physicians to a major international standards organization with over 3500 members from 36 countries. He is a strong advocate for stem cell therapy development and implementation, and is the chief architect of the ICMS accreditation program that is currently evaluating the practices of nearly 20 facilities in a dozen countries. Mr. Audley also has strong professional relationships with Ministries of Health and governmental agencies in South America, Asia and the Middle East.

"My work at ICMS exposes me to the tremendous ability of stem cell therapeutics to alleviate human suffering. Unfortunately, business models have not caught up with the medical reality. Regen BioPharma is unique in that to my knowledge they are the first group to develop a model that accelerates development of stem cell therapeutics in a win-win situation for investors and patients," said David Audley.

"Mr. Audley has made a substantial impact in the clinical translation of stem cell therapeutics by establishing standards, accreditations, an Institutional Review Board (IRB), and partnerships with major organizations such as the AABB," said Christopher Mizer, President of Regen BioPharma. "We are extremely excited to work side by side with Mr. Audley in accelerating access of new stem cell therapies for patients."

About Bio-Matrix Scientific Group, Inc. and Regen BioPharma, Inc.:

Bio-Matrix Scientific Group, Inc. (BMSN) (BMSN) is a biotechnology company focused on the development of regenerative medicine therapies and tools. The Company is focused on human therapies that address unmet medical needs. Specifically, Bio-Matrix Scientific Group, Inc. is looking to increase the quality of life through therapies involving stem cell treatments. These treatments are focused in areas relating to cardiovascular, hematology, oncology and other indications.

Through Its wholly owned subsidiary, Regen BioPharma, it is the Company's goal to develop translational medicine platforms for the rapid commercialization of stem cell therapies. The Company is looking to use these translational medicine platforms to advance intellectual property licensed from entities, institutions and universities that show promise towards fulfilling the Company's goal of increased quality of life. To follow our development, visit us at http://www.regenbiopharma.com.

Disclaimer

This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

Visit link:
Bio-Matrix Scientific Group Announces David Audley, the Founder of International Cellular Medicine Society, Has Joined ...

Highly-magnified red blood cells course through a vein. Picture: file Source: Supplied

DOCTORS in Sweden successfully replaced a potentially-fatal blocked vein in a 10-year-old girl with one grown from her own stem cells, according to a study published today.

The team - from the University of Gothenburg andSahlgrenska University Hospital - accomplished the feat by populating a section of vein from a dead donor using stem cells gleaned from the girl's bone barrow.

"The new stem-cells-derived graft resulted not only in good blood flow rates and normal laboratory test values but also, in strikingly improved quality of life for the patient," the study's authors wrote in The Lancet.

The successful feat also "opens interesting new areas of research," they added.

The operation marked the latest step in scientists' ability to create replacement organs for transplant.

In 2010, doctors at London's Great Ormond Street Hospital made history by successfully transplanting a donor windpipe into a young boy, also aged 10, that was regenerated inside his body using his own stem cells.

In the latest instance, a 3.5-inch (9cm) section of groin vein from the donor was stripped of any living cells and "recellularised" with new cells grown from stem cells taken from the girl's bone marrow.

Techniques that use stem cells from a patient's own body carry the major benefit that they do not provoke an immune response. In the Swedish case, one alternative treatment option was a liver transplant, which would have required a lifetime of immunosuppressants. The work was funded by the Swedish government.

Visit link:
Vein grown from girl's stem cells

For the first time doctors have successfully transplanted a vein grown with a patient's own stem cells, another example of scientists producing human body parts in the lab.

In this case, the patient was a 10-year-old girl in Sweden who was suffering from a severe vein blockage to her liver. Last March, the girl's doctors decided to make her a new blood vessel to bypass the blocked vein instead of using one of her own or considering a liver transplant.

They took a 9-centimetre section of vein from a deceased donor, which was stripped of all its cells, leaving just a hollow tube. Using stem cells from the girl's bone marrow, scientists grew millions of cells to cover the vein, a process that took about two weeks. The new blood vessel was then transplanted into the patient.

Because the procedure used her own cells, the girl did not have to take any drugs to stop her immune system from attacking the new vein, as is usually the case in transplants involving donor tissue.

"This is the future for tissue engineering, where we can make tailor-made organs for patients," said Suchitra Sumitran-Holgersson of the University of Gothenburg, one of the study's authors.

She and colleagues published the results of their work online Thursday in the British medical journal Lancet. The work was paid for by the Swedish government.

The science is still preliminary and one year after the vein was transplanted, it needed to be replaced with another lab-grown vein when doctors noticed the blood flow had dropped. Experts from University College London raised questions in an accompanying commentary about how cost-effective the procedure might be, citing "acute pressures" on health systems that might make these treatments impractical for many patients.

Sumitran-Holgersson estimated the cost at between $6,000 and $10,000.

Similar methods have already been used to make new windpipes and urethras for patients. Doctors in Poland have also made blood vessels grown from donated skin cells for dialysis patients.

Patients with the girl's condition are usually treated with a vein transplant from their own leg, a donated vein, or a liver transplant. Those options can be complicated in children and using a donated vein or liver also requires taking anti-rejection medicines.

Original post:
Vein grown from girl's own stem cells transplanted

ScienceDaily (June 14, 2012) Six new human embryonic stem cell lines derived at the University of Michigan have just been placed on the U.S. National Institutes of Health's registry, making the cells available for federally-funded research.

U-M now has a total of eight cell lines on the registry, including five that carry genetic mutations for serious diseases such as the severe bleeding disorder hemophilia B, the fatal brain disorder Huntington's disease and the heart condition called hypertrophic cardiomyopathy, which causes sudden death in athletes and others.

Researchers at U-M and around the country can now begin using the stem cell lines to study the origins of these diseases and potential treatments. Two of the cell lines are believed to be the first in the world bearing that particular disease gene.

The three U-M stem cell lines now in the registry that do not carry disease genes are also useful for general studies and as comparisons for stem cells with disease genes. In all, there are 163 stem cell lines in the federal registry, most of them without major disease genes.

Each of the lines was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. The embryos carrying disease genes were created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation and would have otherwise been discarded if not donated by the couples who donated them.

Some came from couples having fertility treatment at U-M's Center for Reproductive Medicine, others from as far away as Portland, OR. Some were never frozen, which may mean that the stem cells will have unique characteristics and utilities.

The full list of U-M-derived stem cell lines accepted to the NIH registry includes:

"Our last three years of work have really begun to pay off, paving the way for scientists worldwide to make novel discoveries that will benefit human health in the near future," says Gary Smith, Ph.D., who derived the lines and also is co-director of the U-M Consortium for Stem Cell Therapies, part of the A. Alfred Taubman Medical Research Institute.

"Each cell line accepted to the registry demonstrates our attention to details of proper oversight, consenting, and following of NIH guidelines," says Sue O'Shea, Ph.D., professor of Cell and Developmental Biology at the U-M Medical School, and co-director of the Consortium for Stem Cell Therapies.

U-M is one of only three academic institutions to have disease-specific stem cell lines listed in the national registry, says Smith, who is a professor in the Department of Obstetrics and Gynecology at the University of Michigan Medical School. The first line, a genetically normal one, was accepted to the registry in February.

Here is the original post:
Six new stem cell lines now publicly available

SAN DIEGO, June 15, 2012 /PRNewswire/ --ViaCyte, Inc. today announced the appointment of seasoned entrepreneur, Paul Laikind, Ph.D., as President & Chief Executive Officer. Allan Robins, Ph.D., who was serving as Acting CEO, will continue in his role as Vice President & Chief Technology Officer. ViaCyte is a leading pre-clinical company developing a novel cell therapy product for the treatment of insulin dependent diabetes.

Dr. Laikind brings over 25 years of leadership experience in the biotechnology and life sciences industry to ViaCyte. He is a serial entrepreneur, who co-founded three San Diego companies, Gensia Pharmaceuticals Inc., Viagene Inc., and Metabasis Therapeutics Inc., serving in various executive positions including President and CEO. All three companies went public and were eventually acquired. Most recently, he served as Chief Business Officer and Senior Vice President of Business Development at the Sanford-Burnham Medical Research Institute.

"Paul brings to ViaCyte a wealth of experience in managing new businesses based on highly innovative life sciences technologies," said Fred Middleton, Chairman of ViaCyte. "We are pleased to have him join to lead ViaCyte through our next phase of development in bringing our transformative stem cell therapy to patients with diabetes. We believe Paul's leadership and business development skills will greatly assist us in our strategy to be a leader in regenerative medicine therapy and to capitalize on our current technology leadership position in the development of stem cell therapy."

As Sanford-Burnham's first Chief Business Officer, Dr. Laikind set a new direction for the Institute's business development activity through a combination of licensing and strategic partnerships with large pharmaceutical organizations, including collaborations with Pfizer's Centers for Therapeutic Innovation, Ortho-McNeil-Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, and Takeda Pharmaceutical. Working with the Institute's leadership team he helped establish a sophisticated infrastructure for advanced drug discovery and development at Sanford-Burnham.

Prior to Sanford-Burnham, Dr. Laikind served as President & CEO from 1999-2008 for Metabasis Therapeutics, which developed new therapies for metabolic and liver diseases. Dr. Laikind co-founded Gensia Pharmaceuticals in 1986, was a board member of the company and held various executive leadership positions. While at Gensia he was responsible for establishing a number of important strategic partnerships. In 1997, he was part of a team that restructured Gensia to focus on specialty pharmaceuticals. The restructured company was renamed Gensia Sicor and went on to be acquired for over $3 billion by Teva Pharmaceutical Industries in 2004. Soon after founding Gensia, he was co-founder of Viagene, a gene therapy company. Viagene completed an initial public offering in 1993 and was acquired in 1995 by Chiron Inc., now a subsidiary of Novartis Vaccines & Diagnostics.

Dr. Laikind earned his Ph.D. in biochemistry from the University of California, San Diego and is the inventor on a number of key patents.

"ViaCyte addresses one of the largest commercial and medical opportunities in stem-cell-derived therapeutics, and its team is internationally recognized for its scientific leadership," said Dr. Laikind. "I look forward to working with ViaCyte through clinical development and market launch of its first important product that promises to change the way we treat insulin dependent diabetes."

About ViaCyte

ViaCyte is a preclinical cell therapy company focused on diabetes. The Company's technology is based on pancreatic beta cell progenitors derived from human pluripotent stem cells. These cells are implanted using a durable and retrievable encapsulation device. Once implanted and matured, these cells secrete insulin in response to blood glucose levels. ViaCyte's goal is long term insulin independence without immune suppression, and without hypoglycemia and other diabetes-related complications.

ViaCyte is a private company headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine.

Read the rest here:
ViaCyte Appoints Dr. Paul Laikind Chief Executive Officer

Twelve stem cell researchers from Yale received $6.75 million from the Connecticut Stem Cell Fund, according to figures supplied by the states Department of Health.

The amount was the largest ever awarded to Yale since the state legislature in 2005 designated $100 million over 10 years to promote stem cell research in Connecticut. Connecticut was the third state to pass legislation authorizing use of funds to study human embryonic stem cells.

Stem cell researchers at Yale very much appreciate Connecticuts vision and determination in supporting this research despite the challenging economy, said Haifan Lin, director of the Yale Stem Cell Center. In return, our work along with research conducted at the University of Connecticut and Wesleyan has made our state a leader in stem cell research and already positively impacted the state economy.

Yale scientists who received major grants and their research goals are:

Eugene Redmond $1.8 million for treatment of Parkinsons disease using neurons derived from stem cells.

Valerie Horsley $750,0000 for generation of skin cells.

Jeffrey Kocsis $750,000 for use of embryonic cells to remyelinate spinal cord tissue.

Yibing Qyang $750,000 for generation of tissue-engineered blood vessels.

Natalia Ivanova $750,000 for the study of how embryonic stem cells control cell fate.

In-Hyun Park $750,000 for regeneration of neurons.

Excerpt from:
Twelve Yale faculty receive grants for work with embryonic stem cells

Highly-magnified red blood cells course through a vein. Picture: file Source: Supplied

DOCTORS in Sweden successfully replaced a potentially-fatal blocked vein in a 10-year-old girl with one grown from her own stem cells, according to a study published today.

The team - from the University of Gothenburg andSahlgrenska University Hospital - accomplished the feat by populating a section of vein from a dead donor using stem cells gleaned from the girl's bone barrow.

"The new stem-cells-derived graft resulted not only in good blood flow rates and normal laboratory test values but also, in strikingly improved quality of life for the patient," the study's authors wrote in The Lancet.

The successful feat also "opens interesting new areas of research," they added.

The operation marked the latest step in scientists' ability to create replacement organs for transplant.

In 2010, doctors at London's Great Ormond Street Hospital made history by successfully transplanting a donor windpipe into a young boy, also aged 10, that was regenerated inside his body using his own stem cells.

In the latest instance, a 3.5-inch (9cm) section of groin vein from the donor was stripped of any living cells and "recellularised" with new cells grown from stem cells taken from the girl's bone marrow.

Techniques that use stem cells from a patient's own body carry the major benefit that they do not provoke an immune response. In the Swedish case, one alternative treatment option was a liver transplant, which would have required a lifetime of immunosuppressants. The work was funded by the Swedish government.

Original post:
Vein grown from 10-year-old girl's stem cells

LONDON: Scientists have successfully transplanted a vein made from a 10-year-old girl's own stem cells into her body. It is the first time such an operation has been reported and marks an important step in the practical ability of doctors to use stem cells to grow replacement cells for damaged or diseased tissue.

Writing in the medical journal The Lancet, a team led by Professor Suchitra Sumitran-Holdgersson, of the University of Gothenburg in Sweden, described how the girl had a blocked hepatic portal vein, which takes blood away from the gut and spleen to the liver.

The blockage can lead to complications including internal bleeding, developmental problems and even death. The usual treatment for the condition is to remove the blocked vein and replace it with sections of healthy vein from other parts of the body.

Advertisement: Story continues below

The team instead grew a vein for the young girl using her own bone marrow stem cells.

They started with a nine-centimetre section of vein taken from the groin of a donor and stripped it of its cells, leaving behind a tubular protein scaffold. This was seeded with the girl's stem cells and the resulting vein was transplanted into the girl.

The procedure restored blood flow out of her liver immediately.

''The patient increased in height from 137 to 143 centimetres and increased in weight from 30 to 35 kilograms in the one year since the first operation,'' the authors wrote. ''Although we undertook no neurocognitive tests, the parents reported that the patient had enhanced physical activity (increased long distance walks of two to three kilometres and light gymnastics) and improved articulated speech and concentration power in school activities.''

Nine months after the operation, the vein had constricted slightly in size and this was corrected in a follow-up procedure. Most significantly, scientists found no antibodies for the donor vein in the girl's blood. Her body was not rejecting the transplant because it was recognised as being made of her own cells.

''The young girl in this report was spared the trauma of having veins harvested from the deep neck or leg with the associated risk of lower limb disorders, and avoided the need for a liver or multivisceral transplantation,'' Professors Martin Birchall and George Hamilton of University College London wrote in an accompanying commentary article in The Lancet.

Read this article:
Girl gets vein grown from her own stem cells for transplant

1:00 AM Since the new vein was transplanted, the 10-year-old with blockage to her liver is much improved.

The Associated Press

LONDON - For the first time doctors have successfully transplanted a vein grown with a patient's own stem cells, another example of scientists producing human body parts in the lab.

In this case, the patient was a 10-year-old girl in Sweden who was suffering from a severe vein blockage to her liver. Last March, the girl's doctors decided to make her a new blood vessel to bypass the blocked vein instead of using one of her own or considering a liver transplant.

They took a 3-inch section of vein from a deceased donor, which was stripped of all its cells, leaving just a hollow tube. Using stem cells from the girl's bone marrow, scientists grew millions of cells to cover the vein, a process that took about two weeks. The new blood vessel was then transplanted into the patient.

Because the procedure used her own cells, the girl did not have to take any drugs to stop her immune system from attacking the new vein, as is usually the case in transplants involving donor tissue.

"This is the future for tissue engineering, where we can make tailor-made organs for patients," said Suchitra Sumitran-Holgersson of the University of Gothenburg, one of the study's authors.

She and colleagues published the results of their work online Thursday in the medical journal Lancet. The work was paid for by the Swedish government.

The science is still preliminary, and one year after the vein was transplanted, it needed to be replaced with another lab-grown vein when doctors noticed the blood flow had dropped. Experts from University College London raised questions in an accompanying commentary about how cost-effective the procedure might be, citing "acute pressures" on health systems that might make these treatments impractical for many patients.

Similar methods have already been used to make new windpipes and urethras for patients. Doctors in Poland have also made blood vessels grown from donated skin cells for dialysis patients.

Original post:
Girl's stem cells used to make her a new vein

LONDON For the first time doctors have successfully transplanted a vein grown with a patients own stem cells, another example of scientists producing human body parts in the lab.

In this case, the patient was a 10-year-old girl in Sweden who was suffering from a severe vein blockage to her liver. Last March, the girls doctors decided to make her a new blood vessel to bypass the blocked vein instead of using one of her own or considering a liver transplant.

They took a 3-1/2-inch section of vein from a deceased donor, which was stripped of all its cells, leaving just a hollow tube. Using stem cells from the girls bone marrow, scientists grew millions of cells to cover the vein, a process that took about two weeks. The new blood vessel was then transplanted into the patient.

Because the procedure used her own cells, the girl did not have to take any drugs to stop her immune system from attacking the new vein, as is usually the case in transplants involving donor tissue.

This is the future for tissue engineering, where we can make tailor-made organs for patients, said Suchitra Sumitran-Holgersson of the University of Gothenburg, one of the studys authors.

She and colleagues published the results of their work online Thursday in the British medical journal Lancet. The work was paid for by the Swedish government.

The science is still preliminary and one year after the vein was transplanted, it needed to be replaced with another lab-grown vein when doctors noticed the blood flow had dropped. Experts from University College London raised questions in an accompanying commentary about how cost-effective the procedure might be, citing acute pressures on health systems that might make these treatments impractical for many patients.

Sumitran-Holgersson estimated the cost at between $6,000 and $10,000.

Similar methods have already been used to make new windpipes and urethras for patients. Doctors in Poland have also made blood vessels grown from donated skin cells for dialysis patients.

Patients with the girls condition are usually treated with a vein transplant from their own leg, a donated vein, or a liver transplant. Those options can be complicated in children and using a donated vein or liver also requires taking anti-rejection medicines.

View post:
Vein grown from stem cells

June 14, 2012, SEATTLE /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced that former OncoMed Pharmaceuticals executive, Steven E. Benner, M.D., M.H.S., has joined CTI as Executive Vice President and Chief Medical Officer ("CMO"), reporting to James A. Bianco, M.D., Chief Executive Officer. Dr. Benner will take over all drug development activities at the company.Dr. Benner was previously senior vice president and chief medical officer at OncoMed, a venture-backed biotechnology company focused on the development of cancer stem cell targeting agents. Prior to OncoMed, he was CMO at Protein Design Labs ("PDL"), where he was accountable for all development activities including clinical development, clinical operations, biometry, regulatory affairs, and safety. He also served as Chair of the Portfolio and Clinical Development Management Committees of PDL. Before PDL he held several senior executive roles at Bristol-Myers Squibb in global development, life cycle management, and licensing and alliances.

"Dr. Benner brings to CTI his proven track record of success in advancing the development of innovative therapies for cancer patients," said Dr. Bianco. "His appointment is the first step in re-aligning our portfolio efforts, as we focus on advancing pacritinib into Phase III pivotal studies later this year."

With the new company initiative of the planned Pixuvri launch in Europe later this year, Jack W. Singer, M.D., will assume the newly-created role of Executive Vice President ("EVP") of Global Medical Affairs and Translational Medicine, responsible for cancer drug development strategy, global medical affairs, and life cycle management.

"Given Jack's impressive academic credentials, the respect he receives from an international network of key opinion leaders in the field, and his track record in oncology drug development, this was a natural promotion as we introduce Pixuvri in Europe," said Dr. Bianco.

"CTI has assembled an impressive late-stage portfolio of novel targeted therapies that address a spectrum of blood related cancers," said Dr. Benner. "With two drugs in Phase III and two more expected to enter Phase III trials within a year, this is an exciting and transformational time to join the team at CTI."

About Pixuvri (pixantrone)Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds,Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity, and, because Pixuvri is not a vesicant, allow it to be safely delivered via a peripheral intravenous catheter.

In May 2012 Pixuvri received conditional marketing authorization in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/communityregister/html/h764.htm#ProcList.

Pixuvri is currently available in the EU through Named Patient Programs.

Pixuvri does not have marketing approval in the United States.

About Conditional Marketing AuthorizationSimilar to accelerated approval regulations inthe United States, conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessmentthat address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

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Cell Therapeutics Appoints New Chief Medical Officer

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the company is presenting at two upcoming conferences: the 2012 Bio International Convention and Clinical Outlooks for Regenerative Medicine meeting, both in Boston, on Tuesday, June 19. The presentations will cover the companys three ongoing clinical trials using human embryonic stem cell-derived retinal pigment epithelial cells to treat macular degeneration, and other programs.

Gary Rabin, chairman and CEO, will present at the 2012 Bio International Convention on Tuesday, June 19 at 8:15 a.m. EDT, at the Boston Convention & Exhibition Center.

Matthew Vincent, Ph.D., director of business development, will present at the Clinical Outlooks for Regenerative Medicine meeting at 9:15 a.m. EDT on the same date, at the Starr Center, Schepens Eye Research Institute, at 185 Cambridge Street in Boston.

Both presentation slide decks will be available on the conference presentations section of the ACT website.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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Advanced Cell Technology to Present at the 2012 Bio International Convention and the Clinical Outlooks for ...

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

International Stem Cell Corporation (ISCO) http://www.internationalstemcell.com announced that scientists in its wholly-owned subsidiary, Lifeline Cell Technology (LCT), have developed a technology to modify human stem cells by using engineered proteins, called "transducible transcription factors" or "TTFs." TTFs are designed to pass into stem cells and direct the stem cells to change into specific cell types that can be both therapeutically-useful and can be used as revenue-generating research products.

In contrast to more traditional cell therapy methods this technology does not require the use of viruses or chemicals, and has the potential to produce safe therapeutic cells from stem cells. In addition, the TTF proteins are naturally eliminated by the cells when no longer required, a characteristic that further improves safety. The Company intends that this technology, once perfected, will first be used to create revenue-generating research products for sale through Lifeline Cell Technologys international distribution channels to the academic, biotechnology and pharmaceutical markets for cellular proteins, including the quickly growing markets for the study of stem cell biology and drug testing.

According to Jeffrey Janus, Lifeline Cell Technologys CEO, These proteins can be sold into the market for cellular proteins which exceeds $700 million and represents an excellent opportunity for LCT to grow sales. Since the technology also has broad application in research and therapy, it should provide ISCO with future out-licensing opportunities to the biotechnology and pharmaceutical industries.

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 (www.lifelinecelltech.com), 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 products, 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, 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 Scientists Create New Protein-Based Stem Cell Technology

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), announced today it has received consent from New Zealand to market its first-in-class stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. With this decision New Zealand joins Canada, which last month became the worlds first internationally recognized regulatory authority to grant approval to a stem cell drug. Prochymal is also the first therapy approved for GvHD - a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

"With each of our approvals it becomes clearer that the time for life-saving stem cell therapies in the practice of medicine has arrived, and we are humbled to have a leading role, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. I would like to thank the professionals at Medsafe for their thoughtful and expeditious review of this complex application. I would also like to thank the team at Osiris that continues to do an outstanding job of making Prochymal available to children around the world suffering from the devastating effects of GvHD."

Osiris submitted a New Medicine Application (NMA) to Medsafe(New Zealand's medical regulatory agency) in May of 2011, and was granted Priority Review in June of 2011. Priority review provides expedited review for new drugs which offer a significant clinical advantage over current treatment options. Prochymal was granted provisional consent under Section 23 of the Medicines Act 1981.

"The incidence of GvHD is likely to rise as the demographic profile of our transplant population evolves," said Hans Klingemann, M.D., Ph.D., a Professor of Medicine and the Director of the Bone Marrow & Hematopoietic Stem Cell Transplant Program at Tufts University School of Medicine. "Effective strategies to manage the often lethal consequences of GvHD reduce the overall risk to transplantation and provide the transplant physician with better options when approaching their most difficult cases.

Clinical trials have shown that Prochymal is able to induce an objective, clinically meaningful response in 61-64 percent of children with GvHD that is otherwise refractory to treatment. Furthermore, treatment response with Prochymal resulted in a statistically significant improvement in survival.

As a mother who watched my son Christian suffer and die from the horrifying effects of GvHD, while waiting for the regulatory approvals necessary to allow him access to Prochymal, words cannot express how happy I am that significant progress is finally being made, said Sandy Barker, President and Co-founder of the Gold Rush Cure Foundation. We are proud to stand side-by-side with Osiris in this historic battle for our children around the world. Our motto is 'not one more child, not one more family' and when it comes to GvHD mortality, zero is the only acceptable number.

Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries including the United States under an Expanded Access Program (EAP). It is expected that Prochymal will be commercially available in New Zealand later this year.

About GvHD

GvHD represents a major unmet medical need with no approved treatment until Prochymal. GvHD is the leading cause of transplant related mortality, in which immune cells contained within the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Severe GvHD can cause blistering of the skin, intestinal hemorrhage and liver failure. Severe GvHD is extremely painful and fatal in up to 80 percent of cases. Currently, steroids are used as first-line therapy with a success rate of only 30-50 percent. When steroids fail, treatment options are limited to immunosuppressive agents used off-label with little benefit and significant toxicities.

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Osiris Receives Second Approval for Life-Saving Stem Cell Drug; Prochymal Granted Marketing Consent by New Zealand