Life created for first time from eggs made from skin cells
By LizaAVILA
London, October 5 (ANI): Using stem cells made from skin, a Japanese team has created healthy eggs that, once fertilised, grow into normal baby mice.
These babies later had their own babies, the BBC reported.
The team at Kyoto University used stem cells from two sources: those collected from an embryo and skin-like cells, which were reprogrammed, into becoming stem cells.
The first step was to turn the stem cells into early versions of eggs.
A "reconstituted ovary" was then built by surrounding the early eggs with other types of supporting cells that are normally found in an ovary. This was transplanted into female mice. Surrounding the eggs in this environment helped them to mature.
IVF techniques were used to collect the eggs, fertilise them with sperm from a male mouse and implant the fertilised egg into a surrogate mother.
"They develop to be healthy and fertile offspring," Dr Katsuhiko Hayashi, from Kyoto University, told the BBC.
Those babies then had babies of their own, whose "grandmother" was a cell in a laboratory dish.
If the same methods could be used in people then, it could help infertile couples have children and even allow women to overcome the menopause.
But experts say many scientific and ethical hurdles must be overcome before the technique could be adapted for people.
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Life created for first time from eggs made from skin cells
Robin Roberts says her prayers have been answered as she recovers from bone marrow transplant
By LizaAVILA
By Daily Mail Reporter
PUBLISHED: 14:58 EST, 4 October 2012 | UPDATED: 16:07 EST, 4 October 2012
Good Morning America co-anchor Robin Roberts has revealed that her bone marrow transplant, which she underwent two weeks ago, appears to have been successful.
The procedure, which saw donor stem cells from her sister Sally Ann injected into her body, took just five minutes, and according to the 51-year-old, who wrote fans an update from her hospital in New York City this morning, her sister's cells 'feel right at home' in her body.
'My blood counts are GREAT,' she wrote on herGMA blog, after being hospitalized or 25 days now. 'It's an answer to so many prayers'.
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Pulling through: Robin Roberts, 51, said her friends near and far (pictured here with Sam and Josh yesterday) have been lifting her spirits, she says
Ms Roberts, who was diagnosed with myelodysplastic syndrome, or MDS, earlier this year - a disease which attacks blood cells and bone - added: 'My doctors and rock star nurses are very pleased with my progress and I could not be more thankful for the excellent care I am receiving.
'I have had some extremely painful days and its still difficult for me to eat because of all the chemo. [But] I continue to learn so much on this journey, especially when it comes to true friendship and love.
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Robin Roberts says her prayers have been answered as she recovers from bone marrow transplant
Cedars-Sinai study sheds light on bone marrow stem cell therapy for pancreatic recovery
By LizaAVILA
Public release date: 2-Oct-2012 [ | E-mail | Share ]
Contact: Sandy Van sandy@prpacific.com 808-526-1708 Cedars-Sinai Medical Center
LOS ANGELES (Oct. 2, 2012) Researchers at Cedars-Sinai's Maxine Dunitz Neurosurgical Institute have found that a blood vessel-building gene boosts the ability of human bone marrow stem cells to sustain pancreatic recovery in a laboratory mouse model of insulin-dependent diabetes.
The findings, published in a PLOS ONE article of the Public Library of Science, offer new insights on mechanisms involved in regeneration of insulin-producing cells and provide new evidence that a diabetic's own bone marrow one day may be a source of treatment.
Scientists began studying bone marrow-derived stem cells for pancreatic regeneration a decade ago. Recent studies involving several pancreas-related genes and delivery methods transplantation into the organ or injection into the blood have shown that bone marrow stem cell therapy could reverse or improve diabetes in some laboratory mice. But little has been known about how stem cells affect beta cells pancreas cells that produce insulin or how scientists could promote sustained beta cell renewal and insulin production.
When the Cedars-Sinai researchers modified bone marrow stem cells to express a certain gene (vascular endothelial growth factor, or VEGF), pancreatic recovery was sustained as mouse pancreases were able to generate new beta cells. The VEGF-modified stem cells promoted growth of needed blood vessels and supported activation of genes involved in insulin production. Bone marrow stem cells modified with a different gene, PDX1, which is important in the development and maintenance of beta cells, resulted in temporary but not sustained beta cell recovery.
"Our study is the first to show that VEGF contributes to revascularization and recovery after pancreatic injury. It demonstrates the possible clinical benefits of using bone marrow-derived stem cells, modified to express that gene, for the treatment of insulin-dependent diabetes," said John S. Yu, MD, professor and vice chair of the Department of Neurosurgery at Cedars-Sinai, senior author of the journal article.
Diabetes was reversed in five of nine mice treated with the injection of VEGF-modified cells, and near-normal blood sugar levels were maintained through the remainder of the six-week study period. The other four mice survived and gained weight, suggesting treatment was beneficial even when it did not prompt complete reversal. Lab studies later confirmed that genetically-modified cells survived and grew in the pancreas and supported the repopulation of blood vessels and beta cells.
Anna Milanesi, MD, PhD, working in Yu's lab as an endocrinology fellow, is the article's first author. The researchers cautioned that although this and other related studies help scientists gain a better understanding of the processes and pathways involved in pancreatic regeneration, more research is needed before human clinical trials can begin.
Insulin-dependent diabetes occurs when beta cells of the pancreas fail to produce insulin, a hormone that regulates sugar in the blood. Patients must take insulin injections or consider transplantation of a whole pancreas or parts of the pancreas that make insulin, but transplantation carries the risk of cell rejection.
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Cedars-Sinai study sheds light on bone marrow stem cell therapy for pancreatic recovery
Blind Mice Get Experimental Stem Cell Treatment For Blindness
By LizaAVILA
April Flowers for redOrbit.com Your Universe Online
Columbia University ophthalmologists and stem cell researchers have developed an experimental treatment for blindness using the patients skin cells, which has improved the vision of blind mice in testing.
The findings of this research, published online in the journal Molecular Medicine, suggest that induced pluripotent stem cells (iPS) could soon be used to improve vision in people with macular degeneration and other eye retina diseases. iPS cells are derived from adult human skin cells but have embryonic qualities.
With eye diseases, I think were getting close to a scenario where a patients own skin cells are used to replace retina cells destroyed by disease or degeneration, says Stephen Tsang, MD, PhD, associate professor of ophthalmology and pathology & cell biology. Its often said that iPS transplantation will be important in the practice of medicine in some distant future, but our paper suggests the future is almost here.
Scientists were very excited by the advent of human iPS cells when they were discovered in 2007, as they provide a way to avoid the ethical complications of embryonic stem cells. Another advantage is that the iPS cells are created from the patients own skin, eliminating the need for anti-rejection medications. Like the ethically challenged embryonic cells, iPS cells can develop into any type of cell. To-date, no iPS cells have been implanted into people, but many ophthalmologists say that the eye would prove to be ideal testing ground for iPS therapies.
The eye is a transparent and accessible part of the central nervous system, and thats a big advantage. We can put cells into the eye and monitor them every day with routine non-invasive clinical exams, Tsang said. And in the event of serious complications, removing the eye is not a life-threatening event.
Professor Tsang is running a new preclinical iPS study using human iPS cells derived from the skin cells of a 53-year-old donor. The cells were first transformed with a cocktail of growth factors into cells in the retina that lie underneath the eyes light-sensing cells.
Retina cells nourish the light-sensing cells and protect the fragile cells from excess light, heat and cellular debris. In macular degeneration and retinitis pigmentosa, retina cells die, which allows the photoreceptor cells to degenerate causing the patient to lose their vision. It is estimated that 30 percent of people will have some form of macular degeneration by the time they are 75 years old, as it is the leading cause of vision loss in the elderly. Currently, it affects 7 million Americans and that is expected to double by 2020.
The Columbia research team injected the iPS-derived retina cells into the right eyes of 34 mice that had a genetic mutation that caused their retina cells to degenerate. In many of the mice, the iPS cells assimilated into the retina without disruption and functioned as normal retina cells well into the animals old age. Mice in the control group, who received injections of saline or inactive cells, showed no improvement in retina tests.
Our findings provide the first evidence of life-long neuronal recovery in a preclinical model of retinal degeneration, using stem cell transplant, with vision improvement persisting through the lifespan, Tsang says. And importantly, we saw no tumors in any of the mice, which should allay one of the biggest fears people have about stem cell transplants: that they will generate tumors.
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Blind Mice Get Experimental Stem Cell Treatment For Blindness
Patients' own skin cells could restore vision in elderly with macular degeneration
By LizaAVILA
Washington, October 2 (ANI): A new study has suggested that induced pluripotent stem (iPS) cells - which are derived from adult human skin cells but have embryonic properties - could soon be used to restore vision in people with macular degeneration and other diseases that affect the eye's retina.
In the study conducted by Columbia ophthalmologists and stem cell researchers, adult stem cells developed from a patient's skin cells improved the vision of blind mice.
"With eye diseases, I think we're getting close to a scenario where a patient's own skin cells are used to replace retina cells destroyed by disease or degeneration," said the study's principal investigator, Stephen Tsang, MD, PhD, associate professor of ophthalmology and pathology and cell biology.
"It's often said that iPS transplantation will be important in the practice of medicine in some distant future, but our paper suggests the future is almost here," he stated.
The advent of human iPS cells in 2007 was greeted with excitement from scientists who hailed the development as a way to avoid the ethical complications of embryonic stem cells and create patient-specific stem cells.
Like embryonic stem cells, iPS cells can develop into any type of cell. Thousands of different iPS cell lines from patients and healthy donors have been created in the last few years, but they are almost always used in research or drug screening.
In Tsang's new preclinical iPS study, human iPS cells - derived from the skin cells of a 53-year-old donor - were first transformed with a cocktail of growth factors into cells in the retina that lie underneath the eye's light-sensing cells.
The primary job of the retina cells is to nourish the light-sensing cells and protect the fragile cells from excess light, heat, and cellular debris. If the retina cells die - which happens in macular degeneration and retinitis pigmentosa - the photoreceptor cells degenerate and the patient loses vision.
Macular degeneration is a leading cause of vision loss in the elderly, and it is estimated that 30 percent of people will have some form of macular degeneration by age 75.
In their study, the researchers injected the iPS-derived retina cells into the right eyes of 34 mice that had a genetic mutation that caused their retina cells to degenerate.
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Patients' own skin cells could restore vision in elderly with macular degeneration
StemCells, Inc. Achieves Spinal Cord Injury Milestone With First Neural Stem Cell Transplant Into Patient With Sensory …
By LizaAVILA
NEWARK, Calif., Sept. 27, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that the first patient with an incomplete spinal cord injury has been enrolled in the Company's Phase I/II clinical trial in chronic spinal cord injury and transplanted with the Company's proprietary HuCNS-SC(R) neural stem cells. The patient, a Canadian man who suffered a thoracic spinal cord injury from a sports-related accident, was administered the cells yesterday at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation. This is the first patient in the second cohort of the trial, which will be comprised of four patients who retain some sensory function below the level of trauma and are therefore considered to have an incomplete injury.
"This is an important milestone for StemCells and the spinal cord injury community as it is the first time anyone has ever transplanted neural stem cells into a patient with an incomplete injury," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "Given the encouraging interim data from the most severely injured patient cohort that we reported earlier this month, testing patients with less severe injury should afford us an even better opportunity to continue to test safety and to detect and assess clinical changes. Unlike the patients in the first cohort, patients with incomplete injuries have retained a degree of spinal cord function that might be even further augmented by transplantation with neural stem cells."
Earlier this month, the Company reported that interim six-month data from the first patient cohort in the Phase I/II clinical trial continued to demonstrate a favorable safety profile, and showed considerable gains in sensory function in two of the three patients compared to pre-transplant baselines. Patients in the first cohort all suffered a complete injury to their spinal cord, leaving them with no neurological function below the level of injury. Following transplantation with HuCNS-SC cells, there were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients were neurologically stable through the first six months after transplantation. Changes in sensitivity to touch, heat and electrical stimuli were observed in well-defined and consistent areas below the level of injury in two of the patients, while the third patient remained stable. Importantly, the changes in sensory function were confirmed objectively by measures of electrical impulse transmission across the site of injury, each of which correlated with the clinical examination.
About the Spinal Cord Injury Clinical Trial
The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC(R) purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment, and their injuries must have occurred within three to twelve months prior to transplantation of the cells. In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor function and bowel/bladder function. The Company has dosed the first patient cohort, all of whom have injuries classified as AIS A according to the American Spinal Injury Association Impairment Scale (AIS). In AIS A injuries, there is no neurological function below the injury level. The second cohort will be patients classified as AIS B, in which there is some preservation of sensory or motor function below the injury level. The third cohort will be patients classified as AIS C, in which there is some preservation of both sensory and motor function.
All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and each of the patients will be invited to enroll into a separate four year observational study after completing the Phase I/II study.
The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. Enrollment for the second cohort is now underway. If you believe you may qualify and are interested in participating in the study, please contact the study nurse either by phone at +41 44 386 39 01 or by email at stemcells.pz@balgrist.ch.
Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm, including video interviews with Company executives and independent collaborators.
About Balgrist University Hospital
Balgrist University Hospital, University of Zurich is recognized worldwide as a highly specialized center of excellence providing examination, treatment and rehabilitation opportunities to patients with serious musculoskeletal conditions. The clinic owes its leading international reputation to its unique combination of specialized medical services. The hospital's carefully-balanced, interdisciplinary network brings together under one roof medical specialties including orthopedics, paraplegiology, radiology, anesthesiology, rheumatology, and physical medicine. More information about Balgrist University Hospital is available at http://www.balgrist.ch.
Mayo Clinic finds way to weed out problem stem cells, making therapy safer
By LizaAVILA
Public release date: 27-Sep-2012 [ | E-mail | Share ]
Contact: Jennifer Schutz newsbureau@mayo.edu 507-284-5005 Mayo Clinic
ROCHESTER, Minn. -- Mayo Clinic researchers have found a way to detect and eliminate potentially troublemaking stem cells to make stem cell therapy safer. Induced Pluripotent Stem cells, also known as iPS cells, are bioengineered from adult tissues to have properties of embryonic stem cells, which have the unlimited capacity to differentiate and grow into any desired types of cells, such as skin, brain, lung and heart cells. However, during the differentiation process, some residual pluripotent or embryonic-like cells may remain and cause them to grow into tumors.
"Pluripotent stem cells show great promise in the field of regenerative medicine; however, the risk of uncontrolled cell growth will continue to prevent their use as a therapeutic treatment," says Timothy Nelson, Ph.D., M.D., lead author on the study, which appears in the October issue of STEM CELLS Translational Medicine.
Using mouse models, Mayo scientists overcame this drawback by pretreated stem cells with a chemotherapeutic agent that selectively damages the DNA of the stem cells, efficiently killing the tumor-forming cells. The contaminated cells died off, and the chemotherapy didn't affect the healthy cells, Dr. Nelson says.
"The goal of creating new therapies is twofold: to improve disease outcome with stem cell-based regenerative medicine while also ensuring safety. This research outlines a strategy to make stem cell therapies safer for our patients while preserving their therapeutic efficacy, thereby removing a barrier to translation of these treatments to the clinic," says co-author Alyson Smith, Ph.D.
Stem cell therapies continue to be refined and improved. Researchers are finding that stem cells may be more versatile than originally thought, which means they may be able to treat a wider variety of diseases, injuries and congenital anomalies. Stem cell therapy is an emerging regenerative strategy being studied at Mayo Clinic.
"By harnessing the potential of regenerative medicine, we'll be able to provide more definitive solutions to patients," says Andre Terzic, M.D., Ph.D., co-author and director of Mayo Clinic's Center for Regenerative Medicine.
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Other members of the Mayo research team included Clifford Folmes, Ph.D., Katherine Hartjes, Natalie Nelson and Saji Oommen, Ph.D. The research was supported by the Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome, National Institutes of Health New Innovator Award OD007015-01, and a Mayo Clinic Center for Regenerative Medicine accelerated research grant.
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Mayo Clinic finds way to weed out problem stem cells, making therapy safer
UCLA stem cell researchers use gene therapy to restore immune systems in 'bubble babies'
By LizaAVILA
Public release date: 11-Sep-2012 [ | E-mail | Share ]
Contact: Kim Irwin kirwin@mednet.ucla.edu 310-435-9457 University of California - Los Angeles Health Sciences
UCLA stem cell researchers have found that a gene therapy regimen can safely restore immune systems to children with so-called "Bubble Boy" disease, a life threatening condition that if left untreated can be fatal within one to two years.
In the 11-year study, researchers were able to test two therapy regimens for 10 children with ADA-deficient severe combined immunodeficiency (SCID). During the study, they refined their approach to include a light dose of chemotherapy to help remove many of the blood stem cells in the bone marrow that are not creating an enzyme called adenosine deaminase (ADA), which is critical for the production and survival of healthy white blood cells, said study senior Dr. Donald Kohn, a professor of pediatrics and of microbiology, immunology, and molecular genetics in Life Sciences and a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA.
The refined gene therapy and chemotherapy regimen proved superior to the other method tested in the study, restoring immune function to three of the six children who received it, Kohn said. Going forward, an even further refined regimen using a different type of virus delivery system will be studied in the next phase of the study, which already has enrolled eight of the 10 patients needed.
The study appears Aug. 30 in the advance online issue of the peer-reviewed journal Blood.
"We were very happy that in the human trials we were able to see a benefit in the patients after we modified the protocol," Kohn said. "Doctors treating ADA-deficient SCID have had too few options for too long, and we hope this will provide them with an efficient and effective treatment for this devastating disease."
Children born with SCID, an inherited immunodeficiency, are generally diagnosed at about six months. They are extremely vulnerable to infectious diseases and don't grow well. Chronic diarrhea, ear infections, recurrent pneumonia and profuse oral candidiasis commonly occur in these children. SCID cases occur in about 1 of 100,000 births
Currently, the only treatment for ADA-deficient SCID calls for injecting the patients twice a week with the necessary enzyme, Kohn said, a life-long process that is very expensive and often doesn't return the immune system to optimal levels. These patients also can undergo bone marrow transplants from matched siblings, but matches can be very rare.
About 15 percent of all SCID patients are ADA-deficient. Kohn and his team used a virus delivery system that he had developed in his lab in the 1990s to restore the gene that produces the missing enzyme necessary for a healthy immune system. To date, about 40 children with SCID have received gene therapy in clinical trials around the world, Kohn said.
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UCLA stem cell researchers use gene therapy to restore immune systems in 'bubble babies'
Gloria Arroyo to have stem cell treatment Monday
By LizaAVILA
Former President and now Pampanga Rep. Gloria Macapagal-Arroyo will undergo stem cell therapy on Monday with an alternative medicine doctor.
Arroyo, in a post on her Twitter account Saturday morning, said Monday's session will be her fourth intravenous treatment.
"This Monday I will have my fourth stem cell intravenous treatment with my alternative medicine doctor," she said.
Also she said, "It's cultured stem cell and much more modest in price than the one coming from sheep or one's own body."
But she did not elaborate on how much the treatment will cost.
Stem cell therapy is type of intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury.
Earlier this week, Arroyo said she continues to search for alternative solutions to an anatomic problem that prompted her to be rushed to a government hospital last month.
Arroyo said she had seen at least two "alternative medicine practitioners," and has initiated communication with a "neurocervical spine purist."
She said she also had her thrice-weekly therapy at the Veterans Memorial Medical Center (VMMC) in Quezon City Thursday.
Arroyo underwent treatment last August for an anatomic problem that caused her to choke on her food.
Annabelle to undergo stem cell therapy
By LizaAVILA
MANILA, Philippines Talent manager Annabelle Rama revealed that she will be undergoing stem cell therapy in September.
She confirmed this report to The Philippine Stars entertainment columnist Ricky Lo.
Rama said shes been suffering from several illnesses and that stem cell therapy may help make her feel better.
Im suffering from high-blood pressure, high-blood sugar and other ailments and from what I heard, after the therapy I would feel better. Lahat daw yon gagaling, she said.
Rama said her son Richard Gutierrez, who will be paying for the whole procedure, also urged her to have her back problem checked.
Richard wants me to have my scoliosis checked and my lumbar region which are giving me so much pain. So I will have two more injections for that, each costing an extra one thousand euros, she said.
Lo said in his article that the whole package, which will include nine injections, will cost around P1 million.
Meanwhile, although she earlier vented on Twitter her disappointment that her family is against her plan to run for Congress, it seems that her children have changed their mind about politics.
Rama said she is hoping that she will feel renewed after her upcoming stem cell therapy so she will be ready to file her certificate of candidacy as a Cebu congresswoman when she comes back.
Richard and my other children want me to be physically fit for the campaign, Rama said.
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Annabelle to undergo stem cell therapy
NeoStem's Subsidiary, Progenitor Cell Therapy, and SOTIO Enter Into a Phase 3 Manufacturing Services Agreement
By LizaAVILA
ALLENDALE, N.J. and WILMINGTON, Del., July 16, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized Contract Development and Manufacturing Organization (CDMO), and SOTIO, LLC, a Delaware limited liability company that is responsible for organizing the U.S. part of a global pivotal Phase 3 clinical trial of SOTIO, LLC's affiliate, SOTIO a.s. ("SOTIO"), announced today that SOTIO, LLC has retained the services of PCT to manufacture clinical products for SOTIO's U.S. part of a global pivotal Phase 3 clinical trial. SOTIO, LLC is an affiliate of a Czech Republic-based biotechnology company developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. SOTIO, LLC will use the services of PCT to transfer and qualify at PCT's Allendale, New Jersey facility, SOTIO's GMP manufacturing process for the U.S. part of a global pivotal Phase 3 clinical trial for SOTIO's autologous dendritic cell vaccine expected to launch in early 2013, subject to FDA approval.
As part of this agreement, PCT will complete a technology transfer of SOTIO's current product manufacturing and analytical procedures into PCT's ongoing CDMO operations. PCT will then implement and perform process qualification at the Allendale facility, and manufacture, store, and release the product for SOTIO's U.S. part of its global pivotal Phase 3 trial. The U.S. part of this double-blinded, randomized trial will enroll up to 250 patients and will be SOTIO's first trial in the U.S.
"We are very excited to enter into this agreement to continue and to expand on our relationship with SOTIO, LLC, an innovator for cellular immunotherapies to treat prostate cancer," said Robert A. Preti, PhD, President and Chief Scientific Officer of PCT. "Given our best in class capabilities in the manufacture and distribution of cell-based immunotherapies, we are pleased to work with SOTIO, LLC to assist with bringing this exciting therapy and its potential to the U.S. PCT will offer SOTIO, LLC the same expertise and dedicated service it has offered past clients like the Dendreon Corporation (DNDN), for whom we were the primary manufacturer for PROVENGE(R) for more than seven years during its clinical trials."
"This agreement with PCT represents a major risk mitigation step in conducting the U.S. part of our global pivotal Phase 3 clinical trial," said Karel Nohejl, Chairman and CEO of SOTIO. "PCT has significant experience in manufacturing patient-specific products and capabilities to provide the scale-up needed for late-stage clinical trials. PCT's competencies in process and product implementation, quality assurance, and GMP manufacturing make it ideally suited as a manufacturing partner for SOTIO, LLC as we look forward to launching this trial in anticipation of entering the U.S. market."
"PCT offers cell therapy companies around the world a cost-effective method to transfer product candidate development to the U.S. and launch their products commercially," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "PCT's track record, experience with technology transfer, and U.S. footprint including its East and West Coast (Mountain View, California) facilities, make it an excellent partner for companies like SOTIO, LLC. Manufacturing contracts for cell therapy products can generate millions of dollars of revenue for the manufacturing partner over the span of a late stage clinical trial. We foresee meaningful client base growth as therapeutic development companies from Europe and Asia seek access to the American market and look for a U.S. contract development and manufacturing partner."
About SOTIO Group
SOTIO Group is a biotechnology group developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. Its mission is to develop new medical therapies using SOTIO's proprietary cell-based technologies to treat highly unmet medical conditions using SOTIO's immunotherapy platform. World renowned scientists are working at SOTIO's research facilities in Prague using state-of-the art technologies to understand the role of dendritic cells in the therapeutic activation of the body's immune response. SOTIO plans to start a global pivotal Phase 3 clinical trial which will enroll U.S. as well as E.U. patients under the supervision of FDA and EMA. SOTIO, LLC is an affiliate of SOTIO and is responsible for organizing SOTIO Group's activities in the United States.
For more information on SOTIO, please visit http://www.sotio.com
About NeoStem, Inc.
NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and Amorcyte is enrolling patients for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2012/2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.
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NeoStem's Subsidiary, Progenitor Cell Therapy, and SOTIO Enter Into a Phase 3 Manufacturing Services Agreement
Should people be allowed to sell their organs?
By LizaAVILA
Some worry that a ruling giving donors the ability to sell their bone-marrow tissue will encourage legal sale of other body parts.
STORY HIGHLIGHTS
(Time.com) -- How much would it take for you to consider selling your bone marrow? A U.S. appeals court puts the price at about $3,000 in a ruling that now makes it legal to pay donors for their bone-marrow tissue.
The court's decision may well help thousands of sick patients who need bone-marrow transplants to survive, but it also begs the question, What other body parts might next be up for sale?
The ruling came about at the end of 2011, in a decision to an October 2009 lawsuit brought by a group of cancer patients, parents and bone-marrow-donation advocates against the government over the federal law banning the buying and selling of bodily organs. The plaintiffs were led by Doreen Flynn, who has three daughters who suffer from Fanconi anemia, a blood disorder that requires bone-marrow transplants to treat.
Flynn and the other plaintiffs said that too many such patients die waiting for transplants and argued that we should be allowed to pay people to donate their marrow as a way of ensuring a more reliable supply. The U.S. Court of Appeals for the Ninth Circuit agreed.
Time.com: Facebook now lets organ donors tell their friends
At the core of the plaintiffs' argument was the National Organ Transplantation Act (NOTA), which since 1984 has forbid the buying and selling of human organs, including bone marrow. But new developments in bone-marrow extraction have made marrow donation not much different from donating blood.
Traditionally, bone-marrow donation required anesthesia and long needles to extract the marrow from the hip bones of donors. Now, a technique called peripheral apheresis allows doctors to extract blood stem cells directly from the blood, instead of the bone -- patients first take a drug that pulls stem cells from the bone and into the blood -- meaning that the marrow cells should be considered a fluid like blood, rather than an organ, the plaintiffs argued. NOTA doesn't prohibit payments for blood or other fluids, such as plasma or semen.
U.S. Attorney General Eric Holder decided not to ask the Supreme Court to review the appellate court's decision, which would have been the next step in overturning it. That means the ruling stands -- and that people can now be paid up to $3,000 for their marrow, as long as it is collected by apheresis. In a concession to the spirit of NOTA, however, the compensation can't be in cash; it needs to be in the form of a voucher that can be applied to things such as scholarships, education, housing or a donation to a charity.
Paying for Bone Marrow: Should We Be Able to Sell Our Parts?
By LizaAVILA
Ed Reschke / Getty Images
A color-enhanced photograph of spongy (Cancellous) bone red bone marrow fills the space.
How much would it take for you to consider selling your bone marrow? A U.S. appeals court puts the price at about $3,000 in a ruling that now makes it legal to pay donors for their bone-marrow tissue.
The courts decision may well help thousands of sick patients who need bone-marrow transplants to survive, but it also begs the question, what other body parts might next be up for sale?
The ruling came about at the end of 2011, in a decision to an October 2009 lawsuit brought by a group of cancer patients, parents and bone-marrow donation advocates against the government over the federal law banning the buying and selling of bodily organs. The plaintiffs were led by Doreen Flynn, who has three daughters who suffer from Fanconi anemia, a blood disorder that requires bone-marrow transplants to treat. Flynn and the other plaintiffs said that too many such patients die waiting for transplants and argued that we should be allowed to pay people to donate their marrow as a way of ensuring a more reliable supply. The U.S. Court of Appeals for the Ninth Circuit agreed.
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At the core of the plaintiffs argument was the National Organ Transplantation Act (NOTA), which since 1984 has forbid the buying and selling of human organs, including bone marrow. But new developments in bone-marrow extraction have made marrow donation not much different from donating blood: traditionally, bone marrow donation required anesthesia and long needles to extract the marrow from the hipbones of donors. Now, a technique called peripheral apheresis allows doctors to extract blood stem cells directly from the blood, instead of the bone patients first take a drug that pulls stem cells from the bone and into the blood meaning that the marrow cells should be considered a fluid like blood, rather than an organ, the plaintiffs argued. NOTA doesnt prohibit payments for blood or other fluids, such as plasma or semen.
U.S. Attorney General Eric Holder decided not to ask the Supreme Court to review the appellate courts decision, which would have been the next step in overturning it. That means the ruling stands and that people can now be paid up to $3,000 for their marrow, as long as it is collected by apheresis. In a concession to the spirit of NOTA, however, the compensation cant be in cash; it needs to be in the form of a voucher that can be applied to things such as scholarships, education, housing or a donation to a charity.
While the decision applies only to the nine states covered by the Ninth Circuit court, and only to bone marrow obtained through apheresis, it does raise bigger questions about how we will look at organ donation in the future. With about 114,000 people waiting for organs in the U.S. alone on any given day, and only 3,300 donors, the urgent medical need runs up against moral standards of the value human life. Once we start paying for the parts we need, though, how far do we go? We dont allow people to buy and sell human beings, thats slavery, says Dr. Robert Klitzman, director of the bioethics program at Columbia University. Should we allow people to buy and sell human body parts?
(MORE: Where Do (Some) Babies Come From? In Washington, a New Law Bans Anonymous Sperm and Egg Donors)
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Paying for Bone Marrow: Should We Be Able to Sell Our Parts?
In real time, Yale scientists watch stem cells at work regenerating tissue
By LizaAVILA
Scientists have for the first time watched and manipulated stem cells as they regenerate tissue in an uninjured mammal, Yale researchers report July 1 online in the journal Nature.
Using a sophisticated imaging technique, the researchers also demonstrated that mice lacking a certain type of cell do not regrow hair. The same technique could shed light on how stem cells interact with other cells and trigger repairs in a variety of other organs, including lung and heart tissue.
This tells us a lot about how the tissue regeneration process works, said Valentina Greco, assistant professor of genetics and of dermatology at the Yale Stem Cell Center, researcher for the Yale Cancer Center and senior author of the study.
Greco and her team focused on stem cell behavior in the hair follicle of the mouse. The accessibility of the hair follicle allowed real-time and non-invasive imaging through a technology called 2-photon intravital microscopy.
Using this method, Panteleimon Rompolas, a post-doctoral fellow in Grecos lab and lead author of this paper, was able to study the interaction between stem cells and their progeny, which produce all the different types of cells in the tissue. The interaction of these cells with the immediate environment determines how cells divide, where they migrate and which specialized cells they become.
The technology allowed the team to discover that hair growth in mice cannot take place in the absence of connective tissue called mesenchyme, which appears early in embryonic development.
Stem cells not only spur growth of hair in mammals including humans, but also can serve to regenerate many other types of tissues.
Understanding how stem cell behavior is regulated by the microenvironment can advance our use of stem cells for therapeutic purposes and uncover mechanisms that go wrong in cancer and other diseases, Greco said.
The study was funded by an Alexander Brown Coxe postdoctoral fellowship. This work was supported in part by the American Skin Association and the American Cancer Society and the Yale Rheumatologic Disease Research Core Center and the National Institutes of Health.
Other Yale authors include Elizabeth Deschene, Giovanni Zito, David G. Gonzalez, Ichiko Saotome and Ann M. Haberman.
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In real time, Yale scientists watch stem cells at work regenerating tissue
Former Auburn coach getting stem cell treatments for Lou Gehrig's disease
By LizaAVILA
MOBILE, Alabama -- The Baldwin County doctor that treated former Alabama football players with adult stem cells also has treated at least two people diagnosed with amyotrophic lateral sclerosis, also known as Lou Gehrigs disease.
One of the ALS patients, former NFL football player and college coach Frank Orgel, recently underwent a new stem cell reprogramming technique performed by Dr. Jason R. Williams at Precision StemCell in Gulf Shores.
Before the injections, Orgels health had declined. He could not move his left arm or leg. He couldnt walk or stand on his own, he said.
Within a few days of having the stem cell treatment, Orgels constant muscle twitching diminished, said Bob Hubbard, director of stem cell therapy at the practice. Within weeks, he was able to walk in a pool of water and stand unassisted.
I think its helped me, said Orgel, who was a defensive coordinator at Auburn under former head coach Pat Dye. Im walking in the pool and I used to drag my feet. Now my left leg is picking up.
ALS is a progressive neuro-degenerative disease that affects nerve cells in the brain and the spinal cord. The progressive degeneration of the motor neurons in ALS eventually leads to death, according to the ALS Association.
Stem cells, sometimes called the bodys master cells, are precursor cells that develop into blood, bones and organs, according to the U.S. Food and Drug Administration, which regulates their use. Their promise in medicine, according to many scientists and doctors, is that the cells have the potential to help and regenerate other cells.
While Williams treatments are considered investigational, he has said, they meet FDA guidelines because the stem cells are collected from a patients fat tissue and administered back to that patient during the same procedure.
Orgel, 74, said Williams told him it would take between eight months to a year for his nerves to regrow. He is traveling to Gulf Shores from his home in Albany, Ga., this weekend for another stem cell treatment, Orgel said: I need to get to where I can walk.
In recent years, Orgel has gone to Mexico at least three times for different types of treatments, not sanctioned in the U.S. At least once, he said, he had placenta cells injected into his body. That didnt work, Orgel said. I didnt feel any better.
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Former Auburn coach getting stem cell treatments for Lou Gehrig's disease
Ipo 8 weeks after stem cell therapy at Surf Paws Animal Hospital – Video
By LizaAVILA
28-06-2012 13:54 About 5 months ago, she came home from the beach with my husband limping on her right back leg. Now 8 weeks later after stem cell therapy... we were happy (well, maybe not so much...) to see her back to her old, wild, hyper self again.
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Ipo 8 weeks after stem cell therapy at Surf Paws Animal Hospital - Video
Taking the fate of stem cells in hand: RUB researchers generate immature nerve cells
By LizaAVILA
28.06.2012 - (idw) Ruhr-Universitt Bochum
RUB biologists have deliberately transformed stem cells from the spinal cord of mice into immature nerve cells. This was achieved by changing the cellular environment, known as the extracellular matrix, using the substance sodium chlorate. Via sugar side chains, the extracellular matrix determines which cell type a stem cell can generate. Influencing precursor cells pharmacologically so that they transform into a particular type of cell can help in cell replacement therapies in future says Prof. Dr. Stefan Wiese, head of the Molecular Cell Biology work group. Matrix modified Taking the fate of stem cells in hand RUB researchers generate immature nerve cells
RUB biologists have deliberately transformed stem cells from the spinal cord of mice into immature nerve cells. This was achieved by changing the cellular environment, known as the extracellular matrix, using the substance sodium chlorate. Via sugar side chains, the extracellular matrix determines which cell type a stem cell can generate. Influencing precursor cells pharmacologically so that they transform into a particular type of cell can help in cell replacement therapies in future says Prof. Dr. Stefan Wiese, head of the Molecular Cell Biology work group. Therapies, for example, for Parkinsons, multiple sclerosis or amyotrophic lateral sclerosis could then become more efficient. The team describes its findings in Neural Development.
Sulphate determines the fate of stem cells
Sodium chlorate acts on metabolism enzymes in the cell which attach sulphate groups to proteins. If these sulphates are not installed, the cell continues to form proteins for the extracellular matrix, but with modified sugar side chains. These chains in turn send out signals that define the fate of the stem cells. Stem cells can not only develop into nerve cells, but also form astrocytes or oligodendrocytes, which are, for instance, responsible for the mineral balance of the nerve cells or which form their insulation layer. What happens to the stem cells if the sulphate pattern is changed by sodium chlorate was examined by Dr. Michael Karus and his colleagues.
The RUB-laboratories of Prof. Dr. Stefan Wiese, Prof. Dr. Andreas Faissner and Prof. Dr. Irmgard Dietzel-Meyer collaborated for the study. Using antibodies, the researchers showed that cells which they had treated with sodium chlorate developed into nerve cells. They also analysed the flow of sodium ions into the cells. The result: treated cells showed a lower sodium current than mature nerve cells. Sodium chlorate thus favours the development of stem cells into nerve cells, but, at the same time, also inhibits the maturation - a positive side effect, as Wiese explains: If sodium chlorate stops the nerve cells in an early developmental phase, this could enable them to integrate into the nervous system following a transplant better than mature nerve cells would do.
Bibliographic record
M. Karus, S. Samtleben, C. Busse, T. Tsai, I.D. Dietzel, A. Faissner, S. Wiese (2012): Normal sulphation levels regulate spinal cord neural precursor cell proliferation and differentiation, Neural Development, doi:10.1186/1749-8104-7-20
Further information
Prof. Dr. Stefan Wiese, Molecular Cell Biology Work Group, Faculty of Biology and Biotechnology at the Ruhr-Universitt, 44780 Bochum, Germany, Tel. +49/234/32-22041 stefan.wiese@rub.de
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Taking the fate of stem cells in hand: RUB researchers generate immature nerve cells
Huntington's Research Tool Developed Using Stem Cells
By LizaAVILA
Main Category: Huntingtons Disease Also Included In: Stem Cell Research Article Date: 28 Jun 2012 - 9:00 PDT
Current ratings for: Huntington's Research Tool Developed Using Stem Cells
Cedars-Sinai scientists have joined with expert colleagues around the globe in using stem cells to develop a laboratory model for Huntington's disease, allowing researchers for the first time to test directly on human cells potential treatments for this fatal, inherited disorder.
As explained in a paper published June 28 on the Cell Stem Cell website and scheduled for print in the journal's Aug. 3 issue, scientists at Cedars-Sinai's Regenerative Medicine Institute and the University of Wisconsin took skin cells from patients with Huntington's disease and reprogrammed them into powerful stem cells; these were then made into the nervous system cells affected by the disease. Seven laboratories around the world collaborated to demonstrate the cells had hallmarks of Huntington's.
"This Huntington's 'disease in a dish' will enable us for the first time to test therapies on human Huntington's disease neurons," said Clive Svendsen, PhD, director of the Cedars-Sinai Regenerative Medicine Institute and a senior author of the study. "In addition to increasing our understanding of this disorder and offering a new pathway to identifying treatments, this study is remarkable because of the extensive interactions between a large group of scientists focused on developing this model. It's a new way of doing trailblazing science."
The Huntington's Disease iPSC Consortium united some of the world's top scientists working on this disease. Cedars-Sinai researchers took skin cells from a several Huntington's patients, including a six-year-old with a severe juvenile form of the disease. They genetically reprogrammed these tissues into induced pluripotent stem cells, which can be made into any type of cell in the body. The cells lines were banked by scientists at Cedars-Sinai and scrutinized by all consortium members for differences that may have led to the disease. These cell lines are now an important resource for Huntington's researchers and have been made available via a National Institutes of Health-funded repository at Coriell Institute for Medical Research in New Jersey.
Huntington's, known to the public, for example, as the cause of folksinger Woody Guthrie's death, typically strikes patients in midlife. It causes jerky, twitching motions, loss of muscle control, psychiatric disorders and dementia; the disease ultimately is fatal. In rare, severe cases, the disorder appears in childhood.
Researchers believe that Huntington's results from a mutation in the huntintin gene, leading to production of an abnormal protein and ultimately cell death in specific areas of the brain that control movement and cognition. There is no cure for Huntington's, nor therapies to slow its progression.
The consortium showed Huntington's cell deficits or how they differ from normal cells, including that they were less likely to survive cultivation in the petri dish. Scientists tried depriving them of a growth factor present around normal cells, or "stressing" them, and found that Huntington's neurons died even faster.
"It was great that these characteristics were seen not only in our laboratory, but by all of the consortium members using different techniques," said Virginia Mattis, a post-doctoral scientist at the Cedars-Sinai Regenerative Medicine Institute and one of the lead authors of the study. "It was very reassuring and significantly strengthens the value of this study."
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Huntington's Research Tool Developed Using Stem Cells
Turning skin cells into brain cells: Huntington's disease in a dish
By LizaAVILA
ScienceDaily (June 28, 2012) Johns Hopkins researchers, working with an international consortium, say they have generated stem cells from skin cells from a person with a severe, early-onset form of Huntington's disease (HD), and turned them into neurons that degenerate just like those affected by the fatal inherited disorder.
By creating "HD in a dish," the researchers say they have taken a major step forward in efforts to better understand what disables and kills the cells in people with HD, and to test the effects of potential drug therapies on cells that are otherwise locked deep in the brain.
Although the autosomal dominant gene mutation responsible for HD was identified in 1993, there is no cure. No treatments are available even to slow its progression.
The research, published in the journal Cell Stem Cell, is the work of a Huntington's Disease iPSC Consortium, including scientists from the Johns Hopkins University School of Medicine in Baltimore, Cedars-Sinai Medical Center in Los Angeles and the University of California, Irvine, as well as six other groups. The consortium studied several other HD cell lines and control cell lines in order to make sure results were consistent and reproducible in different labs.
The general midlife onset and progressive brain damage of HD are especially cruel, slowly causing jerky, twitch-like movements, lack of muscle control, psychiatric disorders and dementia, and -- eventually -- death. In some cases (as in the patient who donated the material for the cells made at Johns Hopkins), the disease can strike earlier, even in childhood.
"Having these cells will allow us to screen for therapeutics in a way we haven't been able to before in Huntington's disease," saysChristopher A. Ross, M.D., Ph.D., a professor of psychiatry and behavioral sciences, neurology, pharmacology and neuroscience at the Johns Hopkins University School of Medicine and one of the study's lead researchers. "For the first time, we will be able to study how drugs work on human HD neurons and hopefully take those findings directly to the clinic."
Ross and his team, as well as other collaborators at Johns Hopkins and Emory University, are already testing small molecules for the ability to block HD iPSC degeneration.These small molecules have the potential to be developed into novel drugs for HD.
The ability to generate from stem cells the same neurons found in Huntington's disease may also have implications for similar research in other neurodegenerative diseases such as Alzheimer's and Parkinson's.
To conduct their experiment, Ross took a skin biopsy from a patient with very early onset HD.When seen by Ross at the HD Center at Hopkins, the patient was just seven years old. She had a very severe form of the disease, which rarely appears in childhood, and of the mutation that causes it. Using cells from a patient with a more rapidly progressing form of the disease gave Ross' team the best tools with which to replicate HD in a way that is applicable to patients with all forms of HD.
Her skin cells were grown in culture and then reprogrammed by the lab of Hongjun Song, Ph.D., a professor at Johns Hopkins' Institute for Cell Engineering, into induced pluripotent stem cells. A second cell line was generated in an identical fashion in Dr. Ross's lab from someone without HD. Simultaneously, other HD and control iPS cell lines were generated as part of the NINDS funded HD iPS cell consortium.
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Turning skin cells into brain cells: Huntington's disease in a dish
Disease fight: turning skin cells to neurons
By LizaAVILA
Disease fight: turning skin cells to neurons June 28th, 2012, 4:04 pm posted by Pat Brennan, science, environment editor
UC Irvine professor Leslie Thompson, with human brain image behind her. Photo by Daniel A. Anderson, UC Irvine.
Using stem cells derived from skin cells, scientists including a UC Irvine team say they have created human neurons that exhibit the effects of Huntingtons disease promising the possibility of testing treatments for the deadly disorder in a petri dish.
Their discovery not only sidesteps ethical issues surrounding the use of human embryonic stem cells, but offers the chance to produce far more diseased neurons, at various stages of disease progression, than ever have been available to researchers before.
This is a relatively new technique where you can reprogram an adult cell, in this case a skin cell, back to this early stem-cell stage, and then guide those into making neurons, said Leslie Thompson, a UC Irvine professor and a senior author of a study announcing the discovery that was published online Thursday.
Huntingtons disease is an inherited, neurodegenerative disorder that is always fatal. It typically strikes in middle age, gradually robbing its victims of the ability to walk and interfering with other basic brain functions.
Huntington's disease cells on their way to becoming neurons. Image courtesy Leslie Thompson, UC Irvine.
Its like Parkinsons in that its a movement disorder in this case, involuntary movements, and rigidity, Thompson said. You know what is going on, but parts of memory are being impaired; you have an impaired ability to walk, think, talk.
Victims typically die of the diseases effects falling, or choking during pneumonia and some especially severe mutations can strike young children. The disease affects about 30,000 people in the United States, and no treatments exist even to slow the onset of symptoms.
The scientists, including UCIs Leslie Lock and Peter Donovan, director of the Sue and Bill Gross Stem Cell Research Center, as well as others from universities around the country and in Italy and Great Britain, used a variety of cell lines to reveal the genetic underpinnings of Huntingtons.
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Disease fight: turning skin cells to neurons