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WWL-TV and Sally-Ann Roberts rally support for bone-marrow donor registry

By Sykes24Tracey

WWL-TVs Sally-Ann Roberts talks about her sisters health battle. Watch Richard Ford on The Colbert Report. TV tweet of the day so far.

TV Linkzilla Daily for 6/27/12 starts now.

When Good Morning America anchor Robin Roberts announced June 11 that shed been diagnosed with a rare form of bone-marrow cancer MDS, or myelodysplastic syndrome -- and would undergo chemotherapy and a bone-marrow transplant, her sister, WWL-TV anchor Sally-Ann Roberts, was cast in a key recovery role.

Sally-Ann Roberts, it turned out, was a perfect match to be a bone-marrow-cell donor for her sister. The New Orleans anchors medical contribution wont come for weeks or perhaps months, but shes already begun efforts to raise awareness of the need for donors.

Her station has launched a Perfect Match Supporting Sally-Ann & Robin page on its website, which now holds several stories on the topic, including a Wednesday (June 27) piece in which WWL staffers sign up to join a bone-marrow registry.

An informational and registration phone-bank, staffed by volunteers from organ- and bone-marrow-donation organizations, will operate from 6-9 p.m. Thursday (June 28), in coordination with the stations morning news block.

In a recent interview, Sally-Ann Roberts said her match is a real blessing, because only 25 percent of people who need a bone-marrow transplant actually find a match among their siblings.

She continued:

The majority of people who need a bone marrow donor have to go outside of their family in order to find one. Sometimes it's like a needle in a haystack, and that's why Robin wants to use this challenge that she's facing right now to try to bring attention to the national narrow donor registry. Millions of people are part of it. If a person -- man woman or child -- is in search of a bone marrow donor they can go to this registry and have a chance to find one. There are many, many people who have used the registry successfully.

The only problem is that minorities are underrepresented in the donor registry. Unlike organ donations, where it really doesn't matter what the ethnic background of an individual is for an organ donation, bone marrow for stem cells has to be aligned with the person's genetic makeup. And that's why if you're African American you will find a match with another African American. Native Americans, the same thing. So that's why every racial group needs to be represented in the marrow-donor registry. That's what were trying to do. Were trying to direct people to BeTheMatch.org. If they do, they'll get a packet in the mail and will be able to do a swab, just the inside of their cheek, and will get a self-addressed stamped envelope. They mail it back with the required information. They may get a phone call, they may never get a phone call. But people who have done so -- I've gone online to listen to some of their stories -- they feel so grateful that they were able to reach out and help another individual in need.

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Bone marrow donors may be compensated after ruling stands

By JoanneRUSSELL25

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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Bone marrow donors soon may be compensated

By Sykes24Tracey

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

By JoanneRUSSELL25

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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North Brunswick doctor appears on MTV show

By NEVAGiles23

Local orthopedic physician treated patient who was featured on True Life

BY JENNIFER AMATO

Staff Writer

Dr. Edward Magaziner NORTH BRUNSWICK A young woman named Tamara was suffering from chronic pelvic pain that was affecting her everyday life.

She had undergone two surgeries on her hips, since doctors determined the pain was the result of friction within her hip joints, or impingement that would cause the throbbing pain .

Having even more pain after her second surgery, she visited Dr. Edward Magaziner, medical director of The Center for Spine, Sports, Pain Management and Orthopedic Regenerative Medicine in North Brunswick, to undergo a process called prolotherapy.

Tamara was first filmed for MTVs True Life in 2010 and was featured in the Then and Now follow-up, which debuted on May 17.

In his practice, Magaziner treats spinal, joint, muscle and nerve pain and headaches. Pain management treatments include acupuncture, Botox injections, epidural injections, mesotherapy, trigger-point injections, therapeutic laser and spinal cord simulation. He also performs minimally invasive spinal surgery using endoscopic laserassisted devices.

The more state-of-the-art treatments are bio-regenerative, such as prolotherapy and platelet-rich protein (PRP), said Magaziner. They are effective, he said, because increased blood flow to an injured part of the body is a natural form of healing; concentrating the healing properties of the blood, such as stem cells and growth factors, at the direct site of an injury will enhance healing effects.

The body heals itself naturally when its injured. When there is an injury, theres a biological and chemical signal that is produced at the cellular level where the injury is, to attract platelets and growth factors and stem cells to the area. With a combination of these factors, the body has the ability to heal the injury, said Magaziner, a diplomate of the American Academy of Pain Management.

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Need a Bone? Grow Your Own!

By NEVAGiles23

In just a few years, you might be able to grow your own replacement bones from stem cells.

Using pieces of human or animal bone as scaffolds, a Columbia University team has grown more than 50 healthy bones from stem cells -- the largest approximately 2.5 inches long. Among other specimens, the researchers produced a cheek bone, a small part of a femur bone, and a complex temporomandibular joint (TMJ), which is located in front of each ear and allows for chewing, speaking and smiling.

Using custom-built bioreactors housed at Columbia's Biomedical Engineering Lab, the process currently takes three to five weeks, and the team is working on a faster turnaround.

If we could grow this bone, we could do anything else, professor Gordana Vunjak-Novakovic, who heads up the team, told FoxNews.com. Stem cells are very smart. They can make anything as long as you place them in the right conditions and send them the right signals.

While building the new bone matrix, the cells also break down and decompose the old scaffold. The end result is a fully regenerated bone.

It looks like bone, feels like bone and responds like bone, said Sidney Eisig, a mouth, jaw and neck surgeon who collaborates with the lab to provide data necessary for growing anatomically shaped bones.

- Columbia University professor Gordana Vunjak-Novakovic

Cells that we use are the cells that make bones in our body normally, Vunjak-Novakovic said of the mesenchymal stem cells which reside in the bone marrow. Theyre constantly making and breaking bone. Similar to human skin, bone tissue is very metabolically active and regenerates quickly, which is why broken bones are able to heal. Bone tissue is actually easier to make than certain types of muscle, Vunjak-Novakovic explained. For example, the heart muscle is not designed to regenerate and is much harder to grow.

To prepare the scaffolds, Vunjak-Novakovics team thoroughly washed the animal bone pieces: first with water, which removed 99 percent of cellular material, then with special detergents to clean water resistant surfaces, and finally with enzymes to remove residual DNA from the cells nuclei. The result was a porous non-identifiable bone that could serve as a scaffold for any bone graft, including human.

They are also experimenting with synthetic silk scaffolds supplied by Tufts University.

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Harvard Bioscience plays role in stem cell transplants

By raymumme

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

By Dr. Matthew Watson

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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FDA report faults Houston stem-cell company

By JoanneRUSSELL25

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

By LizaAVILA

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:

By daniellenierenberg

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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FDA report faults Houston-area stem-cell company

By Sykes24Tracey

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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First Patients Dosed in Ib Phase of Neuralstem's NSI-189 Trial in Major Depressive Disorder

By JoanneRUSSELL25

ROCKVILLE, Md., June 25, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that the first patients were dosed in Phase Ib of its ongoing trial to test the safety of NSI-189 in the treatment of major depressive disorder (MDD). NSI-189, the lead compound in Neuralstem's small molecule platform, is a proprietary new chemical entity that stimulates new neuron growth in the hippocampus, a region of the brain believed to be implicated in MDD as well as other diseases and conditions, such as chronic traumatic encephalopathy (CTE), Alzheimer's disease, anxiety, and post-traumatic stress disorder (PTSD). This is the first time the drug will be tested in patients with MDD, as Phase Ia was in healthy volunteers.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO)

"We are pleased to begin testing the safety of NSI-189 in depression patients," said Karl Johe, PhD, Neuralstem's Board of Directors and Chief Scientific Officer. "We believe it could help patients who suffer from depression via a new mechanism that does not seek to modulate brain chemistry, but rather stimulates new neuron growth in the hippocampus and increases hippocampal volume, thereby potentially addressing the problem at the source."

About NSI-189 Neuralstem's technology enables the creation of neural stem cell lines from many areas of the human CNS, including the hippocampus. The hippocampus is a part of the brain involved in memory and the generation of new neurons. It is also implicated in several major neurological and psychiatric diseases. From its hippocampal neural stem cell lines, Neuralstem has created virtually unlimited amounts of mature human neurons and glia in laboratory dishes. These can be used to mimic the natural brain environment in order to test drug effects.

Neuralstem has been engaged in a drug discovery program with these human hippocampal stem cell lines since 2000. In 2009, Neuralstem was granted U.S. patents on four first-in-class chemical entities that boost the generation of new neurons. NSI-189, the first of these to be in a clinical trial, significantly stimulates the generation of new hippocampal neurons (neurogenesis) in vitro and in animal models.

NSI-189 is the lead compound in Neuralstem's neurogenic small molecule drug platform, which the company plans to develop into orally administered drugs for MDD and other psychiatric and cognitive disorders as diverse as CTE, Alzheimer's disease, anxiety, and PTSD.

NSI-189 has been shown to stimulate neurogenesis of human hippocampus-derived neural stem cells in-vitro and in vivo. In healthy normal adult mice, NSI-189 stimulated neurogenesis in the hippocampus and significantly increased its volume, apparently by increasing its synaptic network after 28 days of daily oral administration. In mouse models of depression, NSI-189 significantly improved behavioral responses associated with depression. In humans, NSI-189 may reverse the human hippocampal atrophy seen in MDD and other disorders and reverse their symptoms. This program has received significant support from both the Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).

About the Trial The NSI-189/MDD trial is a randomized, double-blind, placebo-controlled, multiple-dose escalating trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effect of NSI-189 in the treatment of MDD. Phase Ia tested escalating doses of single administration of NSI-189 in healthy patients. Phase Ib is testing the safety of escalating doses of NSI-189 for 28 daily administrations in 24 depressed patients. The Phase Ib portion of the trial is expected to take approximately six months to complete.

About Neuralstem Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

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First Patients Dosed in Ib Phase of Neuralstem's NSI-189 Trial in Major Depressive Disorder

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Bioheart's Chief Science Officer Kristin Comella Presents at 10th Annual Meeting of International Society for Stem …

By JoanneRUSSELL25

SUNRISE, Fla., June 25, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that Kristin Comella, the company's Chief Science Officer presented at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan June 13 - 16, 2012. One of the world's premier stem cell research events, the ISSCR format includes international research and poster presentations from invited speakers, exceptional peer-to-peer learning and unparalleled networking opportunities.

Comella presented a poster on clinical applications of adipose or fat derived stem cells (ADSCs).

The ISSCR annual meeting serves as the largest forum for stem cell and regenerative medicine professionals from around the world. Through lectures, symposia, workshops, and events attendees experience innovative stem cell and regenerative medicine research, advances and what's on the horizon. The meeting features more than 1,000 abstracts, nearly 150 speakers and provides numerous networking and professional development opportunities and social events. For additional information, visit http://www.isscr.org.

Kristin Comella has over 14 years experience in corporate entities with expertise in regenerative medicine, training and education, research, product development and senior management including more than 10 years of cell culturing experience. She has made a significant contribution to Bioheart's product development, manufacturing and quality systems since she joined the company in September 2004.

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.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2011, and its Quarterly Report on Form 10-Q for the quarter ended March 30, 2012.

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Speeding Up Bone Growth by Manipulating Stem Cells

By daniellenierenberg

Newswise If you break a bone, you know you'll end up in a cast for weeks. But what if the time it took to heal a break could be cut in half? Or cut to just a tenth of the time it takes now? Qian Wang, a chemistry professor at the University of South Carolina, has made tantalizing progress toward that goal.

Wang, Andrew Lee and co-workers just reported in Molecular Pharmaceutics that surfaces coated with bionanoparticles could greatly accelerate the early phases of bone growth. Their coatings, based in part on genetically modified Tobacco mosaic virus, reduced the amount of time it took to convert stem cells into bone nodules from two weeks to just two days.

The key to hastening bone healing or growth is to coax a perfectly natural process to pick up the pace.

"If you break a rib, or a finger, the healing is automatic," said Wang. "You need to get the bones aligned to be sure it works as well as possible, but then nature takes over."

Healing is indeed very natural. The human body continuously generates and circulates cells that are undifferentiated; that is, they can be converted into the components of a range of tissues, such as skin or muscle or bone, depending on what the body needs.

The conversion of these cells called stem cells is set into motion by external cues. In bone healing, the body senses the break at the cellular level and begins converting stem cells into new bone cells at the location of the break, bonding the fracture back into a single unit. The process is very slow, which is helpful in allowing a fracture to be properly set, but after that point the wait is at least an inconvenience, and in some cases highly detrimental.

"With a broken femur, a leg, you can be really incapacitated for a long time," said Wang. "In cases like that, they sometimes inject a protein-based drug, BMP-2, which is very effective in speeding up the healing process. Unfortunately, it's very expensive and can also have some side effects."

In a search for alternatives four years ago, Wang and colleagues uncovered some unexpected accelerants of bone growth: plant viruses. They originally meant for these viruses, which are harmless to humans, to work as controls. They coated glass surfaces with uniform coverings of the Turnip yellow mosaic virus and Tobacco mosaic virus, originally intending to use them as starting points for examining other potential variations.

But they were surprised to find that the coatings alone could reduce the amount of time to grow bone nodules from stem cells. Since then, Wang and co-workers have refined their approach to better define just what it is that accelerates bone growth.

Over the course of the past four years, they've demonstrated that it's a combination of the chemistry as well as the topography of the surface that determines how long it takes a stem cell to form bone nodules. The stem cells are nestled into a nanotopgraphy defined by the plant virus, and within that nanotopography the cells make contact with the variety of chemical groups on the viral surface.

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Dr. Ulrich Friedrichson, MD,PHD – Cell Therapy Introduction – Video

By LizaAVILA

25-06-2012 00:49 ProGenaCell physicians provide advanced cellular therapy to patients suffering from all known degenerative diseases. For over 70 years cell therapy has been used safely and effectively in such diverse regions as the European Union, former USSR, Republic of China, Middle East, Pacific Rim, Central and South America, Baja California and more recently the United States under select clinical trials. ProGenaCell provides patients with autologous stem cells (patient's own cells), adult progenitor xenocells, and organ extracts & growth factors. These "cellular products" are delivered to physicians who have been approved to prescribe and administer cellular therapies to patients in need. All cellular products are lawfully manufactured, and regulated under strict European Union guidelines. Visit us:

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Dr. Ulrich Friedrichson, MD,PHD - Cell Therapy Introduction - Video

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TaiGen Biotechnology Out-Licensed China Rights of Novel Antibiotic, Nemonoxacin, to Zhejiang Medicine

By LizaAVILA

TAIPEI, June 25, 2012 /PRNewswire-Asia/ -- TaiGen Biotechnology Company, Limited ("TaiGen") and Zhejiang Medicine Company, Limited ("ZMC") today announced that they have signed an exclusive agreement to manufacture and commercialize nemonoxacin, a novel broad-spectrum antibiotic, in China (excluding Hong Kong, and Macau). Nemonoxacin is a novel broad-spectrum non-fluorinated quinolone antibiotic under development for respiratory infections. TaiGen will be responsible for completing the Phase 3 clinical trial for community acquired pneumonia ("CAP") in China. ZMC will be responsible for manufacturing, sales and marketing of nemonoxacin in China through its wholly-owned subsidiary, XinChang Pharmaceuticals. TaiGen will retain full development and commercialization rights outside the licensed territory including Taiwan, the United States, European Union, and Japan. Under the terms of the agreement, TaiGen will receive an upfront payment of US$ 8 million from ZMC and will receive additional milestones as well as royalties on product sales. The term of the agreement is 20 years.

Nemonoxacin has demonstrated efficacy and safety in CAP and diabetic foot infection in multinational and multi-center clinical trials conducted by TaiGen. In particular, nemonoxacin has excellent activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA. Nemonoxacin is taken once-a-day and available in both oral and intravenous formulations. Currently, TaiGen is completing a Phase 3 CAP trial with more than 500 patients from Taiwan and mainland China and expects to file new drug applications in Taiwan and mainland China simultaneously in early 2013.

China is one of the major antibiotic markets in the world. According to IMS, the sales of antibiotics in 2011 were approximately US$ 11 billion (RMB 68 billion) and account for almost 20% of the total pharmaceuticals sales. Rate of antibiotic resistant infections in China is among the highest in the world.

Mr. Li Chun Bo, Chairman of the ZMC, commented, "We are impressed with nemonoxacin's broad spectrum activity towards drug-resistant bacteria, in particular, MRSA, and excellent safety profile. We are excited to establish this partnership with TaiGen because of its reputation as a premier research-based biotech company in Asia. This partnership will break new ground for cross-strait collaboration in the pharmaceutical industry. Nemonoxacin will be a major addition to ZMC's antibiotic product line and significant profit driver".

Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen, said, "China is the world's fastest growing pharmaceutical market. It is poised to overtake Japan as the second largest pharmaceutical market. We are extremely please to establish our nemonoxacin partnership with ZMC, a first-class pharmaceutical company and major player in the Chinese antibiotics market. With nemonoxacin, TaiGen and ZMC together will bring new medicine to treat unmet medical needs in China. This partnership will not only set a new record for pharmaceutical licensing involving a Taiwanese and a mainland Chinese company but hopefully will also become a model of the future collaborations," Dr. Hsu also added, "With the conclusion of the partnership in China, we will actively pursue nemonoxacin licensing discussions in other territories such as European Union."

About Zhejiang Medicine

Zhejiang Medicine Company, Limited is a leading pharmaceutical company in China specializing in sales and distribution of pharmaceuticals and manufacturing of active pharmaceutical ingredients (vitamins and antibiotics). Its sales revenue in 2011 is US $740 million (RMB 4.8 billion). ZMC is a leader in the Chinese antibiotic market with levofloxacin, vancomycin, and teicoplanin in the product line. ZMC's Lai Li Xin, a branded levofloxacin, is one of the top selling antibiotics in China with 2011 sales exceeding US $110 million (RMB 735 million). In addition to pharmaceuticals sales, ZMC is also known for its manufacturing quality. Its vancomycin active pharmaceutical ingredient has obtained GMP qualification from US Food and Drug Administration (FDA) and exported to western countries. ZMC is publicly listed in the Shanghai Stock Exchange (600216) and has a market capitalization of RMB 11 billion.

About TaiGen Biotechnology

TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, mainland China. TaiGen has full discovery research capacity in Taiwan and clinical development in mainland China/Taiwan/US. In addition to nemonoxacin, TaiGen has two other in-house discovered new chemical entities in clinical development under IND with US FDA: TG-0054, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, in Phase 2 and TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection, in Phase 1. Both TG-0054 and TG-2349 are currently in clinical development in the US.

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TaiGen Biotechnology Out-Licensed China Rights of Novel Antibiotic, Nemonoxacin, to Zhejiang Medicine

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Research and Markets: Translational Regenerative Medicine – Oncology, CNS and Cardiovascular-Rich Pipeline Features …

By JoanneRUSSELL25

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/skdhnn/translational_rege) has announced the addition of the "Translational Regenerative Medicine - Oncology, CNS and Cardiovascular-Rich Pipeline Features Innovative Stem Cell and Gene Therapy Applications" report to their offering.

More Guidelines Needed to Grow Regenerative Medicine Market, Report Finds

Standardized research guidelines are needed to control and encourage the development of gene therapy and stem cell treatments, according to a new report by healthcare experts GBI Research.

The new report* shows how regenerative medicine is seen as an area with high future potential, as countries need ways to cope with the burden of an aging population.

The stem cell market alone is predicted to grow to around $5.1 billion by 2014, while gene therapy has also shown promise despite poor understanding of some areas of regenerative medicine and a lack of major approvals (the only approvals to date being made in Asia).

Up until now, securing research within clinics has been difficult, with a high number of failures and discontinuations throughout all phases of clinical study. Stem cell therapy uses bone marrow transplants as an established treatment method, but the development of the therapy into further applications and has not yet become common practice.

Similarly, tissue engineering has been successful in the areas of skin and bone grafts, but translation into more complex therapies has been an issue for researchers. Although scientific possibilities are ever-increasing, the true potential of regenerative medicine has yet to be demonstrated fully.

A desire to discover new and innovative technologies has encouraged governments in the UK and Singapore to focus directly on regenerative medicine as a future potential economy booster.

Companies Mentioned:

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NeoStem Awarded NIAID Research Grant for the Development of VSEL Technology for Radiation Exposure

By LizaAVILA

NEW YORK, June 25, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a cell therapy company, today announced that it has been awarded a two year grant totaling $595,252 for the "Development of Human, Autologous, Pluripotent Very Small Embryonic Like (VSELs) Stem Cells as a Countermeasure to Radiation Threat" from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). This peer reviewed grant was awarded to support research to be headed by Denis O. Rodgerson, Ph.D., Director of Stem Cell Science for NeoStem and Mariusz Ratajczak, M.D., Ph.D., who is the head of the Stem Cell Biology Program at the James Graham Brown Cancer Center at the University of Louisville and co-inventor of VSELTM Technology.

This award will fund studies to investigate the potential of very small embryonic-like stem cells as a countermeasure to radiological and nuclear threat. The product candidate, which is an autologous stem cell therapy derived from the patient's own stem cells, will be developed to rescue patients who have been exposed to radiation due to nuclear accident or terrorist threat and to treat cancer patients who have undergone radiation therapy and who consequently have compromised immune systems. The award includes $295,252 for the first year and $300,000 for the second year of the project.

Dr. Denis O. Rodgerson, Director of Stem Cell Science for NeoStem, said, "We are very excited to add radiation treatment to the growing list of indications for which our VSELTM Technology is being evaluated. Those exposed to acute high-dose radiation have compromised immune systems such that the virulence and infectivity of biological agents is dramatically increased. Death can occur within 1-6 weeks following radiation exposure. Currently there is only one intervention that saves a fatally irradiated person -- a rescue through stem cell transplantation. VSELs might be an ideal cell therapy to regenerate the body's immune system and repair other tissues damaged by radiation exposure. Most importantly, early studies show VSELs are resistant to lethal radiation which destroys other immune system restoring stem cells in the body, making autologous treatment post-exposure possible."

Dr. Robin L. Smith, Chairman and CEO of NeoStem, added, "NeoStem is pleased that the NIAID is funding this cutting edge technology that we hope will reinvent the treatment landscape for acute radiation syndrome. We plan to continue to pursue NIH SBIR grants to fund our VSEL technology platform development with non-dilutive capital."

About VSELTM Technology

NeoStem has a worldwide exclusive license to VSELTM Technology. Research by Dr. Mariusz Ratajczak, M.D., Ph.D., and others at the University of Louisville provides compelling evidence that bone marrow contains a heterogeneous population of stem cells that have properties similar to those of an embryonic stem cell. These cells are referred to as very small embryonic-like stem cells. This finding opens the possibility of capturing some of the key advantages associated with embryonic stem cells without the ethical or moral dilemmas and without some of the potential negative biological effects associated with stem cells of embryonic derivation. The possibility of autologous VSEL treatments is yet another important potential benefit to this unique population of adult stem cells. VSELTM Technology offers the potential to go beyond the paracrine effect, yielding cells that actually differentiate into the target tissue creating true cellular regeneration.

About NeoStem, Inc.

NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and Amorcyte is enrolling patients for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2012/2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.

For more information on NeoStem, please visit http://www.neostem.com.

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Biotechnology Institute Leads Effort to Bring Life Science Education … – EON: Enhanced Online News (press release)

By Dr. Matthew Watson


EON: Enhanced Online News (press release)
Biotechnology Institute Leads Effort to Bring Life Science Education ...
EON: Enhanced Online News (press release)
The Biotechnology Institute announces today the formation of the nationally coordinated effort of state bioscience organizations.

Source:
http://news.google.com/news?q=biotechnology&output=rss

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