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Audubon center in Algiers logs another breakthrough in genetic engineering of ... NOLA.com By Mark Waller, The Times-Picayune A year after introducing the first pair of rare African black-footed kittens conceived through in vitro fertilization, the scientists at the Audubon Center for Research of Endangered Species in Algiers have announced ... and more »

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TechCentral

Synthetic biology: genetic engineering on steroids TechCentral You can also leave a comment below this article Whether or not we agree with it, we're all pretty used to the idea of genetic engineering. Our food chain is full of GM crops and pretty soon we may be genetically modified ourselves. Synthetic Biology BrouhahaGenetic Engineering News (blog) all 3 news articles »

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Nature.com

Merck & Co. to Invest $90M to Set Up New Translational Med Center in San Diego Genetic Engineering News Merck & Co. will join with a chemist-turned-biotechnology entrepreneur to launch the California Institute for Biomedical Research (Calibr) in La Jolla, CA, with the goal of advancing discoveries into new drugs. Merck will provide the new nonprofit ... Merck Partners with Academic Scientists and Biotechnology Entrepreneurs to ...MarketWatch (press release) Deals and Moves: March 16NJBIZ Merck collaboration will create non-profit drug research instituteThe Star-Ledger - NJ.com all 64 news articles »

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Stem cell researchers and institutions throughout the state are likely to be affected by proposed changes – to be discussed online publicly Tuesday – dealing with how the California stem cell agency will handle its $3 billion in grants.

An important online session – open to all interested parties – comes up then, but advance registration is required.

The proposals are wide-ranging and detailed. The nearly 500 recipients of CIRM grants should examine them closely in addition to any persons seriously interested in California stem cell affairs. The changes deal with such subjects as milestones for research grants, indirect costs, travel costs, withholding payments for failure to file a progress report and much, much more.

Here is a link to the main page for all this, which has instructions on how to register for the online session along with links to the changes and their rationale.

(Editor's note: This item was filed from the Rio Sabana in the Darien in Panama when we found a weak Internet cellular link. We are still underway so postings are unlikely between now and later this month.)

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For about three days in January, Matt Ladd said he didnt know whether it was day or night, what was top or bottom.

I was probably as sick as Ive ever been, said Ladd, a Billings game warden, in a telephone interview from Seattle. As things got progressively worse and worse, I was really concerned about what was going on right then.

Ladd was headed to Seattle for stem cell bone marrow transplant surgery when an infection he was being treated for worsened. The infection started around a catheter inserted into his chest to deliver chemotherapy drugs. The chemo was battling Ladds acute myeloid leukemia and myelodysplastic syndrome, which was diagnosed in September. His bone marrow wasnt producing enough red blood cells.

The chemo worked. He was in remission and on his way to Seattle for a bone marrow transplant when the infection sent him into a rapid downward spiral. Because of the location of the catheter, the infection attacked his heart valves. During the struggle with the infection, his kidneys failed, his body retained water and he swelled up.

The infection scuttled plans for the bone marrow transplant surgery. With his kidneys failing, he had to undergo dialysis. As a final insult to his immune system, he had to take more chemotherapy since the surgery had been delayed and doctors feared the MDS might return.

My body and kidneys didnt respond well to the chemo, he said.

More than a month after he was scheduled to undergo surgery, Ladd is living in an apartment north of Seattle as family members rotate caretaking duties. His wife, Maureen, a math teacher at Billings West High, is holding down the fort at home, trying to maintain a sense of normalcy for their sons, Dylan, Logan and Jack.

What was going to be a short process has become a very long process, Maureen said.

Now the Ladds are waiting to hear whether Matt and his sister, Jessica Cook, will take part in a Seattle Cancer Center Alliance study of a new method of bone marrow transplantation. Since Ladds kidneys have been injured, he would normally have to have a reduced-intensity transplant used for the elderly and those with health issues, Maureen explained.

The experimental method would treat Cook, Ladds only sibling and a bone marrow transplant match, with Lipitor prior to the surgery. The cholesterol-lowering drug has shown promise in preventing reactions to transplants. If they are accepted for the study, it would mean a further delay of surgery, since Cook would have to be on the drug for a couple of weeks prior to the operation.

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Billings game warden fights cancer complications

A NEW stem cell therapy treatment to develop new bones for patients with bone loss and new skin for recipients of plastic surgery has been developed, doctors from Shanghai No.9 People's Hospital announced yesterday.

In the procedure, medical staff use a special machine to collect stem cells from a patient's blood. The stem cells adhere to a base made of a special biological material.

The stem cells are then transplanted into the patient's body, where they grow into either new bones or skin tissue, while the base is absorbed by the human body.

"So far the practice has been successful in treating patients with bone and skin loss," said Dr Dai Kerong from Shanghai Jiao Tong University's translational medicine institute at Shanghai No.9 hospital. "The stem cell technology will be used to develop corneas for blind people as well as treating heart attack and stroke patients by developing new heart and cerebral tissue."

The technology is patented in China and abroad and will be licensed within one or two years, according to Dai.

China has established 51 translational medicine centers to boost the introduction of laboratory research into clinical use.

The complicated procedures and documentation required often prevent doctors from introducing lab success into clinical practice.

Dai said one reagent developed by No. 9 hospital's doctors for in vitro fertilization received a license in Europe within six months and has been used in clinical practice "while this would take at least five years in China."

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Eastday-Big stem cell breakthrough

OTTAWA A team of Canadian researchers has been awarded $442,000 to test the world's first experimental stem-cell therapy aimed at patients who suffer from septic shock, a runaway infection of the bloodstream that's notoriously difficult to treat.

The federal grant will allow researchers from the Ottawa Hospital Research Institute to use mesenchymal stem cells, found in the bone marrow of healthy adults, to treat as many as 15 patients with septic shock.

The deadly infection occurs when toxic bacteria spreads rapidly throughout the body and over-activates the immune system, leading to multiple organ failure and death in up to 40 per cent of cases.

One in five patients admitted to intensive-care units suffers from septic shock, making it the most common illness among a hospital's sickest of the sick.

Existing treatments focus on early diagnosis and intervention before organs start to fail. Patients with septic shock require aggressive resuscitation measures, large doses of intravenous antibiotics and, often, ventilators to help them breathe.

Yet because the infection can creep up on patients rapidly and cause unpredictable complications, death from septic shock remains relatively common.

The experimental therapy aims to use donor stem cells, grown and purified at the Ottawa laboratory, to dial down the body's hyperactive immune response and reduce the cascade of inflammation that leads to organ failure.

Early results from animal studies even raise the possibility that mesenchymal cells could eliminate the bacteria that causes septic shock, although the impact on humans is not yet known.

"It's a unique feature of the stem cells," said Dr. Lauralyn McIntyre, the intensive-care physician who is leading the trial. "Certainly no other therapy in the past, other than antibiotics, has impacted the bacterial load in the system."

As with other stem cells, mesenchymal cells can turn into a variety of more specialized cells and tissues that help repair and regenerate damaged organs. And because mesenchymal cells are derived from adults, they sidestep the ethical issues arising from the destruction of human embryos needed to make embryonic stem cells.

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Canadian researchers receive grant to test stem-cell therapy for septic shock

Public release date: 15-Mar-2012 [ | E-mail | Share ]

Contact: Diane Schrick diane.schrick@gladstone.ucsf.edu 415-734-2538 Gladstone Institutes

SAN FRANCISCO, CAMarch 15, 2012Gladstone Institutes Senior Investigator Deepak Srivastava, MD has won the prestigious 2012 Abraham White Scientific Achievement Award from The George Washington University. Dr. Srivastava, who directs cardiac and stem cell research at Gladstone will share the award with Dr. Luigina Romani, professor of microbiology at the University of Perugia.

Dr. Srivastava is being recognized for his findings concerning how the protein thymosin beta 4 is vital to protect and repair cells that become damaged in a heart attackpointing the way to its potential use in treating cardiac disease. His research has shown that thymosin beta 4 is not only critical to the development of a heart, but that it also prevents heart cells from dyingwhile stimulating new blood vessels to form.

"Dr. Srivastava's pioneering studies and scientific contributions have significantly advanced our understanding of the role of thymosin beta 4 in the development and function of the human heart," said Allan Goldstein, PhD, professor and emeritus chairman of The George Washington University. "His studies have provided the scientific foundation for the potential use of thymosin beta 4 to treat heart attacks and other heart diseases."

Dr. Srivastava, who joined Gladstone in 2005, uses modern genetic and stem cell technologies to identify the molecular events that instruct progenitor cells to become cardiac cellsand subsequently fashion a functioning heart. In addition to his research with thymosin beta 4, Dr. Srivastava and his lab have successfully reprogrammed connective tissue in the heart directly into beating heart cellsa process that may help regenerate damaged heart muscle.

"Heart disease is the leading cause of death in the United States and basic research in this field is vital to identifying and understanding the causes of human heart disease," said Dr. Srivastava, who is also a professor of pediatrics, biochemistry and biophysics at the University of California, San Francisco (UCSF), with which Gladstone is affiliated. "I am honored to receive this award and hope our efforts ultimately lead to important new treatments for patients with heart conditions."

George Washington University presents the Abraham White Scientific Achievement Award annually to honor individuals who have made unique contributions to science and medicine. Notable past recipients include Nobel laureates Bengt Samuelsson, MD, Julius Axelrod, MD, Michael Brown, MD, Joseph Goldstein, MD and Tim Hunt, PhD in addition to a number of other distinguished scientists. The award will be presented today at a special ceremony in Washington D.C.

"We are delighted that George Washington University has acknowledged Dr. Srivastava's exceptional achievements in the field of cardiovascular research," said Gladstone President R. Sanders Williams, MD. "He richly deserves this recognition due to the creativity and innovation evident in his workand because of its potential to benefit the millions of individuals suffering from cardiac disorders."

Before joining Gladstone, Dr. Srivastava was a professor in the department of pediatrics and molecular biology at the University of Texas Southwestern (UTSW) Medical Center in Dallas. He has received numerous honors and awards, including endowed chairs at UTSW and UCSF, as well as election to the American Society for Clinical Investigation, the Society for Pediatric Research, the American Academy of Arts and Sciences and the American Association for the Advancement of Science.

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Gladstone director receives 2012 Abraham White Scientific Achievement Award

The same species that submitted itself to experimentation for treatments to human cancers is now getting a cure with N.C. State's first canine bone marrow transplant.

In 2008, Dr. Steven Suter, assistant professor of oncology, began performing bone marrow transplants, BMT, on dogs. N.C. State is the only university in the world that offers this treatment. While private practices do exist, mainly on the west coast, they have treated few dogs. People have traveled from across the country to utilize these services.

Once I became an oncologist, I realized that this could probably be done now in a clinical setting if the appropriate machines could be found, apheresis machines. Once I got a hold of some of these machines, I started collecting peripheral blood progenitor cells from a few research colony dogs. After I showed we could do that, we moved on to start transplanting client-owned dogs. We opened our canine BMT unit in October 2008, Suter said.

Until recently, the transplants used stem cells from the dogs' own blood, so only those who had a disease in remission could be treated. The treatment was typically used on dogs with lymphoma.

The cure rate of dogs with lymphoma treated with chemotherapy is less than 5 percent, so I felt we could do better on that front with BMT, Suter said. We have modified the protocol extensively since the first 24 dogs, so we are hoping it will now be better.

However this all changed with two Cavalier King Charles Spaniels, Chip and Zeke, earlier this year. Zeke was diagnosed with acute lymphocytic leukemia in December 2011. This disease could only be treated by use of donor bone marrow. Chip, a littermate, was the prime choice.

We do require a donor, since we can not harvest progenitor cells from the patient. Leukemia patients have too many cancer cells floating around in their blood, so the machine would harvest them also. So, we find a matched donor who does not have cancer obviously, and harvest the cells from them, Suter said. We don't use this procedure regularly to treat dogs with leukemia ... we've treated two dogs with leukemia. We use it mainly to treat dogs with lymphoma, which is a very different disease."

The owners of the dogs met for the first time at N.C. State for the procedure to take place.

Jason Hefner, a fourth year in veterinary medicine, worked with Zeke while he was here.

To our knowledge, only one previous case has been treated with a donor. Zeke had a great disposition, and I looked forward to visiting him each morning for his treatments. Zeke is now in New York and looking forward to a happy and healthy life, Hefner said.

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University gives dog a bone marrow transplant

ScienceDaily (Mar. 14, 2012) A research team has identified epigenetic signatures, markers on DNA that control transient changes in gene expression, within reprogrammed skin cells. These signatures can predict the expression of a wound-healing protein in reprogrammed skin cells or induced pluripotent stem cells (iPSCs), cells that take on embryonic stem cell properties. Understanding how the expression of the protein is controlled brings us one step closer to developing personalized tissue regeneration strategies using stem cells from a patient, instead of using human embryonic stem cells.

The study was published in the Journal of Cell Science.

When skin cells are reprogrammed, many of their cellular properties are recalibrated as they aquire stem cell properties and then are induced to become skin cells again. In order for these "induced" stem cells to be viable in treatment for humans (tissue regeneration, personalized wound healing therapies, etc.), researchers need to understand how they retain or even improve their characteristics after they are reprogrammed.

Since the initial discovery of reprogramming, scientists have struggled with the unpredictability of the cells due to the many changes that occur during the reprogramming process. Classifying specific epigenetic signatures, as this study did, allows researchers to anticipate ways to produce cell types with optimal properties for tissue repair while minimizing unintended cellular abnormalities.

The researchers used reprogrammed cells to generate three-dimensional connective tissue that mimics an in vivo wound repair environment. To verify the role of the protein (PDGFRbeta) in tissue regeneration and maintenance, the team blocked its cellular expression, which impaired the cells' ability to build tissue.

"We determined that successful tissue generation is associated with the expression of PDGFRbeta. Theoretically, by identifying the epigenetic signatures that indicate its expression, we can determine the reprogrammed cells' potential for maintaining normal cellular characteristics throughout development," said first author Kyle Hewitt, PhD, a graduate of the cell, molecular & developmental biology program at the Sackler School of Graduate Biomedical Sciences, and postdoctoral associate in the Garlick laboratory at Tufts University School of Dental Medicine (TUSDM).

"The ability to generate patient-specific cells from the reprogrammed skin cells may allow for improved, individualized, cell-based therapies for wound healing. Potentially, these reprogrammed cells could be used as a tool for drug development, modeling of disease, and transplantation medicine without the ethical issues associated with embryonic stem cells," said senior author Jonathan Garlick, DDS, PhD, a professor in the department of oral and maxillofacial pathology and director of the division of tissue engineering and cancer biology at TUSDM.

Jonathan Garlick is also a member of the cell, molecular & developmental biology program faculty at the Sackler School and the director of the Center for Integrated Tissue Engineering (CITE) at TUSDM.

Additional authors of the study are Yulia Shamis, MSc, a PhD candidate in the cell, molecular, and developmental biology program at the Sackler School; Elana Knight, BSc, and Avi Smith, BA, both research technicians in the Garlick laboratory; Anna Maione, a PhD student in the cell, molecular & developmental biology program at the Sackler School, and Addy Alt-Holland, PhD, MSc, assistant professor at TUSDM.

This work was supported by grant # DE017413 to Dr. Garlick from the National Institute for Dental and Craniofacial Research, part of the National Institutes of Health.

Excerpt from:
Epigenetic signatures direct the repair potential of reprogrammed cells

OTTAWA A team of Ottawa researchers has been awarded $442,000 to test the worlds first experimental stem-cell therapy aimed at patients who suffer from septic shock, a runaway infection of the bloodstream thats notoriously difficult to treat.

The federal grant will allow researchers from the Ottawa Hospital Research Institute to use mesenchymal stem cells, found in the bone marrow of healthy adults, to treat as many as 15 patients with septic shock.

The deadly infection occurs when toxic bacteria spreads rapidly throughout the body and over-activates the immune system, leading to multiple organ failure and death in up to 40 per cent of cases.

One in five patients admitted to intensive-care units suffers from septic shock, making it the most common illness among a hospitals sickest of the sick.

Existing treatments focus on early diagnosis and intervention before organs start to fail. Patients with septic shock require aggressive resuscitation measures, large doses of intravenous antibiotics and, often, ventilators to help them breathe.

Yet because the infection can creep up on patients rapidly and cause unpredictable complications, death from septic shock remains relatively common.

The experimental therapy aims to use donor stem cells, grown and purified at the Ottawa laboratory, to dial down the bodys hyperactive immune response and reduce the cascade of inflammation that leads to organ failure.

Early results from animal studies even raise the possibility that mesenchymal cells could eliminate the bacteria that causes septic shock, although the impact on humans is not yet known.

Its a unique feature of the stem cells, said Dr. Lauralyn McIntyre, the intensive-care physician who is leading the trial. Certainly no other therapy in the past, other than antibiotics, has impacted the bacterial load in the system.

Like other stem cells, mesenchymal cells can turn into a variety of more specialized cells and tissues that help repair and regenerate damaged organs. And because mesenchymal cells are derived from adults, they sidestep the ethical issues arising from the destruction of human embryos needed to make embryonic stem cells.

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Ottawa researchers receive grant to test stem-cell therapy for septic shock

SUNRISE, Fla., March 15, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has successfully conducted a laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine. The attendees participated in hands on, in depth training in laboratory practices in stem cell science.

"We had students from all over the world attend this first course including physicians, laboratory technicians and students," said Mike Tomas, Bioheart's President and CEO. "Bioheart is pleased to be able to share our 13 years of experience in stem cell research and help expand this growing life science field."

The course included cell culture techniques and quality control testing such as flow cytometry and gram stain. In addition, participants learned how to work in a cleanroom operating according to FDA cGMP standards, regulations used in the manufacture of pharmaceuticals, food and medical devices. Aseptic techniques were also taught as well as cleanroom gowning, environmental monitoring and maintenance.

Future courses are open to physicians, laboratory technicians and students. After graduating the course, attendees are prepared to pursue research and careers in the field of stem cells and regenerative medicine. For more information about the course, contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

EDMONDS, Wash., March 14, 2012 /PRNewswire/ --Washington Center for Pain Management is participating in a nationwide FDA-cleared adult stem cell study testing novel treatment for chronic low back pain and has enrolled its first patient. The study will test the use of Mesenchymal Precursor Cells (MPCs) adult stem cells derived from bone marrow that will be directly injected into the lumbar disc. The minimally invasive procedure may offer an alternative to back surgery for eligible patients with chronic pain from degenerative discs.

An estimated 30 million people in the United States suffer from back pain. Degenerative disc disease is the most common cause of low-back pain, which develops with the gradual loss of a material called proteoglycan, which cushions the bones of the spine and enables normal motion.

Most patients with low-back pain respond to physical therapy and medications, but in advanced cases, artificial disc replacement or spinal fusion -- removal of the degenerated discs and the fusion of the bones of the spine -- is necessary. However, these surgeries often are not entirely effective.

"Millions of Americans are debilitated by chronic low back pain," says Dr Hyun Joong Hong MD, the lead investigator at The Washington Center for Pain Management. "This promising therapy is at the cutting edge of medical science and has the potential to create a paradigm shift in our approach to minimally invasive solutions to this disease."

Researchers will enroll approximately 100 study participants. About fifteen participants will be enrolled at The Washington Center for Pain Management and the rest at 11 other medical centers throughout the United States. The trial is scheduled to last for three years.

Washington Center for Pain Management is enrolling study participants suffering from moderate low-back pain for a minimum of six months and whose condition has not responded to other, conventional treatments.

Once enrolled, patients are randomly assigned to one of four treatment groups:

Patients will receive a single injection of their assigned test agent directly into the center of the target discs within their spine and will be monitored for safety. Patients will also be monitored using imaging to identify any changes in their disease condition or disease progression. Use of pain medications, self-reports of pain, subsequent surgical interventions and assessments of disability, quality of life, productivity and activity will be evaluated. Repair of the disc and reduction of chronic back pain will be assessed in each patient.

Promising results have been observed in prior research using animal models when stem cells were investigated for the repair of damaged spine discs. The cells were well tolerated in these study animals.

This study is sponsored by Mesoblast Limited, a world leader in the development of biologic products for the broad field of regenerative medicine. Mesoblast has the worldwide exclusive rights to a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs). The MPCs are derived from young adult donors' bone marrow and are immune tolerant.

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Washington Center for Pain Management Begins Enrollment in United States Stem Cell Therapy Study in Subjects With ...

LEUVEN, BELGIUM--(Marketwire -03/15/12)- TiGenix NV (EURONEXT: TIG) today gave a business update and announced financial results for the full year 2011.

Business highlights

Financial highlights

"TiGenix has created a new and strong basis in 2011 on which we can build going forward and we have strengthened our position as the European leader in cell therapy," says Eduardo Bravo, CEO of TiGenix. "We have delivered on our promises: we have obtained national reimbursement for ChondroCelect in Belgium and made progress in other European markets. We advanced all clinical stem cell programs on plan, and raised substantial funds from specialized healthcare investors and through non-dilutive financing. Today, TiGenix is well-positioned to reach the next value-enhancing inflection points."

Business Update

Successful integration of Cellerix reinforces leadership position in cell therapyIn May 2011, TiGenix closed the business combination with the stem cell therapy company Cellerix, creating the European leader in cell therapy. During 2011 the Company succeeded in rapidly integrating both entities. The Company now combines top line revenues with an advanced pipeline of clinical stage regenerative and immuno-modulatory products. TiGenix's operations are supported by a strong commercial and manufacturing infrastructure for advanced cell therapies, an experienced international management team and a solid cash position.

As a result of the merger, the Company's development focus has shifted from early stage preclinical programs towards a number of highly promising clinical stage products for inflammatory and autoimmune disorders of high unmet medical need, each addressing markets in excess of EUR 1 billion. TiGenix product pipeline is based on a proprietary stem cell platform that exploits expanded allogeneic (donor-derived) adult stem cells derived from human adipose (fat) tissue ('eASCs'). The platform has been extensively characterized in line with requirements of the European Medicines Agency (EMA) and is supported by exhaustive preclinical and CMC packages.

Given its focus on cell therapy, TiGenix is in the process of divesting its ChondroMimetic franchise, which is based on a biomaterial platform. To be able to concentrate on its core business and move forward with a clean slate, TiGenix has decided to write-off the intellectual property related to the OrthoMimetics acquisition.

ChondroCelect commercial roll-out progressing with first national reimbursementChondroCelect obtained reimbursement in Belgium in May 2011, and is today available in 22 specialized treatment centers.

TiGenix is selling ChondroCelect in the UK, the Netherlands, Germany, and Spain under managed access and private insurance schemes, while pursuing national reimbursement in these countries and France.

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TiGenix Reports Full Year 2011 Financial Results

Public release date: 15-Mar-2012 [ | E-mail | Share ]

Contact: Jennifer Ganton jganton@ohri.ca 613-798-5555 x73325 Ottawa Hospital Research Institute

A team of researchers from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa (uOttawa) has been awarded $367,000 from the Canadian Institutes of Health Research (CIHR) and $75,000 from the Stem Cell Network to lead the first clinical trial in the world of a stem cell therapy for septic shock. This deadly condition occurs when an infection spreads throughout the body and over-activates the immune system, resulting in severe organ damage and death in 30 to 40 per cent of cases. Septic shock accounts for 20 per cent of all Intensive Care Unit (ICU) admissions in Canada and costs $4 billion annually. Under the leadership of Dr. Lauralyn McIntyre, this new "Phase I" trial will test the experimental therapy in up to 15 patients with septic shock at The Ottawa Hospital's ICU.

The treatment involves mesenchymal stem cells, also called mesenchymal stromal cells or MSCs. Like other stem cells, they can give rise to a variety of more specialized cells and tissues and can help repair and regenerate damaged organs. They also have a unique ability to modify the body's immune response and enhance the clearance of infectious organisms. They can be found in adult bone marrow and other tissues, as well as umbilical cord blood, and they seem to be easily transplantable between people, because they are more able to avoid immune rejection.

There has been a great deal of interest in using MSCs to treat disease, with most research so far focused on heart disease, stroke, inflammatory bowel disease and blood cancers. Hundreds of patients with these diseases have already been treated with MSCs through clinical trials, with results suggesting that these cells are safe in these patients, and have promising signs of effectiveness. MSCs are still considered experimental however, and have not been approved by Health Canada as a standard therapy for any disease.

In recent years, a number of animal studies have suggested that MSCs may also be able to help treat septic shock. For example, a recent study by Dr. Duncan Stewart, CEO and Scientific Director of OHRI (and also a co-investigator on the new clinical trial) showed that treatment with these cells can triple survival in a mouse model of this condition.

"Mesenchymal stem cell therapy appears promising in animal studies, but it will require many years of clinical trials involving hundreds of patients to know if it is safe and effective," said Dr. Lauralyn McIntyre, a Scientist at the OHRI, ICU Physician at The Ottawa Hospital, Assistant Professor of Medicine at uOttawa and a New Investigator with CIHR and Canadian Blood Services. "This trial is a first step, but it is a very exciting first step."

As with all "Phase I" trials, the main goal of this study is to evaluate the safety of the therapy and determine the best dose for future studies. The 15 patients in the treatment group will receive standard treatments (such as fluids, antibiotics and blood pressure control), plus a planned intravenous dose of 0.3 to 3 million MSCs per kg of body weight. The MSCs will be obtained from the bone marrow of healthy donors and purified in the OHRI's Good Manufacturing Practice Laboratory in the Sprott Centre for Stem Cell Research. The researchers also plan to evaluate 24 similar septic shock patients who will receive standard treatments only (no MSCs). All patients will be rigorously monitored for side effects, and blood samples will be taken at specific time points to monitor the cells and their activity. This trial will not be randomized or blinded and it will not include enough patients to reliably determine if the therapy is effective. It will be conducted under the supervision of Health Canada and the Ottawa Hospital Research Ethics Board, and will have to be approved by both of these organizations before commencing.

"The OHRI is rapidly becoming known as a leader in conducting world-first clinical trials with innovative therapies such as stem cells," said Dr. Duncan Stewart, CEO and Scientific Director of OHRI, Vice-President of Research at The Ottawa Hospital and Professor of Medicine at uOttawa. "This research is truly pushing the boundaries of medical science forward, and is providing the citizens of Ottawa with access to promising new therapies."

"The Canadian Institutes of Health Research (CIHR) is very pleased to support this clinical trial," said Dr. Jean Rouleau, Scientific Director of the CIHR Institute of Circulatory and Respiratory Health. "The work of Dr. McIntyre and her colleagues will not only add to our growing knowledge of the benefits of stem-cell therapies, but will hopefully lead to treatments that can help save the lives of patients where currently, our treatment options are less than optimal."

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Ottawa researchers to lead world-first clinical trial of stem cell therapy for septic shock

Edited by M. A. Hayat 384 pp, $209 New York, NY, Springer, 2012 ISBN-13: 978-9-4007-2015-2

Stem cells and cancer stem cells are 2 distinct, evolving, and promising areas of research. Hematopoietic stem cells are already used in the treatment of bone marrow failure and hematologic malignancies, and there is now great interest in isolating stem cells from other organs for use in replenishing damaged tissue in the heart, brain, bones, and other organs and structures. In contrast, cancer stem cells, a newly recognized component of some cancers, have some properties of pluripotent stem cells in that they replicate without normal cell cycle regulation and apoptosis. Moreover, they are naturally resistant to chemotherapy because of drug-exuding pumps, DNA repair proteins, and dormancy; thus, these cells are now suspected to be the root cause of relapse and metastasis after conventional therapies in some malignancies, especially leukemia. Targeting cancer stem cells in addition to cancer cells may therefore lead to better eradication of cancer than is presently possible.

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Stem Cells and Cancer Stem Cells: Therapeutic Applications in Disease and Injury, Volume 2 [Book and Media Reviews]

14 March 2012 Last updated at 09:00 ET By Jane O'Brien BBC News, Maine

Please turn on JavaScript. Media requires JavaScript to play.

One of Doreen Flynn's daughters, 13-year-old Jordan, says the whole transplant process scares her

A mother in the US is desperate to find bone marrow donors to save the lives of her three daughters who are critically ill from a rare blood disorder. Now, she is challenging a federal law barring her from compensating prospective donors.

Thousands of Americans who need transplants die every year because they cannot find a suitable donor, advocates say.

They propose a controversial way to encourage more people to come forward: Pay them.

"It is widening the donor pool. A lot of times employers don't pay for the time off that these donors take from work," says Doreen Flynn of Lewiston, Maine.

"So I think in those instances those people can say, 'you know I can do that,' knowing that there will be a support system for them at the end."

Ms Flynn's three daughters have a rare genetic blood disorder called Fanconi Anaemia. Their bone marrow does not make enough blood cells to keep them healthy and their only hope for survival is a transplant.

It is against US law to sell body parts - including bone marrow. But last year, Ms Flynn won a court ruling in favour of compensating donors whose blood stem cells are collected using a process called aphaeresis.

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Should it be legal to pay for bone marrow donations?

ScienceDaily (Mar. 13, 2012) For the first time, scientists at the University of Wisconsin-Madison have made early retina structures containing proliferating neuroretinal progenitor cells using induced pluripotent stem (iPS) cells derived from human blood.

And in another advance, the retina structures showed the capacity to form layers of cells as the retina does in normal human development and these cells possessed the machinery that could allow them to communicate information. (Light-sensitive photoreceptor cells in the retina along the back wall of the eye produce impulses that are ultimately transmitted through the optic nerve and then to the brain, allowing you to see.) Put together, these findings suggest that it is possible to assemble human retinal cells into more complex retinal tissues, all starting from a routine patient blood sample.

Many applications of laboratory-built human retinal tissues can be envisioned, including using them to test drugs and study degenerative diseases of the retina such as retinitis pigmentosa, a prominent cause of blindness in children and young adults. One day, it may also be possible replace multiple layers of the retina in order to help patients with more widespread retinal damage.

We dont know how far this technology will take us, but the fact that we are able to grow a rudimentary retina structure from a patients blood cells is encouraging, not only because it confirms our earlier work using human skin cells, but also because blood as a starting source is convenient to obtain, says Dr. David Gamm, pediatric ophthalmologist and senior author of the study. This is a solid step forward.

In 2011, the Gamm lab at the UW Waisman Center created structures from the most primitive stage of retinal development using embryonic stem cells and stem cells derived from human skin. While those structures generated the major types of retinal cells, including photoreceptors, they lacked the organization found in more mature retina.

This time, the team, led by Gamm, Assistant Professor of Ophthalmology and Visual Sciences in the UW School of Medicine and Public Health, and postdoctoral researcher and lead author Dr. Joseph Phillips, used their method to grow retina-like tissue from iPS cells derived from human blood gathered via standard blood draw techniques.

In their study, about 16 percent of the initial retinal structures developed distinct layers. The outermost layer primarily contained photoreceptors, whereas the middle and inner layers harbored intermediary retinal neurons and ganglion cells, respectively. This particular arrangement of cells is reminiscent of what is found in the back of the eye. Further, work by Dr. Phillips showed that these retinal cells were capable of making synapses, a prerequisite for them to communicate with one another.

The iPS cells used in the study were generated through collaboration with Cellular Dynamics International (CDI) of Madison, Wis., who pioneered the technique to convert blood cells into iPS cells. CDI scientists extracted a type of blood cell called a T-lymphocyte from the donor sample, and reprogrammed the cells into iPS cells. CDI was founded by UW stem cell pioneer Dr. James Thomson.

We were fortunate that CDI shared an interest in our work. Combining our labs expertise with that of CDI was critical to the success of this study, added Dr. Gamm.

Other members of the research team include:

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Scientists produce eye structures from human blood-derived stem cells

Editor's Choice Academic Journal Main Category: Diabetes Article Date: 13 Mar 2012 - 12:00 PDT

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The study was carried out by Chutima Talchai, Ph.D, a New York Stem Cell Foundation-Druckenmiller Fellow, and Domenico Accili, M.D., professor of medicine at Columbia University Medical Center.

Type 1 diabetes is an autoimmune disease that kills cells in the pancreas which produce insulin, resulting in high levels of glucose in the blood. As the pancreas is unable to replace these cells, individuals suffering with the disease must inject insulin into themselves in order to manage their blood sugar. Patients must also monitor their sugar levels numerous times a day, as blood glucose that is too low or too high can be fatal.

For scientists researching type 1 diabetes, one of the leading goals is to replace lost insulin-producing cells with new cells that release insulin into the bloodstream as needed. Even though researchers are able to generate these cells in the laboratory from embryonic stem cells, they are not suitable for transplant in patients as they do not release insulin appropriately in response to sugar levels, potentially resulting in a deadly condition called hypoglycemia.

In the intestine of mice, the researchers found that certain gastrointestinal progenitor cells are able to generate insulin-producing cells.

Usually, progenitor cells are responsible for generating a vast range of cells, such as gastric inhibitory peptide, cells that produce serotonin, as well as other hormones secreted into the GI tract and bloodstream.

The researchers discovered that when they switched off Foxo1 (a gene known to contribute in cell fate decisions), the progenitor cells also generated cells that produced insulin. In addition, the team found that although more cells were produced when Foxo1 was switched off early in development, they were also produced when the Foxo1 was switched off in adult mice.

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Gut Cells Turned To Insulin Factories - New Type l Diabetes Treatment