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Regenerative medicine pioneer continues changing lives with first successful laryngotracheal implants

June 28th, 2012 11:20 am

Harvard Bioscience's "InBreath" Bioreactors Used in World's First Successful Regenerated Laryngotracheal Transplants

First Two Transplants Performed in Government-Approved Clinical Trial in Russia

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.

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Celltex Responds to Media Reporting on FDA Visit

June 28th, 2012 11:20 am

HOUSTON, June 27, 2012 /PRNewswire/ --After an invitation from Celltex Therapeutics Corp., the Food and Drug Administration (FDA) visited the Celltex laboratory for two weeks in April, 2012. TheFDA studied Celltex operations in depth in accordance with the "good tissue practices" (GTP) standards, as it routinely does with inspections of facilities such as Celltex which are registered pursuant to 21 CFR Part 1271. In their close-out report given to Celltex on the last day of their visit, the FDA had 14 main observations that it requested Celltex resolve.

Celltex has worked closely withtheFDA both during its visit and since to provide requested details and documentationto answer its questions. We have resolved many of the FDA observations, and we are working to address the remainder. We have an open line of communication with the FDAand expect to maintain that in our cooperative relationship.

Celltex continues to provide stem cell banking and multiplication services without interruption and has not received any disciplinary action from the FDA.

Celltex's laboratory is currently operated by its licensing partner RNL Bio (dba Human Biostar), with lab technicians and scientists from RNL's Seoul, Korea headquarters. The main issues in the FDA observations arose from a language barrier. RNL scientists extensively document procedures, including validations, but they are recorded in Korean and were not able to be provided in English to FDA during its visit. Since the FDA's visit, the RNL procedures and other documents have been translated to English by an independent, professional translation service, and supplied to the agency. We are confident that the translated documents demonstrate the thoroughly validated scientific process that underpins the Celltex laboratory operations.

Celltex continues to strengthen its documentation and laboratory operations and has added to its staff Celltex personnel experienced in U.S. FDA compliance.

Some media reports and social media chatter suggest that Celltex is somehow acting illegally or providing unapproved treatments. These statements are inaccurate. Celltex is registered with the FDA as a facility that multiplies human cells and cellular products (HCT/Ps); in particular, adult mesenchymal stem cells. The FDA does not require a company to obtain FDA approval prior to distribution of its HCT/Ps. 21 CFR Part 1271. In addition, the FDA does not issue "licenses," so any reference that Celltex provides "unlicensed" procedures is inaccurate. Celltex's process for reproducing adult mesenchymal stem cells is legal, and there is no requirement that the cells be approved or licensed.

Celltex ensures that all of the cells it provides to physicians for therapeutic use are sterile, viable, intact mesenchymal stem cells. RNL's quality control scientists examine each patient's cells for their integrity and sterility prior to release, documenting those findings. Celltex and its partner RNL Bio process stem cells in a safe, sterile laboratory with procedures that ensure cell viability and integrity.

Celltex has taken the initiative to make autologous adult mesenchymal stem cell multiplication services available to physicians outside of academia for use with their patients. Celltex firmly believes in the great therapeutic potential for autologous mesenchymal stem cell multiplication services in regenerative medicine.

For more information, contact Celltex, 713-590-1000.

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Diabetes Reversed In Mice Thanks To Stem Cell Transplant

June 28th, 2012 11:19 am

Canadian scientists were able to reverse diabetes in mice with a human stem cell transplant, igniting hopes for a cure for the widespread disease -- caused by the failure of the pancreas to produce enough insulin to stabilize blood sugar levels -- in humans.

A paper outlining the work, led by Timothy Kieffer of the University of British Columbia and conducted in partnership with New Jersey-based company BetaLogics, appeared in the journal Diabetes on Tuesday.

Diabetic mice were weaned off of insulin after receiving the pancreatic stem cell transplant, which restarted the cycle in which insulin production rises or falls based on blood sugar levels. Three to four months later, the mice could maintain healthy blood sugar levels even after being fed a lot of sugar.

"We are very excited by these findings, but additional research is needed before this approach can be tested clinically in humans," Kieffer said in a statement on Tuesday.

The researchers cautioned that their study used mice that had a suppressed immune system, the better to prevent rejection of the transplanted cells.

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"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," Kieffer said.

In 2009, a different team of researchers led by scientists from the University of Sao Paulo in Brazil and Northwestern University reported in the Journal of the American Medical Association that they were able to successfully reverse type 1 diabetes by injecting 8 patients with some of their own stem cells.

Some studies have shown that this kind of stem cell transplantation is only a temporary fix - after anywhere between six months to three years, the insulin-producing cells are again attacked by the patient's immune system.

SOURCE: Rezania et al. "Maturation of Human Embryonic Stem Cell-Derived Pancreatic Progenitors into Functional Islets Capable of Treating Pre-existing Diabetes in Mice." Diabetes 27 June 2012.

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The Pontifical Council for Culture and the Stem for Life Foundation Present Groundbreaking Book on Adult Stem Cell …

June 27th, 2012 10:10 pm

VATICAN CITY, Italy, June 27, 2012 (GLOBE NEWSWIRE) -- Today, as part of an ongoing mission to advance scientific research on adult stem cell therapies and explore their cultural and ethical implications, Monsignor Tomasz Trafny of the Vatican's Pontifical Council for Culture, joined Dr. Robin Smith, CEO of NeoStem (NYSE MKT:NBS) and Chairman and President of the Stem for Life Foundation, and Dr. Max Gomez, trustee of the Stem for Life Foundation, to present the first copy of their forthcoming book, Our Stem Cells: The Mystery of Life and Secrets of Healing, to The Holy Father, Pope Benedict XVI.

The book is the result of a unique collaboration between the Vatican's Pontifical Council for Culture (via its charitable foundation STOQ International) and the Stem for Life Foundation, and will be available later this year. It includes a special address by His Holiness Benedict XVI, urging increased support and awareness for advancements in adult stem cell research in order to alleviate human suffering.

The book focuses on concepts discussed at the First International Vatican Adult Stem Cell Conference (2011) and presents the reader with an engaging, comprehensive overview of adult stem cells and their vital role in a future of regenerative medicine. In powerful, accessible language the book showcases a wide array of emerging adult stem cell breakthroughs, including their ability to repair damaged hearts and organs, restore sight, kill cancer, cure diabetes, heal burns and stop the march of degenerative diseases, such as Alzheimer's, multiple sclerosis and Lou Gehrig's disease.

"In addition to making the science easy to understand, we filled the book with here-and-now case studies on how adult stem cell therapies are already helping real people suffering needlessly from deadly and debilitating diseases and medical conditions," said Dr. Smith. "Not only does the book speak to the success of our historic partnership with the Vatican, but it sets the stage for our next events."

"This book promotes a powerful dialogue between scientific and religious communities," said Monsignor Tomasz Trafny. "This dialogue needs to find its expression within the important framework of searching for truth and being guided by the highest ethical values. We hope this book will help educate people throughout the world regarding the importance of ethical scientific research and help them understand they do not need to choose between their faith and science; but in fact, the two can work together to profoundly improve humanity."

To preorder the book, go to: http://www.stemforlife.org/ourstemcells

About the Stem for Life Foundation

Stem for Life Foundation (SFLF) is dedicated to improving the quality of life of millions of people suffering from dozens of painful and sometimes debilitating medical conditions by providing information and updates about adult stem cell research, therapy development and possible healthcare applications. SFLF focuses on educating the public, convening the best minds in adult stem cell medicine and research, supporting clinical research, and subsidizing adult stem cell collection and storage for those who need it most.

Understanding that adult stem cell research could lead to better treatments and possibly cures for chronic disease, as well as reduce health care costs and improve quality of life for those with chronic disease and disability, SFLF was established in 2007. SFLF's Board of Trustees and staff are deeply committed to expediting development of stem cell therapies that offer real hope to individuals suffering from a wide-range of life-threatening medical conditions.

About The Pontifical Council for Culture

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FDA report faults Houston stem-cell company

June 27th, 2012 10:10 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 asked not to be identified, 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.

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 July 8

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

June 27th, 2012 10:10 pm

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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HemoGenix® FDA Master File to Measure Blood Stem Cell Potency for Cellular Therapy Products:

June 27th, 2012 10:10 pm

COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--

HemoGenix announced today that FDA CBER has given HemoGenix its first Master File Number for an in vitro blood stem cell potency, quality and release assay (HALO-96 PQR) (1)for cellular therapy products(2)used for stem cell transplantation purposes. HALO-96 PQR is the first commercially available stem cell potency assay for cellular therapy products. It incorporates the most sensitive readout available to measure changes in the cells energy source (ATP) as a function of the potential for stem cells to proliferate. Potency and quality of stem cell therapeutic products are required to be measured prior to use to help predict the engraftment of the cells in the patient. At the present time, tests such as cell number, viability and a stem cell marker called CD34 are routinely used. However, none of these tests specifically measure stem cells and none determine the stem cell biological activity required for a potency assay. The only cell functionality test presently used in this field, especially for umbilical cord blood transplantation, is the colony-forming unit (CFU) assay, which is subjective, non-validated and has been used since the early 1970s. HALO-96 PQR changes this paradigm. It is particularly needed in the umbilical cord blood stem cell transplantation field by providing an application-specific test incorporating all of the compliance characteristics required not only by regulatory agencies(3) and standards organizations, but also the cord blood community(4).

Stem cell potency is one of the most important parameters necessary for any therapeutic product, especially stem cells. Without it, the dose cannot be defined and the transplantation physician has no indication as to whether the product will engraft in the patient. The number of cord blood units collected and stored and the number of cord blood stem cell transplantations have increased exponentially over the last 12 years. During this time, significant advancements have been made in pre- and post stem cell transplantation procedures. Yet the tests used during the preparation and processing of the cells have remained unchanged and do not even measure the biological functionality of the stem cells being transplanted. Indeed, the standards organizations responsible for applying regulatory guidance to the community have so far failed to allow any new and alternative assays to be used during cord blood processing. HALO-96 PQR is the first test that actually quantitatively characterizes and defines the stem cells in cord blood, mobilized peripheral blood or bone marrow as high quality and potent active ingredients for release prior to transplantation. Presently, approximately 20% engraftment failure is encountered in cord blood transplantation. HALO-96 PQR could help reduce the risk of engraftment failure by providing valuable and time-sensitive information on the stem cells prior to use. HALO-96 PQR complies with the guidelines not only with the cord blood community, but also with regulatory agencies thereby providing a benefit to both the stem cell transplantation center and the patient, said Ivan Rich, Founder and CEO of HemoGenix (www.hemogenix.com).

About HemoGenix, Inc.

HemoGenix is a privately held Contract Research Service and Assay Development Laboratory based in Colorado Springs, Colorado. Specializing in predictive in vitro stem cell toxicity testing, HemoGenix provides its services to small, medium and many of the largest biopharmaceutical companies. HemoGenix has developed several assays for stem cell therapy and regenerative medicine applications. These and other patented and proprietary assays are manufactured and produced in Colorado Springs and sold worldwide. HemoGenix has been responsible for changing the paradigm and bringing in vitro stem cell hemotoxicity testing into the 21st century. With HALO-96 PQR the company is now also changing the paradigm to become a leader in stem cell therapy assays. To this end, HemoGenix is a member of the Alliance for Regenerative Medicine and working with other companies to decrease risk and improve safety for the patient.

Literature Cited

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Metformin Shows Promise For Pancreatic Cancer Patients

June 27th, 2012 9:14 pm

Editor's Choice Main Category: Pancreatic Cancer Also Included In: Cancer / Oncology;Stem Cell Research Article Date: 27 Jun 2012 - 10:00 PDT

Current ratings for: Metformin Shows Promise For Pancreatic Cancer Patients

3 (2 votes)

In combination with the standard chemotherapy for pancreatic cancer, metformin was observed to efficiently eradicate both cancer stem cells and more differentiated cancer cells that form the bulk of the tumor. The study was presented at the American Association for Cancer Research's Pancreatic Cancer: Progress and Challenges conference in Lake Tahoe, Nev., from June 18-21, 2012 by Christopher Heeschen, M.D., Ph.D., a professor for experimental medicine at the Spanish National Cancer Research Centre in Madrid.

Heeschen said that the majority of clinical trials of pancreatic cancer during the last 15 years failed to demonstrate a notable improvement in the average survival, which indicates for various reasons the methods used in these trials were insufficient. However, within the last few years, scientists have discovered cancer stem cells, which contrary to the cancer cells that make up the bulk of the tumor, consist of a small subset of cells that are resistant to conventional therapy.

He continued:

The team discovered that metformin-pretreated cancer stem cells proved especially sensitive to changes to their metabolism through the activation of AMPK, as metformin killed the cancer stem cells, but only stopped the cell's growth in more differentiated cancer cells.

Heeschen explained:

Their findings were supported in an experiment with mice, in which they treated immunocompromised mice that were implanted with various sets of patient-derived tumors with a combination of metformin and the standard chemotherapeutic treatment for pancreatic cancer, gemcitabine. The results were reduced tumors and a prevention of relapse in contrast to mice treated only with metformin or with gemcitabine.

Heeschen remarked: "Intriguingly, in all tumors treated with metformin to date, relapse of disease was efficiently prevented and there were no noticeable adverse effects."

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Regulation of telomerase in stem cells and cancer cells

June 27th, 2012 9:14 pm

ScienceDaily (June 27, 2012) Scientists at the Max Planck Institute of Immunobiology and Epigenetics in Freiburg have gained important insights for stem cell research which are also applicable to human tumours and could lead to the development of new treatments. As Rolf Kemler's research group discovered, a molecular link exists between the telomerase that determines the length of the telomeres and a signalling pathway known as the Wnt/-signalling pathway.

Telomeres are the end caps of chromosomes that play a very important role in the stability of the genome. Telomeres in stem cells are long and become shorter during differentiation or with age, but lengthen again in tumour cells.

The Wnt/-catenin signalling pathway controls numerous processes in embryonic development, such as the formation of the body axis and of organ primordia, and is particularly active in embryonic and adult stem cells. The -catenin protein plays a key role in this signalling pathway. The incorrect regulation or mutation of -catenin leads to the development of tumours.

Rolf Kemler's research group has now shown that -catenin regulates the telomerase gene directly, and has explained the molecular mechanism at work here. Embryonic stem cells with mutated -catenin generate more telomerase and have extended telomeres, while cells without -catenin have low levels of telomerase and have shortened telomeres.

This regulation mechanism can also be found in human cancer cells. These discoveries could lead to the development of a new approach to the treatment of human tumours.

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The above story is reprinted from materials provided by Max-Planck-Gesellschaft.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

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Successful transplant of patient-derived stem cells into mice with muscular dystrophy

June 27th, 2012 9:14 pm

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

Contact: Clare Ryan clare.ryan@ucl.ac.uk 44-203-108-3846 University College London

Stem cells from patients with a rare form of muscular dystrophy have been successfully transplanted into mice affected by the same form of dystrophy, according to a new study published today in Science Translational Medicine.

For the first time, scientists have turned muscular dystrophy patients' fibroblast cells (common cells found in connective tissue) into stem cells and then differentiated them into muscle precursor cells. The muscle cells were then genetically modified and transplanted into mice.

The new technique, which was initially developed at the San Raffaele Scientific Institute of Milan and completed at UCL, could be used in the future for treating patients with limb-girdle muscular dystrophy (a rare form in which the shoulders and hips are primarily affected) and, possibly, other forms of muscular dystrophies.

Muscular dystrophies are genetic disorders primarily affecting skeletal muscle that result in greatly impaired mobility and, in severe cases, respiratory and cardiac dysfunction. There is no effective treatment, although several new approaches are entering clinical testing including cell therapy.

In this study, scientists focused on genetically modifying a type of cell called a mesoangioblast, which is derived from blood vessels and has been shown in previous studies to have potential in treating muscular dystrophy. However, the authors found that they could not get a sufficient number of mesoangioblasts from patients with limb-girdle muscular dystrophy because the muscles of the patients were depleted of these cells.

Instead, scientists in this study "reprogrammed" adult cells from patients with limb-girdle muscular dystrophy into stem cells and were able to induce them to differentiate into mesoangioblast-like cells. After these 'progenitor' cells were genetically corrected using a viral vector, they were injected into mice with muscular dystrophy, where they homed-in on damaged muscle fibres.

The researchers also showed that when the same muscle progenitor cells were derived from mice the transplanted cells strengthened damaged muscle and enabled the dystrophic mice to run for longer on a treadmill than dystrophic mice that did not receive the cells.

Dr Francesco Saverio Tedesco, UCL Cell & Developmental Biology, who led the study, said: "This is a major proof of concept study. We have shown that we can bypass the limited amount of patients' muscle stem cells using induced pluripotent stem cells and then produce unlimited numbers of genetically corrected progenitor cells.

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Eternal optimist

June 27th, 2012 9:14 pm

A white earpiece connects to a cellphone atop a piece of Plexiglas surrounding her wheelchair. Her limp yet functional fingertips push the screen to accept a call one of many throughout the day from an ever-growing client base.

Novatos Abelina Magana, a mother of three teenagers, is an optimistic woman, a quality she says was essential in her survival, her recovery and her journey back to work in May.

Magana, 39, smiled as her caregiver wheeled her into her new home office, which is filled with paperwork, computers and a large whiteboard on the wall that lists potential clients. With seven escrows in the works, she focuses on four home listings, just weeks after restarting her career.

Five years ago Maganas husband gunned her down in an attempted murder-suicide, leaving her a quadriplegic. Shes amazed doctors by not only returning to her real estate career at Novato-based Frank Howard Allen Realtors but gaining mobility in her arms through controversial stem cell treatments.

She is so successful because she is a great agent, said Miguel Paredes, Maganas business partner. Its because people respect her and shes extremely intelligent.

Paredes assisted Magana on her first lease and has since eagerly committed to working with this woman who inspires him with her ambitious attitude.

She was rookie of the year and sold over 40 homes during her first year in 2002, Paredes said. Shes a fighter. Shes always had that reputation in the community.

Magana keeps motivated by biking eight miles a day with the help of an electric stimulator pad that forces her muscles to respond. Its part of a four-hour daily regimen of physical therapy. Shes also gained the use of both arms after undergoing two stem cell treatments in Panama.

Were at the beginning stages, but I know for a fact that it helps people, she said. It helped me.

The expensive treatments were made possible by local fundraising efforts. The first treatment cost $30,000, the second $21,000, and the final will cost $15,000. Travel and hotel expenses are not included.

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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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