Multiple myeloma patients are better equipped to halt progression of this blood cancer if treated with lenalidomide, or Revlimid-, following a stem cell transplant, according to a study co-authored by a physician with the Oregon Health & Science University Knight Cancer Institute.

The study, published in the New England Journal of Medicine, found a 63 percent reduction in the risk of progressive myeloma or death for the stem cell transplant patients that were treated with lenalidomide maintenance therapy.

“These results add to the evidence that the combination of standard therapies such as stem cell transplantation with the emerging biologic therapies, like lenalidomide, have extended the lives of multiple myeloma patients,” said Richard Maziarz, M.D., of the OHSU Knight Cancer Institute who was one of the study’s co-authors. Maziarz serves as medical director of the Adult Stem Cell Transplantation Program & Center for Hematologic Malignancies at the OHSU Knight Cancer Institute. “We know that for at least three years following a transplant that maintenance therapy with this drug vastly improves the chances that the cancer won’t come back and worsen.”

These data were supported by similar Phase III studies reported from France and Italy in the same issue of the New England Jounal of Medicine demonstrating that maintenance therapy after stem cell transplantation was associated with improved disease control.

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Lenalidomide following stem cell transplant can halt progression of blood cancer

Veterinarians hope a new medical procedure can treat a 25-year-old chimpanzee with a torn ACL, or anterior cruciate ligament, at the “Save the Chimps” in Florida.

The procedure involves injecting the chimp with her own stem cells.

“With chimps we don’t want to do a lot of surgical work, put hardware in their knee, they tend to pull out that sort of thing,” said Veterinarian Linda Gregard, M.D.

Dr. Darrell Nazareth with the Florida Veterinary League has been using stem cells to treat dogs with arthritis for the past two years, but this is his first chimp.

“We’re not using embryonic stem cells, we’re not taking embryos and taking their stem cells from there. We’re just using the patient’s own tissue,” said Dr. Nazareth.

The technology harnesses the bodies own ability to heal itself and doctors hope it could find wider use in humans.

After injecting two billion stem cells into Angie’s knee, doctors will find out in the next two to three weeks if the stem cell therapy treatment was successful.

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Stem cell therapy to treat a chimp's torn ACL may prove beneficial for humans

Thirty Percent of Patients Show Improved Functioning after Stem Cell Therapy

Philadelphia, Pa. (May 17, 2012) One of the first long-term studies of stem cell treatment for spinal cord injury shows significant functional and other improvements in three out of ten patients, reports a study in the May issue of Neurosurgery, official journal of the Congress of Neurological Surgeons. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

The results support the safety of mesenchymal stem cells (MSCs) derived from the patient’s own bone marrow, showing “continuous and gradual motor improvement” in at least some patients with disability caused by spinal cord injury. The lead author of the new study was Dr. Sang Ryong Jeon of University of Ulsan College of Medicine, Seoul, South Korea.

Evidence of Improved Function after MSC Treatment for Spinal Cord Injury The researchers performed MSC transplantation in ten patients with permanent motor (movement) deficits or paralysis (paraplegia or quadriplegia) after spinal cord injury. Mesenchymal stem cells are a type of “multipotent” cell that can be cultured from adult bone marrow and induced to develop into many different types of cells.

The cultured MSCs were injected directly into the injured spinal cord and the surrounding (intradural) space. Additional cells were injected after another four and eight weeks. The results were assessed by measuring improvement in the patients’ ability to move their arms and hands and to perform key activities of daily living. Imaging scans and tests of muscle activity were performed as well.

During the first six months after MSC transplantation, six of the ten patients showed improvement in motor power of the arms and hands. Of these, three patients had gradual improvement in the ability to perform daily activitiesfor example, preparing meals and typing on a keyboard.

These three patients also showed significant changes on MRI scans of the spinal cord, including evidence of healing around the injured area of the spine. They also had improvement in electrophysiologic studies of muscle electrical activity.

No Long-Term Safety Problems of MSC Transplant None of the ten patients had any permanent complications related to MSC transplantation. This helps to alleviate concerns that MSC injection could lead to later problems like the development of tumors or calcifications.

Previous studies have shown promising results with MSC transplantation in animals and humans with spinal cord injury. Mesenchymal cells have some important potential advantages for stem cell therapy, as they are a relatively easily accessible source of the patient’s own cells. The ten patients treated by Dr. Jeon and colleagues represent the first attempt at direct spinal injection of MSCs for the treatment of spinal cord injury in humans.

Following up on a previous study reporting initial improvement in six patients, the new paper describes continued improvementincluding meaningful gains in the ability to perform everyday functional tasksin three patients. Dr. Jeon and colleagues note that all three patients with progressive improvement had some “residual neurological function.” They write, “Therefore, MSC treatment is more likely to enhance the remaining neurological function rather than rengeneration.” They call for further studies to understand the mechanism of improvement after MSC treatment and to clarify which patients with spinal cord injury are most likely to benefit.

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Stem Cells for Spinal Cord Injury: Some Patients Have Long-Term Improvement

IRVINE, Calif.–(BUSINESS WIRE)–

California Stem Cell, Inc. (CSC) announced today that well-known stem cell & regenerative medicine industry veteran Gregory A. Bonfiglio, J.D. has joined its Board of Directors.

Gregory Bonfiglio has over 25 years of experience working with technology companies, and was an early investor in the stem cell industry. He is Managing Partner of Proteus Venture Partners, an investment & advisory firm he founded in early 2006 to provide venture funding and strategic advisory services in the stem cell & regenerative medicine space. Mr. Bonfiglio is on the Boards of VistaGen Therapeutics and StemCyte, Inc.; he is the Chairman of the Board of the Centre for Commercialization of Regenerative Medicine (RM Translation Center in Toronto, Canada). In addition, Mr. Bonfiglio sits on the Advisory Board and Finance Committee of the International Society for Stem Cell Research (ISSCR); he is on the Commercialization Committee of the International Society for Cellular Therapy (ISCT).

Mr. Bonfiglio brings to CSC an extensive background in strategic consulting, having held partnership positions with various legal and venture firms, and having successfully led a team that took pioneering stem cell company Advanced Cell Technology public in early 2005. Were thrilled to welcome to our board someone with the breadth of industry experience that Greg has, and are very much looking forward to his participation in the continued growth of this Company, said COO Chris Airriess.

This appointment coincides with a ramp up of commercial product sales as well as advancements of CSCs active Phase II clinical trial in metastatic melanoma.

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA based company which has developed proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.

CSC is focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.

Follow us on Twitter: http://twitter.com/castemcell

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Industry Consultant Gregory Bonfiglio Joins California Stem Cell Board of Directors

BOSTON (Reuters) – Osiris Therapeutics Inc said on Thursday that Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world. Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells …

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Canada OKs Osiris drug; first stem cell therapy

By Meg Tirrell – 2012-05-17T20:35:40Z

Osiris Therapeutics Inc. (OSIR) said it won the worlds first approval for a stem-cell drug, gaining clearance in Canada to sell Prochymal for a disease that can attack patients who received bone-marrow transplants.

Prochymal was approved for the treatment of acute graft versus host disease in children for whom steroids havent worked, the Columbia, Maryland-based company said today in a statement. Steroids have a 30 percent to 50 percent success rate, and severe GvHD can be fatal in 80 percent of cases, according to the company.

The therapy uses mesenchymal stem cells derived from bone marrow that can take on different forms, to combat the immune reaction that causes patients to literally peel out of their skin and shed their intestinal lining, Osiris Chief Executive Officer Randal Mills said in a telephone interview. The disease has no equal.

The company hasnt sought approval for this indication in the U.S., where regulators asked for more data before considering whether to allow sales of the drug, Mills said. Prochymal already is used in eight countries, including the U.S., on an expanded-access program basis, which allows patients to receive experimental medicines without participating in clinical trials.

This is the first regulatory approval of a stem-cell drug — where the active ingredient of the drug is a stem cell — in the world, Mills said. Its a huge deal for us and a huge deal for the entire field of stem-cell therapy.

Osiris fell less than 1 percent to $5.26 at the close of trading in New York. The shares have declined from an all-time high of $28.56 in 2007 as Osiris faced clinical setbacks, including two studies in 2009 that failed to show statistical improvement of Prochymal versus placebo.

The Canadian approval was based on data showing a clinically meaningful response 28 days after starting therapy for 61 percent to 64 percent of patients treated, Osiris said in the statement.

Prochymal may draw $16.7 million in revenue next year with Canadian approval, estimated Edward Tenthoff, an analyst with Piper Jaffray & Co. He said that while Prochymal, if successful in Canada, would be the first stem-cell drug to receive approval, other regenerative products used for wound-healing that employ stem cells are already on the market, such as Carticel from Sanofis Genzyme unit. That treatment uses a patients own cells to repair cartilage injuries in the knee, and is implanted with surgery, whereas Prochymal is an intravenous, off-the-shelf therapy. The stem cells are derived from bone marrow donations from healthy donors.

Progress in stem-cell research has been halting. Geron Corp. (GERN), based in Menlo Park, California, started the first U.S.- approved trial of human embryonic stem cells before ending the program last year because of research costs and regulatory complexities.

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Osiris Wins Canadian Approval for First Stem-Cell Therapy

COLUMBIA, Md.–(BUSINESS WIRE)–

Osiris Therapeutics Inc. (NASDAQ:OSIR – News) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The historic decision marks the worlds first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

“I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope,” said Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal. “As a result of Health Canada’s comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920′s, with stem cells we have now officially taken the first step into this new paradigm of medicine.”

Prochymal was authorized under Health Canada’s Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.

Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last.

Health Canadas authorization was made following the recommendation of an independent expert advisory panel, commissioned to evaluate Prochymal’s safety and efficacy. In Canada, Prochymal is now authorized for the management of acute GvHD in children who fail to respond to steroids. The approval was based on the results from clinical studies evaluating Prochymal in patients with severe refractory acute GvHD. Prochymal demonstrated a clinically meaningful response at 28 days post initiation of therapy in 61-64 percent of patients treated. Furthermore, treatment with Prochymal resulted in a statistically significant improvement in survival when compared to a historical control population of pediatric patients with refractory GvHD (p=0.028). The survival benefit was most pronounced in patients with the most severe forms of GvHD. As a condition of approval, the clinical benefit of Prochymal will be further evaluated in a case matched confirmatory trial and all patients receiving Prochymal will be encouraged to participate in a registry that will monitor the long-term effects of the therapy.

Refractory GvHD is not just deadly to the patients it afflicts, but is devastating for the family, friends, and caregivers who watch helplessly as the disease progresses, said Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal. “I have personally seen Prochymal reverse the debilitating effects of severe GvHD in many of my patients and now, after nearly two decades of research, the data demonstrating consistently high response rates, a strong safety profile and improved survival clearly support the use of Prochymal in the management of refractory GvHD.”

Prochymal is currently available in several countries, including the United States, under an Expanded Access Program (EAP). Prochymal will be commercially available in Canada later this year.

Today Osiris turns the promise of stem cell research into reality, delivering on decades of medical and scientific research, said Peter Friedli, Chairman and Co-founder of Osiris. It took 20 years of hard work and perseverance and I want to personally thank everyone involved for their dedication to this important mission.

In addition to the extensive intellectual property protection Osiris has around Prochymal, which includes 48 issued patents, Health Canada’s decision will also provide Prochymal with regulatory exclusivity within the territory. Canada affords eight years of exclusivity to Innovative Drugs such as Prochymal, and an additional six-month extension is available since it addresses a pediatric population.

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World's First Approved Stem Cell Drug; Osiris Receives Marketing Clearance from Health Canada for Prochymal

May 16, 2012

Dentists have long warned that too much sugar can rot a persons teeth, but scientists at UCLA have discovered evidence that too much soda and candy could also rot a persons brain.

The study, which was published Tuesday in the Journal of Physiology, discovered how a diet that is steadily high in fructose can slow down the function of the brain, impairing memory and learning ability, the Los Angeles-based university said in a May 15 press release. Those adverse effects, they say, can emerge in as little as six weeks time, but can be counteracted to some degree by adding omega-3 fatty acids to ones diet.

Our findings illustrate that what you eat affects how you think, Fernando Gomez-Pinilla, one of the authors of the study and a professor of neurosurgery at the David Geffen School of Medicine at UCLA said in a statement. Eating a high-fructose diet over the long term alters your brains ability to learn and remember information. But adding omega-3 fatty acids to your meals can help minimize the damage.

Were not talking about naturally occurring fructose in fruits, which also contain important antioxidants, Gomez-Pinilla, a professor of integrative biology and physiology in the UCLA College of Letters and Science as well as a member of UCLAs Brain Research Institute and Brain Injury Research Center, added. Were concerned about high-fructose corn syrup that is added to manufactured food products as a sweetener and preservative.

Gomez-Pinilla and co-author Rahul Agrawal, a visiting postdoctoral fellow, studied two groups of rats that were given a solution that contained high-fructose corn syrup as drinking water for a six-week period, according to AFP reports. One of the groups was also given flaxseed oil and docosahexaenoic acid (DHA), both omega-3 fatty acids, while the other was not.

Prior to the start of the experiment, both groups of rats completed a five-day training session on how to navigate a complex maze. Following six weeks of the corn syrup treatment, they were re-entered into the maze, and the researchers observed their performance. Gomez-Pinilla told AFP that the rodents that did not receive DHA and flaxseed oil were slower and demonstrated a decline in synaptic activity.

They also showed signs of insulin-resistance, according to the UCLA press release.

Because insulin can penetrate the bloodbrain barrier, the hormone may signal neurons to trigger reactions that disrupt learning and cause memory loss, Gomez-Pinilla said. Insulin is important in the body for controlling blood sugar, but it may play a different role in the brain, where insulin appears to disturb memory and learning. Our study shows that a high-fructose diet harms the brain as well as the body. This is something new.

Our findings suggest that consuming DHA regularly protects the brain against fructoses harmful effects, he added. Its like saving money in the bank. You want to build a reserve for your brain to tap when it requires extra fuel to fight off future diseases.

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Can Too Much Sugar Make You Stupid?

By Scicurious| May 16, 2012 |

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DOES environmental enrichment make your rat sexy? Today, Im over at Neurotic Physiology examining a paper on whether environmental enrichment drives the lady rats wild, and why that might be the case. Ive got a few issues with the paper. The data is fine but its all in the interpretation. Head over and check it out.

(But it does come with this awesome sexy rat drawing from MysticGaia, used with permission of the artist)

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The views expressed are those of the author and are not necessarily those of Scientific American.

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Environment Enrichment: making your rat sexy since 2012

Pathology businesses in three states, ACT sold. 16 May 2012 9:46 AM

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Sonic to buy Healthscope pathology assets