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Malaya Business Insight

June 27th, 2012 9:14 pm

Details Published on Thursday, 28 June 2012 00:00 Written by PHILIP S. CHUA

Excessive video gaming (desktop or hand-held) is hazardous to childrens body, brain, and health in general, causing anxiety, depression and poor performance in school.

ARE soft drinks really bad for our health?

Most definitely, yes. On average, there are 10 to 15 calories per ounce of non-diet soft drinks, so a 12-ounce can contains 120-180 calories. Drinking a can of this liquid candy a day adds an extra 120 calories to the days diet. Statistics show that an extra 100 calories a day leads to a weight gain of 10 pounds a year. Imagine what drinking a can with every meal could do to your health. But, worse than calories, is the more dangerous fact that imbibing soft drinks is associated with the development of Metabolic Syndrome (central obesity leading to high blood pressure, high cholesterol, insulin resistance, diabetes, heart attack, stroke).

All of us should abandon soft drinks and also save our children from this dangerous drink. Red wine, even for children (as practices in some European countries), would be safer than these treacherous and subtle poisons.

I hate daily insulin shots; any alternative?

If your diabetes is not controlled by pills and your physician prescribes diet, exercise and insulin for you, it will be wise for you to follow this custom-tailored regimen, otherwise complications of diabetes could ravage your entire body and shorten your life. Since you hate insulin shots like every diabetic, you could consider implantation of an Insulin Pump.

This is the state-of-the-art method of administering insulin to insulin dependent diabetic patients. The small device is implanted under the skin and the catheter connected to it is inserted into a vein. The computerized pump contains insulin in its chamber and delivers a precise dose of insulin at a preset time schedule. The insulin chamber is refillable. This pump replaces the needle injection as a method of giving insulin. Further down the line, embryonic stem cell transplant may someday become a routine cure for diabetes.

Do video games hurt children?

Excessive video gaming (desktop or hand-held) is hazardous to childrens body, brain, and health in general, causing anxiety, depression and poor performance in school, according to a study published by the American Academy of Pediatrics.

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Diabetes breakthrough as experts learn how to completely reverse the condition in mice

June 27th, 2012 9:14 pm

Study mice were able to produce their own insulin following human stem cell transplant

By Daily Mail Reporters

PUBLISHED: 11:33 EST, 27 June 2012 | UPDATED: 11:34 EST, 27 June 2012

Scientists have successfully reversed diabetes in mice using stem cells, paving the way for a breakthrough treatment for the illness.

The research is the first to show that human stem cell transplants can successfully restore insulin production and reverse diabetes in mice.

Crucially, the team re-created the 'feedback loop' that enables insulin levels to automatically rise or fall based on blood glucose levels.

Diabetics must take regular blood tests to check their blood glucose levels. Scientists have been able to restore normal insulin-producing cells in mice

Diabetes affects more than two million people in Britain.

After the stem cell transplant, the diabetic mice were weaned off insulin, a procedure designed to mimic human clinical conditions. Three to four months later, the mice were able to maintain healthy blood sugar levels even when being fed large quantities of sugar.

Transplanted cells removed from the mice after several months had all the markings of normal insulin-producing pancreatic cells.

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Stem cells can beat back diabetes: UBC research

June 27th, 2012 9:12 pm

Public release date: 27-Jun-2012 [ | E-mail | Share ]

Contact: Brian Kladko brian.kladko@ubc.ca 604-827-3301 University of British Columbia

University of British Columbia scientists, in collaboration with an industry partner, have successfully reversed diabetes in mice using stem cells, paving the way for a breakthrough treatment for a disease that affects nearly one in four Canadians.

The research by Timothy Kieffer, a professor in the Department of Cellular and Physiological Sciences, and scientists from the New Jersey-based BetaLogics, a division of Janssen Research & Development, LLC, is the first to show that human stem cell transplants can successfully restore insulin production and reverse diabetes in mice. Crucially, they re-created the "feedback loop" that enables insulin levels to automatically rise or fall based on blood glucose levels. The study is published online today in the journal Diabetes.

After the stem cell transplant, the diabetic mice were weaned off insulin, a procedure designed to mimic human clinical conditions. Three to four months later, the mice were able to maintain healthy blood sugar levels even when being fed large quantities of sugar. Transplanted cells removed from the mice after several months had all the markings of normal insulin-producing pancreatic cells.

"We are very excited by these findings, but additional research is needed before this approach can be tested clinically in humans," says Kieffer, a member of UBC's Life Sciences Institute. "The studies were performed in diabetic mice that lacked a properly functioning immune system that would otherwise have rejected the cells. We now need to identify a suitable way of protecting the cells from immune attack so that the transplant can ultimately be performed in the absence of any immunosuppression."

The research was supported by the Canadian Institutes of Health Research, the Stem Cell Network of Canada, Stem Cell Technologies of Vancouver, the JDRF and the Michael Smith Foundation for Health Research.

Diabetes results from insufficient production of insulin by the pancreas. Insulin enables glucose to be stored by the body's muscle, fat and liver and used as fuel; a shortage of insulin leads to high blood sugar that raises the risk of blindness, heart attack, stroke, nerve damage and kidney failure.

Regular injections of insulin are the most common treatment for the type 1 form of this disease, which often strikes young children. Although experimental transplants of healthy pancreatic cells from human donors have shown to be effective, that treatment is severely limited by the availability of donors.

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Differences between type 1 and 2 diabetes

June 27th, 2012 9:12 pm

True or false: Type 1 diabetes is only diagnosed in children, and type 2 diabetes only occurs later in life. Although type 1 diabetes used to be known as juvenile diabetes and type 2 was called adult-onset diabetes, the answer is actually false, said Lindsey Elder and Erin Boccia, certified diabetes educators at the Community Diabetes Outreach Services center in Newton, Kan. Not everyone who has type 1 diabetes was diagnosed with the disease as a child, and children can be diagnosed with type 2 diabetes. And while both diseases affect the bodys production of insulin, there are some major differences between the two conditions. Diabetes is a pretty complex disease, Boccia said.

About type 1 diabetes Elder and Boccia said type 1 diabetes is an autoimmune disease. The bodys immune system mistakes insulin-producing cells for foreign invaders, and then attacks and destroys those cells. Those with type 1 diabetes produce little to no natural insulin, and they will need to remain on insulin treatments for the rest of their lives. The onset of type 1 diabetes typically is rather rapid, with symptoms such as frequent urination and extreme thirst. The disease is not preventable and is not impacted by lifestyle choices. Research into pancreas transplants and stem cell treatments have shown some promise.

About type 2 diabetes Most cases of diabetes about 90 to 95 percent are type 2. Unlike type 1 diabetes, this disease develops through insulin resistance rather than insulin destruction. The body continues to produce insulin but doesnt use it efficiently. The insulin-producing cells can lose function gradually over time. Elder and Boccia said type 2 diabetes is impacted by a persons diet and lifestyle choices. Being overweight or obese, particularly in the stomach area, can increase your risk for developing type 2 diabetes, as can a family history of diabetes. Treatment options include managing diet and exercise, oral and injectable medications, and insulin.

Living with diabetes Elder and Boccia said the key to living a healthy, normal life with diabetes is learning as much as you can about your condition. Contact a local diabetes education center, such as the Community Diabetes Outreach Services center in Newton, and find out the best treatment plan for you. Its important to control your blood sugar levels, or complications such as eye and kidney problems can result. Its also important to take an active role in your treatment. Its every day, Boccia said. Its largely a self-managed disease. The doctor cant be with you 24/7 to make those decisions.

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Diabetes reversed in mice using stem cells

June 27th, 2012 9:12 pm

ScienceDaily (June 27, 2012) University of British Columbia scientists, in collaboration with an industry partner, have successfully reversed diabetes in mice using stem cells, paving the way for a breakthrough treatment for a disease that affects nearly one in four Canadians.

The research by Timothy Kieffer, a professor in the Department of Cellular and Physiological Sciences, and scientists from the New Jersey-based BetaLogics, a division of Janssen Research & Development, LLC, is the first to show that human stem cell transplants can successfully restore insulin production and reverse diabetes in mice. Crucially, they re-created the "feedback loop" that enables insulin levels to automatically rise or fall based on blood glucose levels. The study is published online June 27 in the journal Diabetes.

After the stem cell transplant, the diabetic mice were weaned off insulin, a procedure designed to mimic human clinical conditions. Three to four months later, the mice were able to maintain healthy blood sugar levels even when being fed large quantities of sugar. Transplanted cells removed from the mice after several months had all the markings of normal insulin-producing pancreatic cells.

"We are very excited by these findings, but additional research is needed before this approach can be tested clinically in humans," says Kieffer, a member of UBC's Life Sciences Institute. "The studies were performed in diabetic mice that lacked a properly functioning immune system that would otherwise have rejected the cells. We now need to identify a suitable way of protecting the cells from immune attack so that the transplant can ultimately be performed in the absence of any immunosuppression."

The research was supported by the Canadian Institutes of Health Research, the Stem Cell Network of Canada, Stem Cell Technologies of Vancouver, the JDRF and the Michael Smith Foundation for Health Research.

Diabetes results from insufficient production of insulin by the pancreas. Insulin enables glucose to be stored by the body's muscle, fat and liver and used as fuel; a shortage of insulin leads to high blood sugar that raises the risk of blindness, heart attack, stroke, nerve damage and kidney failure.

Regular injections of insulin are the most common treatment for the type 1 form of this disease, which often strikes young children. Although experimental transplants of healthy pancreatic cells from human donors have shown to be effective, that treatment is severely limited by the availability of donors.

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MYOS Names Veteran Biotechnology Executive Dr. Sol J. Barer to Chair Scientific Advisory Board

June 27th, 2012 9:12 pm

CEDAR KNOLLS, NJ--(Marketwire -06/27/12)- MYOS Corporation (MYOS), a company focused on the discovery, development and commercialization of muscle health and performance therapeutic products, today announced that it has appointed Sol J. Barer, Ph.D., to Chair its Scientific Advisory Board.

Dr. Barer is the former Chairman and Chief Executive Officer of Celgene Corporation, a leading global biotechnology company specializing in cancer, hematologic and immunologic pharmaceuticals. He retired last year from a successful Celgene career where he served as Chairman from 2006 to 2011, and Chief Executive Officer from 2006 to 2010. Prior, he served as Celgene President and Chief Operating Officer since 1993, and 1994, respectively.

Dr. Barer serves as a director of a number of corporate and not-for-profit Boards.

Commenting on his appointment to Chairman of the MYOS Scientific Advisory Board, Dr. Barer said, "The nascent field of muscle biology and the technologies which maximize the health and performance of this organ system represents significant, previously untapped potential. MYOS is positioning itself to play an important and meaningful role in the discovery, development and clinical use of new products which will improve the health and performance of an organ system which we often forget is so vital to the quality of our lives.

"I am especially pleased to serve in this position so early in the Company's development, and to collaborate with its Board and growing management team," he added.

Commenting on Dr. Barer's appointment, Chairman of the MYOS Board of Directors Robert J. Hariri, M.D., Ph.D., said, "It is a special honor to welcome my long time colleague, friend and mentor, Dr. Barer to the Advisory Board. I consider Sol to be one of the visionary leaders who have helped shape the biotechnology industry, and truly value his insight into our sector's science, marketplace and corporate development."

Dr. Hariri serves as chief executive officer of Celgene Cellular Therapeutics, a division of Celgene Corporation, a position he has held since 2005. Prior to joining Celgene Cellular Therapeutics as president in 2002, Dr. Hariri was founder, chairman and chief scientific officer at Anthrogenesis Corporation/LIFEBANK, Inc., a privately held biomedical technology and service corporation involved in human stem cell therapeutics, which was acquired by Celgene in 2002.

About MYOS CorporationMYOS Corporation is a development stage company focused on the discovery, development and commercialization of therapeutic products that improve muscle health and performance (www.myoscorp.com).

MYOS is the owner of MYO-T12, the world's first clinically demonstrated myostatin inhibitor. Myostatin is a natural regulatory protein, which inhibits muscle growth and recovery. MYO-T12 is manufactured to optimize biological activity, which MYOS believes has the potential to redefine existing standards of physical health and wellness enhancement. For more information on MYO-T12 and to discover why MYOS is known as "The Muscle Company," visit http://www.MYOT12.com.

Forward-Looking StatementsAny statements in this release that are not historical facts are forward-looking statements. Actual results may differ materially from those projected or implied in any forward-looking statements. Such statements involve risks and uncertainties, including but not limited to those relating to product and customer demand, market acceptance of our products, the ability to create new products through research and development, the successful launch of Myo-X, the ability to generate the forecasted revenue stream and cash flow from sales of Myo-X, the ability to achieve a sustainable profitable business, the effect of economic conditions, the ability to protect our intellectual property rights, competition from other providers and products, risks in product development, our ability to raise capital to fund continuing operations, and other factors discussed from time to time in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to update or revise any forward-looking statement for events or circumstances after the date on which such statement is made except as required by law.

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Global Collaboration Enables Stem Cell Therapy to Rehabilitate Tragically Burned 3-Year-Old

June 27th, 2012 9:11 pm

Johannesburg, South Africa (PRWEB) June 27, 2012

After three-year-old Isabella Pippie Kruger was burned on over 80% of her body in a tragic accident, her mother was left searching for a viable option to repair her extremely damaged skin and save her life.

The solution came from across the globe in the form of a company called Genzyme in Boston, MA. Genzyme has developed a protocol for cultivating autologous epidural stem cells in order to generate new skin for patients who have suffered extreme skin trauma.

Genzyme was able to graft 41 sheets of new skin that was made of Pippies own genetic material. This was then flown across the world to South Africa, where the procedure of grafting her new skin took place. It was the first time this type of procedure was administered in South Africa.

Global collaboration in the administration of stem cell therapies to treat previously untreatable conditions is accelerating the paradigm shift in the medical community for the treatment of disease, trauma and injury; a shift that is spearheaded by the utilization of autologous stem cells. The use of the patients own stem cells in emerging regenerative therapies eliminates the chance of rejection of the transplanted tissue and the need for immuno-suppression drugs leading to more favorable outcomes.

To learn more about how families can bank their own, valuable stem cells to ensure access to a variety of emerging regenerative treatments and therapies, visit http://www.stemsave.com or call 877-783-6728 (877-StemSave) today.

The future of Regenerative Medicine is now.

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FDA critical of stem-cell firm

June 27th, 2012 3:22 am

The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration.

In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for therapeutic reinjection.

You have not performed a validation of your banking and thawing process to assure viability of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive.

The FDA report, which followed an April inspection of Celltex, was released under the Freedom of Information Act on Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained that Celltex is a potential danger to patients and not in compliance with federal law.

The report, partially redacted, was not accompanied by a warning letter.

A former FDA official who asked not to be identified, said the deficiencies 79 in all, from incorrectly labeled products to failed sterility tests are so serious that Celltex risks being shut down if it does not remedy the problems quickly.

Adult stem cells are cells in the body that multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have shown promise for tissue repair in many other diseases in the last decade, although most scientists in the field consider them not ready for mainstream use.

Celltex has been in the public eye since it was revealed that Perry's Houston doctor treated him with his own stem cells during back surgery last July and in follow-up appointments. His stem cells were stored and grown at Celltex.

Perry subsequently called for Texas to become the nation's leader of adult stem-cell medicine, which he touts as an ethical alternative to embryonic stem cells. Perry worked with his Houston doctor and a state representative to write legislation intended to commercialize the therapy in Texas.

In April, the Texas Medical Board approved rules regulating the therapy, which isn't approved by the FDA. The rules allow doctors to use stem cells as long as they get the approval of a review board that evaluates clinical research for safety. The board members were all appointed by Perry.

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Stem cell transplantation into mouse cochlea may impact future hearing loss therapies

June 27th, 2012 3:22 am

Public release date: 26-Jun-2012 [ | E-mail | Share ]

Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Putnam Valley, NY. (June 26 , 2012) Researchers in Japan who evaluated the risks and efficacy of transplanting two varieties of stem cells into mouse cochlea have concluded that both adult-derived induced pluripotent stem (iPS) cells and mouse embryonic stem (ES) cells demonstrate similar survival and neural differentiation capabilities. However, there is a risk of tumor growth associated with transplanting iPS cells into mouse cochleae. Given the potential for tumorigenesis, they concluded that the source of iPS cells is a critical issue for iPS cell-based therapy.

Their study is published in a recent issue of Cell Transplantation (21:4), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/,

"Hearing loss affects millions of people worldwide," said Dr. Takayuki Nakagawa of the Department of Otolaryngology, Graduate School of Medicine, Kyoto University, Japan. "Recent studies have indicated the potential of stem-cell based approaches for the regeneration of hair cells and associated auditory primary neurons. These structures are essential for hearing and defects result in profound hearing loss and deafness."

The authors noted that embryonic stem cells have previously been identified as promising candidates for transplantation, however they have also been associated with immune rejection and ethics issues. Consequently, this study compared the survival and neural differentiation capabilities of ES and three clones of mouse iPS cells.

"Our study examined using induced pluripotent stem cells generated from the patient source to determine if they offer a promising alternative to ES cells," explained Dr. Nakagawa. "In addition, the potential for tumor risk from iPS cells needed clarification."

Four weeks after transplantation, the researchers found that the majority of cochleae that had been transplanted exhibited the settlement of iPS or ES-derived neurons. However, there was a difference in the number of cells present based on cell lines. They noted that the number of cells able to be transplanted into cochleae is limited because of the cochleae's tiny size. Thus, the number of settled cells is low.

They also noted the formation of a teratoma (encapsulated tumor) in some cochlea after transplantation with one group of iPS cells.

"To our knowledge, this is the first documentation of teratoma formation in cochleae after cell transplantation," said Dr. Nakagawa.

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Harvard Bioscience plays role in stem cell transplants

June 27th, 2012 3:21 am

Harvard Bioscience, Inc. (Nasdaq: HBIO), a life sciences tools company, says the first two successful stem cells laryngotracheal transplants have been completed in Russia using the companys specially-designed bioreactor to grow the cells, which were taken from the patients bone marrow.

Last November, the Holliston, Mass.-based company announced that a simpler procedure, a tracheal transplant, had been completed using stem cells grown in the bioreactor. A few month later, the company announced that the recipient of the tracheal transplant, Christopher Lyle, had died.

The transplants, which required more than six months of preparation, were performed on the first two patients enrolled in an ongoing clinical trial at Krasnodar Regional Hospital in Russia. The company said the procedures are the result of a global collaboration involving organizations in the U.S., Sweden, Russia, Germany, and Italy. The patients were treated as part of a $4.8 million Russian government grant designed to foster international collaboration.

Both of the patients are under 35 and suffered severe damage to their tracheas due to car accidents and subsequent comas they sustained. The company said both patients were able to breathe and speak normally after the procedure.

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Bioheart Announces New Brand Image, Launches Redesigned Website and New Company Logo

June 27th, 2012 3:21 am

SUNRISE, Fla., June 26, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that the company has launched a new brand image and redesigned website including a new company logo and tagline aimed at increasing brand awareness and improving communications.

"It is an absolute necessity for biotechnology companies today to skillfully communicate consistent, cohesive messages to a variety of audiences and stakeholders," said Mike Tomas, Pres/CEO of Bioheart, Inc. "The new website is innovative, easy to navigate and furnishes value-added information and messaging."

The company's new tagline, Advancing Regenerative Medicine Solutions, accurately conveys its continued commitment to the development of effective cell technologies to treat cardiovascular diseases as well as harnessing true regenerative medicine which is the process of replacing or regenerating human cells, tissues or organs to restore or establish normal function. In addition to stem cell therapy, this can include cell enhancers, gene therapy, biologics, devices and more.

The main objective of the website redesign was to enhance the user experience for visitors and investors providing useful data about Bioheart's existing patents, the status of its clinical trials in the U.S. and Mexico, links to the company's Facebook and Twitter social media sites and the ability to sign-up for the company's e-newsletter. A Yahoo! Finance stock ticker has also been added to the investor section of the website.

The website redesign and new logo were developed by kabookaboo, an award-winning integrated marketing company that combines creative talent with strategic insight and online development with social media expertise (www.kabookaboo.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, or visit us on Facebook: Bioheart and Twitter @BioheartInc.

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.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

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FDA Criticizes Perry’s Stem Cell Lab

June 27th, 2012 3:20 am

HOUSTON (AP) - The U.S. Food and Drug Administration has issued a new report criticizing the Texas company that stored adult stem cells from Texas Gov. Rick Perry for use in an experimental procedure for his back pain, according to a newspaper report Monday.

An FDA report obtained by the Houston Chronicle said CellTex Therapeutics cannot guarantee the stem cells it takes from patients remain sterile and alive. The nine-page report dated April 27 says the lab, located in the Houston suburb of Sugar Land, does not have procedures to prevent contamination of products that are supposed to be sterile.

The report also says the lab didnt have written records of investigations into the failure of a batch of cells. It also says the lab has not marked some lab products properly.

The deficiencies identified reflect significant problems, serious issues, said Paul Knoepfler, an associate professor at the University of California-Davis School of Medicine, in an interview with the newspaper. If I were a patient, they would scare me off big time.

CellTex was thrust into the news last year when Perry, then running for the Republican nomination for president, revealed that he had stem cells taken from fat in his body, grown in a lab and then injected into his back during a July operation to address his back pain.

Perrys stem cells were stored and grown at CellTex, the Chronicle reported. The firm is co-owned by Dr. Stanley Jones, Perrys friend who performed the operation.

Subsequently, the Texas Medical Board approved new rules on similar experimental stem cell therapies. Perry appointed the board. The FDA has not approved any adult stem cell therapies for orthopedic use, but experimentation by doctors in the U.S. and abroad is common.

Some scientists tout possible benefits of stem cell treatments, including treatment for heart disease, diabetes and some cancers. Others argue adult stem cell experimentation actually increases the risk of cancer and can cause blood clots.

A Perry spokeswoman called Perrys surgery a success and reaffirmed his commitment to adult stem cell research. She said the FDA report was between the agency and CellTex.

CellTex CEO David Eller said the company invited the FDA inspection, which took place over nearly two weeks in April, according to the report.

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Bone marrow donors soon may be compensated

June 27th, 2012 3:19 am

A mother with three daughters who have Fanconi anemia sued the federal government for the right to compensate bone marrow donors. The U.S. Attorney General will not pursue the case with the Supreme Court, thus making a lower court's ruling law. That means bone marrow donors may now receive vouchers worth up to $3,000. NBC's Dr. Nancy Snyderman reports.

By JoNel Aleccia

Certain bone marrow donors could soon be compensated for their life-saving stem cells after federal officials declined to take the matter to the U.S. Supreme Court, allowing a lower court order to become law.

At least one agency, MoreMarrowDonors.org, hopes to begin a pilot program offering up to $3,000 in scholarships, housing vouchers or charity donations -- but not cash -- in exchange for matching donations of marrow cells derived from blood.

This decision is a total game-changer, said Jeff Rowes, a senior attorney with the Institute for Justice, which filed the lawsuit three years ago on behalf of cancer victims and others seeking bone marrow matches. Any donor, any doctor, any patient across the country can use compensation in order to get bone marrow donors.

That may be the effect of the decision by U.S. Attorney General Eric Holder to forgo a high court review of a 9th U.S. Circuit Court of Appeals ruling that certain kinds of bone marrow donations are exempt from federal rules banning compensation.

Under the ruling, donors who provide marrow cells through a process similar to blood donation, called peripheral blood stem cell apheresis, can be compensated because those cells are no longer regarded as organs or organ parts as defined in the National Organ Transplant Act.

The ruling does not apply, however, to bone marrow obtained through traditional techniques that use a needle to aspirate the cells from the hip.

Although it applies only to nine states covered by the 9th Circuit Court, Rowes expects the effects to be felt nationwide.

The move met with praise from Doreen Flynn, 36, of Lewiston, Maine, the lawsuits namesake and the single mother of three daughters with an incurable blood disorder called Fanconi anemia.

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Magnet helps target transplanted iron-loaded cells to key areas of heart

June 27th, 2012 3:19 am

Optimal stem cell therapy delivery to damaged areas of the heart after myocardial infarction has been hampered by inefficient homing of cells to the damaged site. However, using rat models, researchers in France have used a magnet to guide cells loaded with iron oxide nanoparticles to key sites, enhancing the myocardial retention of intravascularly delivered endothelial progenitor cells.

The study is published in a recent issue of Cell Transplantation (21:4), now freely available online.

"Cell therapy is a promising approach to myocardial regeneration and neovascularization, but currently suffers from the inefficient homing of cells after intracavitary infusion," said Dr. Philippe Menasche of the INSERM U633 Laboratory of Surgical Research in Paris. "Our study was aimed at improving and controlling homing by loading human cord-blood-derived endothelial progenitor cells (EPCs) for transplant with iron oxide nanoparticles in order to better position and retain them in the hearts of myocardial-injured test rats by using a subcutaneously implanted magnet."

The researchers found that the cells were sufficiently magnetic to be able to be remotely manipulated by a magnet subsequent to implantation.

According to the researchers, an objective assessment of the technique to enhance the homing of circulating stem cells is the ability to track their fate in vivo. This was accomplished by visualization with MRI.

"We found a good correlation between MRI non-invasive follow-up of the injected cells and immunofluoresence or quantitative PCR data," said Dr. Menasche. The researchers concluded that further studies were needed to follow cell homing at later time points. They noted that the magnitude of homing they experienced may have been reduced by the relatively small number of cells used, owing to their large size and the subsequent risk of coronary thrombosis.

"In a rat model of myocardial infarction, this pilot study suggested homing of circulating stem cells can be improved by magnetic targeting and warrants additional benchwork to confirm the validity of concept," said Dr. Menasche. "There is also a need to optimize the parameters of targeting and assess the relevance of this approach in a clinically relevant large animal model."

"This study highlights the use of magnets to target transplanted cells to specific sites which could increase their regenerative impact. Factors to still be extensively tested include confirming the safety of the cells containing the magnetic particles and whether this process alters the cell's abilities" said Dr. Amit N. Patel, director of cardiovascular regenerative medicine at the University of Utah and section editor for Cell Transplantation.

More information: Chaudeurge, A.; Wilhelm, C.; Chen-Tournoux, A.; Farahmand, P.; Bellamy, V.; Autret, G.; Mnager, C.; Hagge, A.; Larghro, J.; Gazeau, F.; Clment, O.; Menasch, P. Can Magnetic Targeting of Magnetically Labeled Circulating Cells Optimize Intramyocardial Cell Retention? Cell Transplant. 21 (4):679-691; 2012.

Journal reference: Cell Transplantation

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Bio-Matrix Scientific Group, Inc. Recruits Senior Scientist for Its Regen BioPharma Subsidiary

June 26th, 2012 2:17 pm

SAN DIEGO, CA--(Marketwire -06/26/12)- Bio-Matrix Scientific Group, Inc. (BMSN) (BMSN) announced today Thomas E. Ichim, PhD has joined the management team of its Regen BioPharma, Inc. subsidiary as Chief Scientific Officer and Director of Research. Regen BioPharma is the company's translational medicine platform for the rapid commercialization of stem cell therapies.

Dr. Ichim is one of the leading authorities in the world on stem cell biology. To date, he has published 82 peer-reviewed articles and is co-editor of the textbook RNA Interference: From Bench to Clinical Translation. He is also inventor on over 30 patents and patent applications. He currently serves as the CEO of Medistem, Inc., was formerly chief of scientific development, and is the scientific founder / co-founder of Medvax Pharma, ToleroTech, bioRASI, and OncoMune.

David Koos, Chief Executive Officer of Bio-Matrix Scientific Group, stated: "Dr. Ichim is a seasoned biotechnology executive with a track record of scientific excellence. We now have a world-class team to lead our efforts to commercialize stem cell therapies."

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

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

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

Disclaimer

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

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FDA report faults Houston-area stem-cell company

June 26th, 2012 2:17 pm

The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration.

In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.

"You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive.

The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law.

The report, partially redacted, was not accompanied by a warning letter.

A former FDA official who read it, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut down if it does not remedy the problems quickly. The former official asked not to be identified.

Adult stem cells are cells in the body that multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have shown promise for tissue repair in many other diseases in the last decade, although most scientists in the field consider them not ready for mainstream use.

Rules take effect Friday

Celltex has been in the public eye since it was revealed that Perry's Houston doctor treated him with his own stem cells during back surgery last July and in follow-up appointments. His stem cells were stored and grown at Celltex.

Perry subsequently called for Texas to become the nation's leader of adult stem cell medicine, which he touts as an ethical alternative to embryonic stem cells. Perry worked with his Houston doctor and a state representative to write legislation intended to commercialize the therapy in Texas.

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FDA report faults Houston-area stem-cell company

June 26th, 2012 1:12 pm

The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration.

In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.

"You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive.

The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law.

The report, partially redacted, was not accompanied by a warning letter.

A former FDA official who read it, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut down if it does not remedy the problems quickly. The former official asked not to be identified.

Adult stem cells are cells in the body that multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have shown promise for tissue repair in many other diseases in the last decade, although most scientists in the field consider them not ready for mainstream use.

Rules take effect Friday

Celltex has been in the public eye since it was revealed that Perry's Houston doctor treated him with his own stem cells during back surgery last July and in follow-up appointments. His stem cells were stored and grown at Celltex.

Perry subsequently called for Texas to become the nation's leader of adult stem cell medicine, which he touts as an ethical alternative to embryonic stem cells. Perry worked with his Houston doctor and a state representative to write legislation intended to commercialize the therapy in Texas.

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BioCells (Argentina) and Cord Blood America, Inc. Reach Agreement on Payments

June 26th, 2012 1:12 pm

LAS VEGAS, June 25, 2012 /PRNewswire/ -- Cord Blood America, Inc. (OTC BB: CBAI) is pleased to announce it has finalized an Agreement with the individuals from whom CBAI acquired its majority interest in BioCordcell (BioCells) Argentina, S.A. regarding the 2011 earn-out, previously in dispute as disclosed in the Company's most recent 10Q and 10K filings.

The terms of the Agreement limit the cash payout to the sellers during 2012 to $60,000. Additionally, the Agreement provides for future cash amounts, not to exceed $440,000, to be paid through CBAI's percentage portion of dividends earned solely based on BioCells' operating performance in 2012 and 2013. This structure should also reverse a portion of the previous accrual related to the 2011 earn-out amount on the balance sheet booked for year ending 2011, and negates any further balance sheet liability which could have been recorded upwards of $455,000 if no such agreement was reached.

"I am most pleased that the sellers of BioCells, through Diego Rissola, President of BioCells, and Cord Blood America management were not only able to reach an agreement on the final year of the earn-out, but also use the extensive dialogue to strengthen several components of the relationship that will leverage the two entities in the years ahead," said Chairman and President Joseph Vicente.

Mr. Vicente in addition said:

"It is exciting to see the ever increasing recognition by the Latin American population of the value of storing stem cells. We believe our relationship with BioCells places us in a unique position to continue to expand our knowledge and presence in South America and Central America for this growing population, as we also continue to expand our efforts in reaching the Hispanic population in the United States," Mr. Vicente concluded.

About Cord Blood America

Cord Blood America, Inc. is the parent company of CorCell Companies, Inc., which facilitates umbilical cord blood stem cell preservation for expectant parents and their children. Its mission is to be the most respected stem cell preservation company in the industry. Collected through a safe and non-invasive process, cord blood stem cells offer a powerful and potentially life-saving resource for treating a growing number of ailments, including cancer, leukemia, blood, and immune disorders. To find out more about Cord Blood America, Inc. and CorCell Companies, Inc., visit our websites: http://www.corcell.com/ for customer information and http://www.cordblood-america.com/ for investor information.

Forward-Looking Statements

Some statements made in this press release are forward-looking statements, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We use words such as "anticipate," "believe," "expect,'' "future," "intend," "plan," and similar expressions to identify forward-looking statements. These statements including those related to the growth of the industry, new stem cell treatments, and the Cord Blood America's performance, are only predictions and are subject to certain risks, uncertainties and assumptions. Additional risks are identified and described in the Company's public filings with the Securities and Exchange Commission. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company's past performance is not necessarily indicative of its future performance. The Company does not undertake, and the Company specifically disclaims any obligation to update any forward-looking statements to reflect occurrences, developments, events, or circumstances after the date of such statement.

CONTACT: Paul Knopick E & E Communications 949/707-5365 pknopick@eandecommunications.com

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Photo Release — Harvard Bioscience's "InBreath" Bioreactors Used in World's First Successful Regenerated …

June 26th, 2012 1:12 pm

HOLLISTON, Mass., June 26, 2012 (GLOBE NEWSWIRE) -- Harvard Bioscience, Inc. (HBIO), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine, announces that its "InBreath" bioreactors were used for the world's first and second successful laryngotracheal implants, using synthetic laryngotracheal scaffolds seeded with cells taken from the patients' bone marrow. The surgeries took place at Krasnodar Regional Hospital in Krasnodar, Russia on June 19th and June 21st. The recipients of the implants, Julia T. and Aleksander Z., are recovering well. The implants in the procedures were grown in bioreactors developed by the regenerative medicine device business of Harvard Bioscience.

The transplants, which required more than a half-year of preparation, were performed on the first two patients enrolled in an ongoing clinical trial at Krasnodar Regional Hospital. The Russian Ministry of Health has approved a clinical protocol for an unlimited number of patients in this trial, all of which will involve trachea procedures.

Each bioreactor was specifically adapted by Harvard Bioscience to the clinical requirements for each patient. Each bioreactor was loaded with a synthetic scaffold in the shape of the patient's original organ. The scaffolds were then seeded with the patient's own stem cells. Over the course of about two days, the bioreactor promoted proper cell seeding and development. Because the patients' own stem cells were used, their bodies have accepted the transplants without the use of immunosuppressive drugs.

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13437

The procedures are the result of a global collaboration involving organizations in the US, Sweden, Russia, Germany, and Italy:

-- The bioreactors were developed, manufactured and prepared by teams at Hugo Sachs Elektronik, a German subsidiary of Harvard Bioscience and at Harvard Bioscience, based in Massachusetts, U.S.A.

-- The scaffolds were created by US-based Nanofiber Solutions.

-- The principal transplant surgeon and main coordinator for both procedures was Dr. Paolo Macchiarini, Professor of Regenerative Surgery at Karolinska Institute in Stockholm.

-- Dr. Macchiarini was assisted by a team of surgeons including Dr. Vladimir Porhanov, Chief Doctor of Krasnodar Regional Hospital and head of the Oncological and Thoracic Department of Kuban State Medical University; thoracic surgeons Dr. Igor Polyakov and Dr. Nikolay Naryzhnyi, of Krasnodar Regional Hospital; Dr. Anatoly Zavrazhnov, deputy chief of Krasnodar Regional Hospital; and Dr. Sergey Sitnick, anesthesiologist and head of Krasnodar Regional Hospital's intensive care unit.

-- Dr. Alessandra Bianco at University of Rome, Tor Vergata, performed mechanical testing during scaffold development.

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Photo Release -- Harvard Bioscience's "InBreath" Bioreactors Used in World's First Successful Regenerated ...

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Immune Design Corp. Announces Appointment of Dr. Roger Perlmutter as a Member of Its Board of Directors

June 26th, 2012 1:11 pm

SEATTLE, June 26, 2012 (GLOBE NEWSWIRE) -- Immune Design Corp. announced today the appointment of Roger M. Perlmutter, M.D., Ph.D., as a member of its Board of Directors. Dr. Perlmutter recently served as the Executive Vice President, Research and Development, at Amgen Inc., where he oversaw the company's worldwide research and development operations.

"On behalf of Immune Design, I want to welcome Roger as a new member of the Board of Directors. As both an internationally recognized executive leader in the Pharmaceutical and Biotechnology industry and as an accomplished academician in the field of Immunology and Biology, his appointment will further strengthen our company and our quest of shaping the immune system to develop novel immune therapies that we are developing at Immune Design," commented Dr. Carlos Paya, Immune Design's Chief Executive Officer.

"Immune Design has advanced a pioneering approach towards the development of new prophylactic and therapeutic vaccines," stated Dr. Perlmutter. "I look forward to working more closely with the board and management at Immune Design, and welcome this opportunity to help transform vaccine development in the years to come."

Dr. Perlmutter served as Executive Vice President for Research and Development at Amgen, Inc. from 2001 until 2012, where he led the registration efforts for numerous new drugs including Sensipar(TM), Prolia(TM) Nplate(TM) and Xgeva(TM). Prior to joining Amgen, Dr. Perlmutter was for many years Professor and Chairman of the Department of Immunology at the University of Washington in Seattle, and an Investigator of the Howard Hughes Medical Institute. He also served at Merck & Co. from 1997 to 2001, including as Executive Vice President for Worldwide Discovery and Preclinical Research.

Dr. Perlmutter is member of the American Academy of Arts and Sciences, an elected Fellow of the American Association for the Advancement of Science, and is a director of StemCells, Inc. (STEM) and the Institute for Systems Biology. A graduate of Reed College, Portland, OR., and current chairman of the Reed College Board of Trustees, Dr. Perlmutter received his M.D. and Ph.D. degrees from Washington University, St. Louis, Mo. in 1979.

About Immune Design Corp.

Immune Design is a privately held, clinical-stage biotechnology company based in Seattle, Washington, and formed in 2008 to bring together some of the world's leaders in the field of molecular immunology to develop vaccines for the treatment and prevention of infectious and malignant disease. The company employs advanced and leading edge methods to precisely control the activation and context of antigen presentation by dendritic cells in order to shape the desired adaptive immune response. This goal is accomplished through the application of two proprietary technology platforms that activate the immune system by distinct mechanisms.

Additional information can be found on the company's website at http://www.immunedesign.com.

The Immune Design logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13428

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