StemCell Therapy

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

The Myelin Repair Foundation (MRF) today announced the achievement of a myelin repair Phase 1 clinical trial for multiple sclerosis earlier than the foundations goal set for 2014. By establishing its Accelerated Research Collaboration (ARC) Model to advance myelin repair treatments forward into clinical trial Phase 1 within a decade, the Myelin Repair Foundation achieved this critical milestone ahead of its goal, validating the efficiency of the ARC model to speed drug development.

This Phase 1 clinical trial conducted at Cleveland Clinic will examine the efficacy of a new myelin repair therapeutic pathway with mesenchymal stem cells (MSCs), based on MRF supported research conducted by MRF Principal Investigator Dr. Robert Miller, Professor of Neurosciences and Vice President for Research & Technology Management at Case Western Reserve University. To date, half of the 24 patients planned for this initial trial have been enrolled.

Scientists hope that one day their research will reach clinical trials, and Im thrilled to achieve this milestone in my career, said Dr. Robert Miller. Without the support of Myelin Repair Foundation funding a critical component of our research that is the basis of this trial, this achievement would not have been possible. Our partnership with the Myelin Repair Foundation has helped identify new pathways to treat disease that reverses damage, ultimately accomplishing so much more than the suppression of MS symptoms.

Funded by the Myelin Repair Foundation, Dr. Millers team of scientists identified an innovative clinical pathway through mesenchymal stem cell signals that not only protect myelin, which is damaged by the autoimmune reaction in MS, but also facilitates myelin repair. Current MS drugs on the market only focus on the suppression of the immune system to protect myelin from future damage; patients have no treatment options available to repair myelin once damage occurs in MS.

Our goal to support research that would enter Phase 1 trials within a decade was deemed nearly impossible, said Scott Johnson, president and CEO of the Myelin Repair Foundation. To think we achieved this ambitious goal even earlier than we planned illustrates the effectiveness of our innovative research model that accelerates promising scientific discoveries into clinical trials. Even with this success, we refuse to rest on our laurels and will continue to progress myelin research into multiple clinical trials. We remain focused on our singular goal: To speed the development of an effective myelin repair treatment to reach patients with multiple sclerosis.

For more information about the clinical trial and enrollment, please visit http://www.clinicaltrials.gov.

About the Myelin Repair Foundation

The Myelin Repair Foundation (MRF) (http://www.myelinrepair.org) is a Silicon Valley-based, non-profit research organization focused on accelerating the discovery and development of myelin repair therapeutics for multiple sclerosis. Its Accelerated Research Collaboration (ARC) model is designed to optimize the entire process of medical research, drug development and the delivery of patient treatments.

About Case Western Reserve University

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The Myelin Repair Foundation Achieves Phase 1 Myelin Repair Clinical Trial

Featured Article Academic Journal Main Category: Bones / Orthopedics Also Included In: Stem Cell Research Article Date: 14 Jun 2012 - 4:00 PDT

Current ratings for: 'Fat Stem Cells Grow Bone Faster And Better'

They write about their work in the 11 June online first issue of a paper published in the new peer-reviewed journal Stem Cells Translational Medicine, which aims to span stem cell research and clinical trials.

The two co-senior authors of the study are Chia Soo, vice chair for research at University of California - Lost Angeles (UCLA) Plastic and Reconstructive Surgery, and Bruno Pault, professor of Orthopedic Surgery at UCLA. Both are members of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA.

Soo told the press that fat tissue is considered a good source of mesenchymal stem cells, the sort that can be coaxed to form various tissue types such as bone, cartilage and muscle, because there is plenty of it and it is easy to get hold of with procedures like liposuction.

One conventional method of growing these stem cells from fat tissue relies on culturing the fat cells for weeks to isolate the stem cells that form bone. These processes can increase the risk of infection and lead to genetic instability.

Another traditional method, called stromal vascular fraction (SVF), uses fresh, non-cultured cells, but it is not easy to extract SVF cells from fat tissue because there are many kinds of them, not all capabale of forming bone.

For this study, the researchers isolated and purified human perivascular stem cells (hPSC) from fat tissue, and using lab animals, showed these cells are a better option for making bone than SVF cells.

They also showed that a growth factor called NELL-1, speeded up bone formation.

Soo told the press:

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Fat Stem Cells Grow Bone Faster And Better

Stem cells are touted as a future source to replenish damaged tissue Researchers find skeletal muscle stem cells can survive for 17 days in human and 16 days in mice This is some two weeks more than the one or two days currently thought 'Highly promising' research requires more testing and validation before it can be tested in humans

By Graham Smith

PUBLISHED: 07:51 EST, 13 June 2012 | UPDATED: 07:52 EST, 13 June 2012

Some stem cells can lay dormant for more than two weeks in a dead person and then be revived to divide into new, functioning cells, scientists revealed yesterday.

The research unlocks further knowledge about the versatility of these cells, touted as a future source to replenish damaged tissue.

The scientists, led by Fabrice Chretien of the Pasteur Institute in Paris, said in a statement: 'Remarkably, skeletal muscle stem cells can survive for 17 days in humans and 16 days in mice post-mortem, well beyond the one to two days currently thought.'

Breakthrough: A fusion of several stem cells - or a myotube - obtained in vitro from a human muscle collected 17 days after an individual's death

The stem cells retained their ability to differentiate into perfectly functioning muscle cells, they found.

The researchers added: 'This discovery could form the basis of a new source, and more importantly new methods of conservation, for stem cells used to treat a number of pathologies.'

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Could dead bodies soon be harvested for their stem cells? Scientists find 'miracle' cells stay alive for 17 days in ...

(CBS News) A 10-year-old girl made medical history when a vein created from her own stem cells was transplanted into her body to treat a life-threatening blockage.

PICTURES: First lab-grown windpipe saves cancer patient

The girl had a condition called hepatic portal vein obstruction in which there is a blockage in the vein that drains blood from the intestines and spleen to the liver. A blockage here can lead to major complications like bleeding, developmental delays, an enlarged spleen and even death. Typical treatments include removing veins from other parts of the body - such as the leg - and transplanting them elsewhere to restore blood flow, but the procedures can be risky and have had mixed success.

For the new procedure, the girl was admitted to the Sahlgrenska University Hospital in Gothenburg, Sweden, where a team had already taken a 9 centimeter segment of vein from the groin of a deceased donor. The doctors stripped all cells from the vein, leaving just a tube of scaffolding, which was then injected with stem cells obtained from the girl's own bone marrow. After two weeks in a bioreactor, the graft was re-implanted in the 10-year-old girl, and her condition has been improving ever since.

The medical milestone is described in the June 14 issue of the The Lancet.

"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 transplant, explained Dr. Martin Birchall, chair of laryngology, and Dr. George Hamilton, professor of vascular surgery, both at the University College London, U.K., in a commentary published in the same issue.

The girl had no complications from the operation and her blood flow was restored immediately.

In the year since the procedure, the girl has grown from about 4 feet 4.5 inches to almost 4 feet 7 inches and her weight increased from 66 pounds to 77 pounds. However over that year her blood flow decreased and the graft narrowed, requiring a second stem cell-based procedure. She has remained well since the second procedure, taking long walks of up to two miles and participating in light gymnastics. Especially noteworthy is her immune system has not attempted to fight off the donor tissue, despite her not taking any immunosuppressive drugs which often carry side effects.

"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," wrote the surgeons, led by Dr. Michael Olausson, a profsesory of surgery at the University of Gothenburg in Sweden. They added that their work opens up the possibility of trying to reproduce arteries for surgical use, such as for coronary bypass surgery.

This isn't the first procedure to use a patient's stem cells to create new tissue to save a person's life. HealthPop reported in 2011 of an Eritrean man with late-stage throat cancer who received the world's first synthetic windpipe. The organ was grown from the man's stem cells and then applied to a plastic scaffold, eliminating the need for a donor organ.

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10-year-old girl gets new vein made from her own stem cells in medical first

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.

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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.

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Girl gets vein grown from her own stem cells for transplant

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Posted June 14, 2012

COLUMBIA, Md. --Osiris Therapeutics, Inc.(NASDAQ: OSIR) 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. New Zealand joins Canada, which last month became the world's 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," saidC. 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 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," saidHans 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," saidSandy 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.

Osiris Therapeutics, Inc. is a stem cell company, having developed the world's first approved stem cell drug, Prochymal. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 48 U.S. and 144 foreign issued patents.

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Osiris Receives Second Approval for Stem Cell Drug

ReNeuron Group (Berlin: RQE.BE - news) plc

(the "Company")

Interim data from clinical trial of ReNeuron's stem cell therapy for stroke to be presented at leading scientific conference

Data show no safety concerns and evidence of sustained reductions in neurological impairment and spasticity

Guildford, UK, 14 June 2012: ReNeuron Group plc (the "Company") (LSE: RENE.L) is pleased to announce the presentation of interim data from the PISCES (Pilot Investigation of Stem Cells in Stroke) clinical trial of its ReN001 stem cell therapy for disabled stroke patients. In this open label, dose-ranging Phase I safety study, ReNeuron's ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.

The primary aim of the study is to test the safety and tolerability of the treatment in ascending doses of the ReN001 cells, in patients with moderate to severe functional neurological impairments resulting from their stroke. The secondary aim of the study is to evaluate efficacy measures for the design of future clinical trials with ReN001, including imaging measures as well as a number of tests of sensory, motor and cognitive functions.

To date, six patients have been treated in the PISCES stroke study, representing the first two of four dose cohorts. The interim data being presented are from the first five patients treated, at 2 x 12 month, 1 x six month and 2 x three month follow-up points.

No cell-related adverse events or adverse immune-related responses were reported in any of the patients treated to date. A number of the patients experienced minor procedure-related adverse events such as asymptomatic bleeds or superficial scalp infections at the implantation wound site.

Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.

Neurological deficits were measured using the National Institutes of Health Stroke Scale (NIHSS), a higher score representing a worse deficit. Patients are required to have a NIHSS score of at least 6 to participate in the study. The pre-treatment median score for the first five patients was 8 (range 6 to 10) and the three month post-treatment median score was 4 (range 3 to 9).

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ReNeuron Group plc - PISCES Trial Interim Data

14 June 2012 Last updated at 07:25 ET By Eleanor Bradford BBC Scotland Health Correspondent

The first patients to take part in a clinical trial of a stem cell treatment for stroke have seen reductions in their disability, according to doctors.

Six patients in the west of Scotland had human stem cells inserted close to the damaged part of their brain.

After receiving the treatment, they saw improvements in the limb weakness they suffered as a result of their stroke.

Howeve, doctors have cautioned against reading too much into the early results of the clinical trial.

It is the world's first trial of a neural stem cell therapy for stroke.

Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.

The trial is being conducted at the Institute of Neurological Sciences at the Southern General Hospital in Glasgow, and is being led by Glasgow University neurologist Professor Keith Muir.

He said: "So far we've seen no evidence of any harmful effects. We're dealing with a group of people a long time after a stroke with significant disability and we don't really expect these patients to show any change over time.

"So it's interesting to see that in all the patients so far they have improved slightly over the course of their involvement in the study."

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Stem cells 'help' stroke patients

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

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

By Makiko Kitamura - 2012-06-13T22:30:00Z

The first vein grown from a patients own stem cells was successfully transplanted into a 10-year-old girl, potentially offering a way for those lacking healthy veins to undergo dialysis or heart bypass surgery.

A team led by Michael Olausson of the University of Gothenburg took a 9-centimeter (3.5-inch) segment of vein from a human donor and removed all living cells, the Swedish researchers wrote in a study in The Lancet medical journal today. The resulting protein scaffolding was injected with stem cells from the girls bone marrow, and two weeks later was implanted in the patient, who had a blockage in the vein that carries blood from the spleen and intestines to the liver.

The result points to what may be a safer source of stem cells, the building blocks of life which can grow into any type of tissue in the body. Using cells from the patient may limit the risk that the immune system would attack the transplant, which can occur with tissue taken from healthy people and given to the sick. The girl hasnt developed signs of rejection, even without taking drugs to suppress her immune system, the researchers said.

The successful procedure establishes the feasibility and safety of a novel paradigm for treatment, the researchers wrote in the study. Our work opens interesting new areas of research, including trying to reproduce arteries for surgical use in patients.

The recipient had no complications from the operation, and a year later, has grown 6 centimeters and gained 5 kilograms (11 pounds) in weight.

Olausson and colleagues report suggests that tissue- engineered vascular grafts are promising, but one-off experiences such as the procedure they describe need to be converted into full clinical trials in key target populations, Martin Birchall and George Hamilton, professors at the University College London, wrote in a commentary accompanying the Lancet publication.

The study was funded by the Swedish government.

To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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First Vein Grown From Human Stem Cells Transplanted

13 June 2012 Last updated at 08:31 ET

Japanese stem cell scientist Dr Shinya Yamanaka has been awarded the Millennium Technology Prize.

His award is for discovering how to reprogram human cells to mimic embryonic stem cells, which can become any cell in the body.

Called induced pluripotent stem (iPS) cells, these now aid research into regenerative medicine.

He was joint-winner with Linus Torvalds, who created a new open source operating system for computers.

This is the first time the prize has been shared by two scientists - they will split the 1.2m euros ($1.3m; 800,000) award.

My goals over the decade include to develop new drugs to treat intractable diseases by using iPS cell technology and to conduct clinical trials using it on a few patients with Parkinson's diseases, diabetes or blood diseases.

The President of the Republic of Finland, Sauli Niinisto, presented the prize at the Finnish National Opera in Helsinki.

Dr Ainomija Haarla, President of Technology Academy Finland - the foundation which awards the prize every two years - said: "The International Selection Committee has to judge whether an innovation has had a favourable impact on people's lives and assess its potential for further development to benefit humanity in the future.

"The innovations of both this year's winners embody that principle.

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Stem cell scientist wins award

ScienceDaily (June 13, 2012) Human-derived stem cells can spontaneously form the tissue that develops into the part of the eye that allows us to see, according to a study published by Cell Press in the 5th anniversary issue of the journal Cell Stem Cell. Transplantation of this 3D tissue in the future could help patients with visual impairments see clearly.

"This is an important milestone for a new generation of regenerative medicine," says senior study author Yoshiki Sasai of the RIKEN Center for Developmental Biology. "Our approach opens a new avenue to the use of human stem cell-derived complex tissues for therapy, as well as for other medical studies related to pathogenesis and drug discovery."

During development, light-sensitive tissue lining the back of the eye, called the retina, forms from a structure known as the optic cup. In the new study, this structure spontaneously emerged from human embryonic stem cells (hESCs) -- cells derived from human embryos that are capable of developing into a variety of tissues -- thanks to the cell culture methods optimized by Sasai and his team.

The hESC-derived cells formed the correct 3D shape and the two layers of the optic cup, including a layer containing a large number of light-responsive cells called photoreceptors. Because retinal degeneration primarily results from damage to these cells, the hESC-derived tissue could be ideal transplantation material.

Beyond the clinical implications, the study will likely accelerate the acquisition of knowledge in the field of developmental biology. For instance, the hESC-derived optic cup is much larger than the optic cup that Sasai and collaborators previously derived from mouse embryonic stem cells, suggesting that these cells contain innate species-specific instructions for building this eye structure. "This study opens the door to understanding human-specific aspects of eye development that researchers were not able to investigate before," Sasai says.

The anniversary issue containing Sasai's study will be given to each delegate attending the 2012 ISSCR meeting in Yokohama, Japan. To highlight the ISSCR meeting and showcase the strong advances made by Japanese scientists in the stem cell field, the issue will also feature two other papers from Japanese authors, including the research groups of Akira Onishi and Jun Yamashita. In addition, the issue contains a series of reviews and perspectives from worldwide leaders in stem cell research.

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The above story is reprinted from materials provided by Cell Press, via EurekAlert!, a service of AAAS.

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Scientists see new hope for restoring vision with stem cell help

LONDONFor 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-centimeter (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 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.

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Doctors make new vein with girl's own stem cells

Nation & World briefing

LONDON -- For the first time doctors have successfully transplanted a vein grown with a patient's own stem cells in another example of 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. In 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 31/2-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 girl's bone marrow, scientists grew millions of cells to cover the vein, a two-week process. 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.

Suchitra Sumitran-Holgersson of the University of Gothenburg, one of the study's authors, and her colleagues published the results of their work online Thursday, June 14, in the British medical journal Lancet. The work was paid for by the Swedish government.

Bishops continue to fight mandate

ATLANTA -- The nation's Roman Catholic bishops on Wednesday promised steadfast opposition to President Barack Obama's mandate that birth control be covered by health insurance, saying it is one

Bishops insisted repeatedly that they had no partisan agenda. They said they were forced into action by state and federal policies that they said would require them to violate their beliefs in order to maintain the vast public-service network the church has built over a century or longer.

"It is not about parties, candidates or elections as others have suggested," said Baltimore Archbishop William Lori, chairman of the bishops' religious-liberty committee. "The government chose to pick a fight with us."

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Vein grown with patient's stem cells is transplanted

Salk researcher's findings suggest a potentially favorable time to harvest stem cells for therapy and may reveal genes crucial to tissue production

LA JOLLA, CA----With their potential to treat a wide range of diseases and uncover fundamental processes that lead to those diseases, embryonic stem (ES) cells hold great promise for biomedical science. A number of hurdles, both scientific and non-scientific, however, have precluded scientists from reaching the holy grail of using these special cells to treat heart disease, diabetes, Alzheimer's and other diseases.

In a paper published June 13 in Nature, scientists at the Salk Institute for Biological Studies report discovering that ES cells cycle in and out of a "magical state" in the early stages of embryo development, during which a battery of genes essential for cell potency (the ability of a generic cell to differentiate, or develop, into a cell with specialized functions) is activated. This unique condition, called totipotency, gives ES cells their unique ability to turn into any cell type in the body, thus making them attractive therapeutic targets.

"These findings," says senior author Samuel L. Pfaff, a professor in Salk's Gene Expression Laboratory, "give new insight into the network of genes important to the developmental potential of cells. We've identified a mechanism that resets embryonic stem cells to a more youthful state, where they are more plastic and therefore potentially more useful in therapeutics against disease, injury and aging."

ES cells are like silly putty that can be induced, under the right circumstances, to become specialized cells-for example, skin cells or pancreatic cells-in the body. In the initial stages of development, when an embryo contains as few as five to eight cells, the stem cells are totipotent and can develop into any cell type. After three to five days, the embryo develops into a ball of cells called a blastocyst. At this stage, the stem cells are pluripotent, meaning they can develop into almost any cell type. In order for cells to differentiate, specific genes within the cells must be turned on.

Pfaff and his colleagues performed RNA sequencing (a new technology derived from genome-sequencing to monitor what genes are active) on immature mouse egg cells, called oocytes, and two-cell-stage embryos to identify genes that are turned on just prior to and immediately following fertilization. Pfaff's team discovered a sequence of genes tied to this privileged state of totipotency and noticed that the genes were activated by retroviruses adjacent to the stem cells.

Nearly 8 percent of the human genome is made up of ancient relics of viral infections that occurred in our ancestors, which have been passed from generation to generation but are unable to produce infections. Pfaff and his collaborators found that cells have used some of these viruses as a tool to regulate the on-off switches for their own genes. "Evolution has said, 'We'll make lemonade out of lemons, and use these viruses to our advantage,'" Pfaff says. Using the remains of ancient viruses to turn on hundreds of genes at a specific moment of time in early embryo development gives cells the ability to turn into any type of tissue in the body.

From their observations, the Salk scientists say these viruses are very tightly controlled-they don't know why-and active only during a short window during embryonic development. The researchers identified ES cells in early embryogenesis and then further developed the embryos and cultured them in a laboratory dish. They found that a rare group of special ES cells activated the viral genes, distinguishing them from other ES cells in the dish. By using the retroviruses to their advantage, Pfaff says, these rare cells reverted to a more plastic, youthful state and thus had greater developmental potential.

Pfaff's team also discovered that nearly all ES cells cycle in and out of this privileged form, a feature of ES cells that has been underappreciated by the scientific community, says first author Todd S. Macfarlan, a former postdoctoral researcher in Pfaff's lab who recently accepted a faculty position at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. "If this cycle is prevented from happening," he says, "the full range of cell potential seems to be limited."

It is too early to tell if this "magical state" is an opportune time to harvest ES cells for therapeutic purposes. But, Pfaff adds, by forcing cells into this privileged status, scientists might be able to identify genes to assist in expanding the types of tissue that can be produced.

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"Magical State" of Embryonic Stem Cells May Help Overcome Hurdles to Therapeutics

News

Article date: February 27, 2012

By Stacy Simon

Someone being treated for cancer often needs a lot of help at home, too. Usually a spouse, partner, adult child, or close friend becomes the primary caregiver who provides transportation, keeps house, prepares meals, provides emotional support, and communicates with other relatives and friends. The caregiver may also help feed, dress and bathe the patient, give drugs, manage side effects, report problems, and manage financial and insurance issues.

The physical and emotional toll of these tasks often leads to a lot of stress and a negative impact on the caregivers own health. In fact, the level of distress for the caregiver can sometimes be as high as it is for the patient. Caregivers have less time for their own needs, and often spend less time on leisure activities, have less contact with family and friends, dont get as much sleep or exercise, and ignore their own physical health concerns.

There may also be a financial impact. Caregivers may work fewer hours, take a leave of absence, or move closer to the patient.

Researchers from the National Institutes of Health say health care providers should devote some attention to caregivers, in addition to the patients theyre caring for, to help relieve some of this burden. The researchers detailed the case of one caregiver in a recent article published in the Journal of the American Medical Association.

The caregiver was a 53-year-old woman whose husband had an aggressive bone marrow cancer called acute myeloid leukemia. He was hospitalized to undergo a stem cell transplant, a complicated procedure that can often have major side effects. His hospital stay and recovery was prolonged because of complications that included fluid around the heart, kidney failure, pneumonia, and graft vs. host disease. During the next several weeks, he was readmitted twice for additional complications including heart failure. He died during his last hospital stay.

During the time she cared for her husband, the wife, like many caregivers, complained little to the health care team, not wanting to take the focus away from the person being cared for. But when asked, she reported symptoms of stress that included anxiety, depression, loneliness, emotional distress, fatigue, lack of energy, trouble sleeping, and difficulty staying focused. Financial concerns added to her stress level. The transplant center was 143 miles away, so the couple had to move into temporary housing near the center. Both were unemployed due to disability, yet she was also supporting her father, mother and aunt.

The stresses associated with caregiving can increase the risk of illness in the caregiver. And like many caregivers, the wife in the case study already had a history of health problems and was dealing with additional stressful events. She had had heart bypass surgery and arthritis, and she was a smoker. Four months after her husbands death, her father died. Shortly after that, she had a heart attack and needed a pacemaker.

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Case Study: When You Care for Someone with Cancer

Last year Peyton Manning flew to Europe on a private jet, not for tea and crumpets or to see the Louvre, but for an experimental stem-cell treatment on his injured neck.

The procedure, one that isn't even legal in the United States, allegedly took his own fat cells and used them to try to regrow damaged neck tissue:

"There are many proposed therapies that are being tested in clinical trials, and there are more to come," Dr. Lawrence Goldstein, director of the stem cell program at the University of California, San Diego, told ABC News. "But in the absence of reliable evidence, it is impossible to know whether the 'treatment' will make Manning better or worse or merely financially poorer."

TheNFL doesn't have any rules specifically banning illegal procedures that an athlete can have done in foreign locales. Kobe Bryant, the NBA's aging lion, had similarly cutting-edge treatment on his arthritic knee in Germany. It's called "Biologic Medicine,"and in addition to Bryant, super-agent Ari Emanueland the late Pope John Paul II were ardent believers.

There are a ton of controversial treatments possible where science collides with loose regulation. Bone marrow injections filled with those miracle-working stem cells can be injected into the body. Blood can be heated up, spun and spun in an incubator, the healing agents isolated and injected. The 34-year-old Bryant felt like a new man after first undergoing the procedure, like Manning's one not approved by the FDA:

He even recommended the treatment to Alex Rodriguez, which led the baseball star to undergo the same treatment on his knee late last year. Bryant hasn't commented publicly on the treatment, but A-Rod has described the feelings of his friend.

Bryant "was really adamant about how great the procedure was for him," Rodriguez told reporters."I know that he was hurting before, almost even thinking about retirement, that's how much pain he was under. And then he said after he went to Germany he felt like a 27-year-old again. I was still a little apprehensive about it, and he kept staying on me about it."

Athletes at the highest levels will do almost anything to maintain that edgeto feel younger, sprier and as explosive as they did in their primes. And with the right money and resources, they are extending their careers further than any of their predecessors would have dared dream. Is it any wonder athletes in mixed martial arts are doing the same?

Frank Mir on TRT

In that sport, some of the UFC's top aging stars have undergone Testosterone Replacement Therapy (TRT), looking to bring their bodies' natural level of testosterone back to the levels they enjoyed in their 20s. Top contenders like Dan Henderson (41), Chael Sonnen (35) and Frank Mir (33)have all undergone the procedure. Former middleweight champion Rich Franklin (37)is considering it.

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The UFC's Supposed Testosterone Epidemic: Critics Living in the Past

The proposed new platform for the Republican Party of Iowa touches on abortion, agriculture, budgeting, business, criminal justice, education, elections, energy, environment, family values, foreign policy, government, gun rights, health care, homeland security, human services, immigration, marriage, religious freedom, the Republican Party, right to work, taxation and transportation.

Iowa Gov. Terry Branstad said most people dont read the platform, which is controlled by the most ardent activists. The candidates stances are more important, he said.

At the end of the day, the platform is a grassroots a document as developed by the delegates, Branstad told the Des Moines Register Tuesday. But whats more important, in my mind, is the candidates that really articulate their stand on the issues. Thats really the important thing and thats what goes to the voters. Most people dont read the party platforms and you can take either party platform and you find that parties tend to be controlled by the more ardent left or right and that doesnt really reflect where the candidates are going to come down.

Heres the proposed 2012 platform, which delegates will vote on Saturday during the state convention in downtown Des Moines:

Preamble: We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable rights, that among these are life, liberty, and the pursuit of happiness. That to secure these rights, governments are instituted among men, deriving their just powers from the consent of the governed. That whenever any form of government becomes destructive of these ends, it is the right of the people to alter or to abolish it, and to institute new government, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their safety and happiness.

As Republicans, we seek a world of liberty; a world in which all individuals are sovereign over their own lives and are never deprived of property or forced to sacrifice ones values for the benefit of others. We believe that respect for individual rights is the essential precondition for a free and prosperous world, and that only through freedom can peace and prosperity be realized. Consequently, we defend each persons right to engage in any activity that is peaceful and honest, and welcome the diversity that freedom brings. We defend the right of each individual to be free and to follow their own dreams in their own ways, unless the exercise of their freedoms infringes upon the valid rights of others.

In the following pages we have set forth our basic principles and enumerated various policies derived from those principles. Let it be clear that these specific policies are not our end goal. Our goal is nothing more nor less than a world set free, and it is to this end that we stand together.

Where two planks might seem to be contradictory, the platform should be interpreted as favoring the goal of the plan providing the least government while protecting basic rights and responsibilities of individuals. Some planks may appear redundant or in conflict, but upon closer evaluation you should see that sufficient nuance exists to include each plank. Any redundancy from one section of this Platform to another was deliberately adopted for emphasis and because government actions often impact more than one area of life. All planks should be read and understood in the context of related issues, events, and circumstances.

Other planks are supported as possible steps toward the goal of limited, responsible, Constitutional, Republican Government. It has taken many years to move away from Constitutional Government and it is unlikely that we will be able to return to the vision of our illustrious Founding Fathers overnight.

A Right to Life 1.1 We believe in the sacred gift of life from conception to natural death. On day one a babys genetic code and DNA are formed. That is the beginning of life. We affirm that the unborn child is a living human being, with rights separate from those of its mother regardless of gestational age or dependency. 1.2 We oppose infanticide, euthanasia, and assisted suicide. 1.3 We advocate the appointment of judges who respect the sanctity of life and who understand their limited role in government. 1.4 We disagree with Roe vs. Wade and Doe vs. Bolton as settled law. Under the Tenth amendment, these Supreme Court decisions have no authority over the states. 1.5 We support a personhood amendment to the US Constitution that states, Personhood and life begins at Conception and that no person shall be deprived of life, liberty, and property, according to the 14th amendment with-out due Process of Law and shall hold all officials accountable to enforce it. 1.6 We oppose the use of public revenues for abortion, and call for elimination of government funding for all organizations, such as Planned Parenthood, which advocate or support abortion. 1.7 We support a ban of RU-486 (morning after pill) and all abortion-inducing drugs. 1.8 We support legislation requiring a parent or legal guardians consent before an abortion or any reproductive surgery is performed on a minor child. 1.9 We believe in conscience-clause legislation so that no physician, pharmacist, or other health care provider can be penalized for refusing to prescribe, dispense, or participate in the procurement of abortion or anything contrary to the conscience of the health care provider. 1.10 We support an Iowa Womans Right to Know Law requiring informed consent including a three day waiting period with a mandatory ultrasound before any elective abortion services may be provided. Informed Consent means that abortionists must offer to the pregnant woman, prior to the abortion, complete factual information about the complications of abortion, the biological development of the unborn, fetal pain, and the availability of alternatives to abortion. 1.11 We call for confidential statistical reporting of abortion procedures to the State Health Department by all doctors and health facilities performing abortions. 1.12 Facilities performing abortions should be subject to the same health and safety standards as hospitals. 1.13 We call for the end of tele-med abortions. 1.14 We support legislation that would prohibit organizations, such as Planned Parenthood, from entering public school facilities for the purpose of promoting abortion. 1.15 We call for banning partial birth abortions. 1.16 We support agencies that do not refer for or perform abortions and encourage Positive Alternatives, for pregnancy counseling. We support adoption and aid to unwed mothers during pregnancy. All funding must come from the private sector. 1.17 We support the use of non-embryonic stem cells to advance modern medical research. We oppose somatic cell nuclear transfer (human cloning), embryonic stem cell research, human fetal-tissue research from induced abortions, and the commercial use or sale of fetal parts. 1.18 We oppose the selling, brokering, or marketing of fetal and aborted tissue. We oppose the use of aborted fetal tissue in vaccines. This should be illegal.

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Iowa governor downplays GOP party platform; here's the whole document

Ethical, Clinical and Commercial Issues to be Navigated before Full Potential of Stem Cell Therapies can be Unleashed

LONDON, June 13, 2012 /PRNewswire-Asia/ -- Stem cells offer exciting potential in regenerative medicine, and are likely to be widely used by mid-2017. Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research.

New analysis from Frost & Sullivan (http://www.pharma.frost.com), Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics, finds that the market will be driven by stem cell applications in drug discovery platforms and by successful academia commercial company partnership models.

"The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase," notes Frost & Sullivan Consulting Analyst Vinod Jyothikumar. "Previously, animal cell lines, tumours, or genetic transformation have been the traditional platform for testing drug candidates; however, these 'abnormal' cells have significantly contributed to a lack of translation into clinical studies."

Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research. This will provide impetus to the emergence of novel cell-based therapies.

Key challenges to market development relate to reimbursement, ethics and the complexity of clinical trials.

Securing reimbursement for stem cell therapeutic products is expected to be critical for commercial success. However, stem cell therapies are likely to be expensive. Insurers, therefore, may be unwilling to pay for the treatment. At the same time, patients are unlikely to be able to afford these treatments.

"The use of embryonic stem cells raises a host of thorny ethical, legal, and social issues," adds Jyothikumar. "As a result, market prices for various products may be affected."

Moreover, many research institutes are adopting policies promoting the ethical use of human embryonic tissues. Such policies are hindering the overall research process for several companies working in collaboration with these institutes.

"In addition to apprehensions about how many products will actually make it through human-based clinical trials, companies are also worried about which financial model can be applied to stem cell therapies," cautions Jyothikumar. "Possibly low return on investment (ROI) is also resulting in pharmaceutical companies adopting a cautious approach to stem cell therapeutics."

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New Applications in Drug Discovery Platforms to Fuel Advance of Stem Cells, Says Frost & Sullivan