13-01-2012 08:41 This is human heart muscle in a dish, beating spontaneously. It was made by Dr Lei Ye of the Stem Cell Institute from human induced pluripotent stem cells (hiPSC). These were made by our iPSC facility from human skin cells into which 4 specific genes were temporarily introduced. The heart muscle cells were enabled to develop from the iPSC using a special medium and substrate. It is hoped to use cells like this for the treatment of heart disease by replacing heart muscle that has been destroyed.

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Human heart muscle in a dish, beating spontaneously. - Video

16-01-2012 16:52 On October 1st, 2009 I was diagnosed with Leukemia. After 9 months of intense chemotherapy treatments, the decision was made that I would need a bone marrow transplant. A suitable donor was not found within my family so I would have to rely on the national Be The Match® marrow registry to locate one for me. A match was found and on August 18th, 2010 I underwent a stem-cell transplant using an unrelated donors stem-cells. Today, I'm cancer free! Her generosity and selflessness has allowed me to call myself a 'survivor'. This video was captured of my donor and I meeting face-to-face for the first time. It was truly an amazing experience! I have made it my life's mission to 'Pay it Forward'. After transplant, I started working for The Leukemia and Lymphoma Society where I am able to use my wounds for good on a daily basis. My diagnoses was not in vain! To learn how you can help create a world without cancer, visit http://www.LLS.org and to join the Be The Match® registry, visit join.marrow.org

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Leukemia Survivor Meets His Bone Marrow Donor - Video

A new study by collaborating researchers at the University of Miami Miller School of Medicine and L’Institut du Thorax in Nantes, France, indicates that stem cells derived from cardiac tissue are far more effective in repairing damage caused by a heart attack than therapies using stem cells taken from bone marrow. The study, published today in STEM CELLS Translational Medicine, suggests that human fetal cardiac-derived c-kit+ stem cells (CSCs) can be 30 times more potent than bone marrow mesenchymal stem cells (MSCs) for treating a heart attack.

Durham, NC (PRWEB) February 07, 2012

A new study by collaborating researchers at the University of Miami Miller School of Medicine and L’Institut du Thorax in Nantes, France, indicates that stem cells derived from cardiac tissue are far more effective in repairing damage caused by a heart attack than therapies using stem cells taken from bone marrow. The study, published today in STEM CELLS Translational Medicine, suggests that human fetal cardiac-derived c-kit+ stem cells (CSCs) can be 30 times more potent than bone marrow mesenchymal stem cells (MSCs) for treating a heart attack.

As both of these cell types are currently in clinical trials, these results are significant because they are the first direct comparison of their therapeutic capability in vivo, the researchers say.

“This research — showing that CSCs can be 30 times more potent than MSCs — is significant because it can impact the design of future clinical trials,” said Dr. Anthony Atala, director of the Wake Forest Institute of Regenerative Medicine and editor of STEM CELLS Translational Medicine. “The results from the study, one of a few to compare efficacy, have the potential to make the translation process more efficient, speeding the development of new effective therapies.”

The researchers conducted their study using mice models with induced acute myocardial infarction. The mice then received human fetal CSCs or either an equivalent (low dose) or ~30-fold greater number (high dose) of MSCs. Cells were injected immediately after the attack. A control group received PBS. The researchers performed additional experiments to address whether adult CSCs are as efficient as fetal CSCs. The fetal stem cells outperformed the adult-cultured CSCs, as expected; still, the researchers concluded that the latter were more potent than high-dose MSCs in treating a heart attack.

The animals were then evaluated at various intervals over a period of eight weeks. The results showed that the CSCs improved the left ventricle, which had been enlarged by the heart attack, plus lowered the ejection fraction. While the high doses of the MSCs showed similar results, the low-doses of MSCs had no effect.

“This study was motivated by the huge advances occurring in the translation of stem cell therapeutics for heart disease,” said Dr. Joshua Hare, senior author of the study and director of UM’s Interdisciplinary Stem Cell Institute. “While many candidate therapies are being considered there are few studies comparing relative efficacy. This study shows that tissue specific cardiac stem cells are highly potent, but that bone marrow stem cells are also efficacious. We hope these results will help guide future clinical trials of cell-based therapy for heart disease.”

In addition, said Dr. Behzad Oskouei of UM’s Interdisciplinary Stem Cell Institute, “All cell therapies studied improved myocardial contractility, but the CSCs preferentially reduced scar size and vascular afterload. Engraftment and trilineage [cardiomyocyte, vascular smooth muscle, endothelial cell] differentiation was also substantially greater with CSCs than with MSCs.”

“It is clear that CSCs are superior in this regard and have potential advantages over MSCs to promote repair following ischemic heart damage. Furthermore, they are effective at a surprisingly low-dose/efficacy ratio,” Dr. Oskouei noted. “These findings offer key new insights into the cellular characteristics underlying successful cell-based cardiac repair.”

About AlphaMed Press: Established in 1983, AlphaMed Press with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes two other internationally renowned peer-reviewed journals: STEM CELLS® (http://www.StemCells.com), celebrating its 30th anniversary in 2012, is the world's first journal devoted to this fast paced field of research. The Oncologist® (http://www.TheOncologist.com), also a monthly peer-reviewed publication, entering its 17th year, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. All three journals are premier periodicals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines.

###

Sharon Lee
AlphaMed Press / Stem Cells Translational Medicine
919-680-0011 230
Email Information

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Study shows cardiac stem cells outperform bone marrow stem cells in treating heart attacks

NEW YORK, Feb. 8, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or the "Company"), announced today that the Company and Progenitor Cell Therapy ("PCT"), a NeoStem company, will be presenting at two upcoming conferences in February.

Bio CEO & Investor Conference
Date: February 14, 2012, 9:30 AM
Venue: Waldorf Astoria Hotel, New York, New York
Presenter: Dr. Robin L. Smith, Chairman and CEO of NeoStem will provide a NeoStem corporate update.

New York Stem Cell Summit 2012
Date: February 21, 2012
Venue: Bridgewaters, New York, New York
Presenters: Dr. Robin L. Smith, Chairman and CEO of NeoStem will present NeoStem's corporate presentation at 1:47 PM and Robert A. Preti, PhD, President of PCT, will present on PCT's contract manufacturing services for the cell therapy industry at 11:41 AM

About NeoStem, Inc.

NeoStem, Inc. ("NeoStem") is a leader in the development and manufacture of cell therapies. NeoStem has a strategic combination of revenues, including that which is derived from the contract manufacturing services performed by Progenitor Cell Therapy, LLC, a NeoStem company. That manufacturing base is one of the few cGMP facilities available for contracting in the burgeoning cell therapy industry, and it is the combination of PCT's core expertise in manufacturing and NeoStem's extensive research capabilities that positions the company as a leader in cell therapy development. Amorcyte, LLC, also a NeoStem company, 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 has commenced enrollment in a Phase 2 trial for the preservation of heart function after a heart attack. Amorcyte expects to begin a Phase 1 clinical trial in 2012 for AMR-001 for the treatment of patients with congestive heart failure. Athelos Corporation, also a NeoStem company, is developing a T-cell therapy for a range of autoimmune conditions with its partner Becton-Dickinson. NeoStem's pre-clinical assets include its VSEL(TM) Technology platform for regenerative medicine, which NeoStem believes to be an endogenous, pluripotent, non-embryonic stem cell that has the potential to change the paradigm of cell therapy as we know it today.

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

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's successful development of cell therapeutics, as well as the future of the cell therapeutics industry. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's prospectus supplement filed with the Securities and Exchange Commission on September 30, 2011. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem Announces Participation in Two February Conferences

14-12-2011 20:22 Human tissue cells derived from induced pluripotent stem (iPS) cells recapitulate many of the characteristics and functionality expected of in vivo cell types. iCell® Cardiomyocytes are derived from human IPS cells and are currently being used in both drug discovery and basic research in Industrial and Academic settings. Dr. Eric Chiao of Hoffmann-La Roche Inc. (Roche) will lead this presentation and provide data showing the characterization and utility of iCell Cardiomyocytes, how they are being used in drug development, and how they are increasing our understanding of basic human cardiomyocyte cellular biology.

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Utilizing Stem Cell-derived Cardiomyocytes for Early Safety Screening - Webinar Presentation - Video

29-01-2012 23:26 Fourteen patients were randomized to see if adipose-derived adult stem cells would help limit the damage from an acute heart attack. Infarct size was decreased by 50%, the perfusion defect was 17% smaller, and the left ventriclular ejection fraction was increased about 6% better than the control group. Stem cell vocabulary was reviewed and highlighted that there are embryonic stem cells and adult stem cells and that sources of stem cell are from bone marrow, adipose tissue, blood, umbilical cord blood and from cloned embryonic cell lines. Stem cells can develop into 200 different cell types.

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Stem Cells Help Heart Attack Victims - Video

Posted: Monday, February 6, 2012 10:00 am | Updated: 11:50 am, Mon Feb 6, 2012.

Researchers at Rice University and Texas Children's Hospital have turned stem cells from amniotic fluid into cells that form blood vessels.

Their success offers hope that such stem cells may be used to grow tissue patches to repair infant hearts.

"We want to come up with technology to replace defective tissue with beating heart tissue made from stem cells sloughed off by the infant into the amniotic fluid," said Rice bioengineer Jeffrey Jacot, who led the study. "Our findings serve as proof of principle that stem cells from amniotic fluid have the potential to be used for such purposes."

The results were published online by the journal Tissue Engineering Part A. The research was conducted at Texas Children’s Hospital.

According to the American Heart Association, about 32,000 infants a year in the United States are born with congenital heart defects, 10,000 of which either result in death or require some sort of surgical intervention before they're a year old.

Jacot, an assistant professor of bioengineering based at Rice's BioScience Research Collaborative and of the Pediatric Cardiac Bioengineering Laboratory at the Congenital Heart Surgery Service at Texas Children’s Hospital, hopes to grow heart patches from the amniotic stem cells of a fetus diagnosed in the womb with a congenital heart defect. He said, because the cells would be a genetic match, there would be no risk of rejection.

"Between 60 and 80 percent of severe heart defects are caught by ultrasound," he said. "Ultimately, when a heart defect is diagnosed in utero, we will extract amniotic cells. By birth, we will have made tissue for the repair out of the infant's own cells. The timing is critical because the surgery needs to be done within weeks of the infant's birth."

Surgeons currently use such nonbiological materials as Dacron or Teflon, which do not contract or grow with the patient, or native pericardium, the membrane that surrounds the heart. Pericardium generally forms scar tissue and can only be used in the first operation. Both solutions require further operations and raise the risk of cardiac arrest, Jacot said.

Stem cells, the focus of both great hope and great controversy, are the cells in every organism that differentiate into specialized cells in the body. Stem cells drawn from human embryos are known to have great potential for treatment of defects and disease, but research into their use has been limited by political and other concerns, Jacot said.

That isn't the case with cells found in amniotic fluid, he said. Amniotic fluid is the liquid that protects and nourishes a fetus in the womb. Fluid is sometimes taken from pregnant women through amniocentesis, but cells for the Jacot lab's studies were drawn from women undergoing treatment for twin-twin transfusion syndrome.

"This is where two identical twins share a placenta and one is getting more blood than the other. It's not common," he said, noting that Texas Children's is one of the few hospitals that treat the syndrome. "Part of the general treatment is to remove fluid with the goal of saving both lives, and that fluid is usually discarded."

Jacot said other labs have tested amniotic fluid as a source of stem cells with promising results.

"Our work is based on five years of work from other labs in which they've discovered a very small population of amniotic stem cells – maybe one in every 10,000 – that naturally express markers characteristic of embryonic and mesenchymal stem cells."

Jacot and his team created a population of amniotic stem cells through a complex process that involved extracting cells via centrifugation and fluorescence-activated sorting. They sequestered cells with a surface receptor, c-kit, a marker associated with stem cells.

The cells were cultured in endothelial growth media to make them suitable for growing into a network of capillaries, Jacot said. When the cells were placed in a bio-scaffold, a framework used for tissue engineering, they did just that.

"Anything we make will need a blood supply," he said. "That's why the first cell type we looked for is one that can form blood vessels. We need to know we can get a capillary network throughout tissue that we can then connect to the infant's blood supply."

Jacot said the cells they tested grow very fast.

"We've done calculations to show that, with what we get from amniocentesis, we could more than grow an entire heart by birth," he said. "That would be really tough, but it gives us confidence that we will be able to quickly grow patches of tissue outside of the body that can then be sewn inside."

He said construction of a functional patch is some years away, but his lab is making progress. While embryonic cells have the most potential for such a project, amniotic cells already show signs of an ability to turn into heart muscle, he said.

Co-authors are graduate students Omar Benavides and Jennifer Petsche, both of Rice; and Kenneth Moise Jr. and Anthony Johnson, now professors at the Texas Center for Maternal and Fetal Treatment at The University of Texas Health Science Center at Houston with appointments at Children's Memorial Hermann Hospital.

The research was supported by the National Institutes of Health, the National Science Foundation Graduate Research Fellowship and CAREER programs, the Houston-Rice Alliance for Graduate Education and the Professoriate, the Howard Hughes Medical Institute Med into Grad Program and the Virginia and L.E. Simmons Family Foundation.

(Submitted by Rice University; Posted by Emiy Moser, emoser@hcnonline.com)

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Rice University, Texas Children’s Hospital researchers makes strides towards fixing infants hearts

Public release date: 6-Feb-2012
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Contact: Jeff Falk
jfalk@umn.edu
612-626-1720
University of Minnesota

A University of Minnesota-led research team has proposed a mechanism for the control of whether embryonic stem cells continue to proliferate and stay stem cells, or differentiate into adult cells like brain, liver or skin.

The work has implications in two areas. In cancer treatment, it is desirable to inhibit cell proliferation. But to grow adult stem cells for transplantation to victims of injury or disease, it would be desirable to sustain proliferation until a sufficient number of cells have been produced to make a usable organ or tissue.

The study gives researchers a handle on how those two competing processes might be controlled. It was performed at the university's Hormel Institute in Austin, Minn., using mouse stem cells. The researchers, led by Hormel Institute Executive Director Zigang Dong and Associate Director Ann M. Bode, have published a report in the journal Nature Structure and Molecular Biology.

"This is breakthrough research and provides the molecular basis for development of regenerative medicine," said Dong. "This research will aid in the development of the next generation of drugs that make repairs and regeneration within the body possible following damage by such factors as cancer, aging, heart disease, diabetes, or paralysis caused by traumatic injury."

The mechanism centers on a protein called Klf4, which is found in embryonic stem cells and whose activities include keeping those cells dividing and proliferating rather than differentiating. That is, Klf4 maintains the character of the stem cells; this process is called self-renewal. The researchers discovered that two enzymes, called ERK1 and ERK2, inactivate Klf; this allows the cells to begin differentiating into adult cells.

The two enzymes are part of a "bucket brigade" of signals that starts when a chemical messenger arrives from outside the embryonic stem cells. Chemical messages are passed to inside the cells, resulting in, among other things, the two enzymes swinging into action.

The researchers also discovered how the enzymes control Klf4. They attach a small molecule--phosphate, consisting of phosphorus and oxygen--to Klf4. This "tag" marks it for destruction by the cellular machinery that recycles proteins.

Further, they found that suppressing the activity of the two enzymes allows the stem cells to maintain their self-renewal and resist differentiation. Taken together, their findings paint a picture of the ERK1 and ERK2 enzymes as major players in deciding the future of embryonic stem cells--and potentially cancer cells, whose rapid growth mirrors the behavior of the stem cells.

Klf4 is one of several factors used to reprogram certain adult skin cells to become a form of stem cells called iPS (induced pluripotent stem) cells, which behave similarly to embryonic stem cells. Also, many studies have shown that Klf4 can either activate or repress the functioning of genes and, in certain contexts, act as either an oncogene (that promotes cancer) or a tumor suppressor. Given these and their own findings reported here, the Hormel Institute researchers suggest that the self-renewal program of cancer cells might resemble that of embryonic stem cells.

"Although the functions of Klf4 in cancer are controversial, several reports suggest Klf4 is involved in human cancer development," Bode said.

###

Established in 1942, the Hormel Institute is a world-renowned medical research center specializing in research leading to cancer prevention and control. It is a research unit of the University of Minnesota and a collaborative cancer research partner with Mayo Clinic.

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Hormel Institute study makes key finding in stem cell self-renewal

SACRAMENTO — A research team led by UC Davis Health System scientists has developed a novel technique to enhance bone growth by using a molecule which, when injected into the bloodstream, directs the body's stem cells to travel to the surface of bones. Once these cells are guided to the bone surface by this molecule, the stem cells differentiate into bone-forming cells and synthesize proteins to enhance bone growth. The study, which was published online today in Nature Medicine, used a mouse model of osteoporosis to demonstrate a unique treatment approach that increases bone density and prevents bone loss associated with aging and estrogen deficiency.

"There are many stem cells, even in elderly people, but they do not readily migrate to bone," said Wei Yao, the principal investigator and lead author of the study. "Finding a molecule that attaches to stem cells and guides them to the targets we need is a real breakthrough."

Researchers are exploring stem cells as possible treatments for a wide variety of conditions and injuries, ranging from peripheral artery disease and macular degeneration to blood disorders, skin wounds and diseased organs. Directing stem cells to travel and adhere to the surface of bone for bone formation has been among the elusive goals in regenerative medicine.

The researchers made use of a unique hybrid molecule, LLP2A-alendronate, developed by a research team led by Kit Lam, professor and chair of the UC Davis Department of Biochemistry and Molecular Medicine. The researchers' hybrid molecule consists of two parts: the LLP2A part that attaches to mesenchymal stem cells in the bone marrow, and a second part that consists of the bone-homing drug alendronate. After the hybrid molecule was injected into the bloodstream, it picked up mesenchymal stem cells in the bone marrow and directed those cells to the surfaces of bone, where the stem cells carried out their natural bone-formation and repair functions.

"Our study confirms that stem-cell-binding molecules can be exploited to direct stem cells to therapeutic sites inside an animal," said Lam, who also is an author of the article. "It represents a very important step in making this type of stem cell therapy a reality."

Twelve weeks after the hybrid molecule was injected into mice, bone mass in the femur (thigh bone) and vertebrae (in the spine) increased and bone strength improved compared to control mice who did not receive the hybrid molecule. Treated mice that were normally of an age when bone loss would occur also had improved bone formation, as did those that were models for menopause.

Alendronate, also known by the brand name Fosamax, is commonly taken by women with osteoporosis to reduce the risk of fracture. The research team incorporated alendronate into the hybrid molecules because once in the bloodstream, it goes directly to the bone surface, where it slows the rate of bone breakdown. According to Nancy Lane, a co-investigator on the study and director of the UC Davis Musculoskeletal Diseases of Aging Research Group, the dose of alendronate in the hybrid compound was low and unlikely to have inhibited the compound's therapeutic effect.

"For the first time, we may have potentially found a way to direct a person's own stem cells to the bone surface where they can regenerate bone," said Lane, who is an Endowed Professor of Medicine and Rheumatology and an expert on osteoporosis. "This technique could become a revolutionary new therapy for osteoporosis as well as for other conditions that require new bone formation."

Osteoporosis is a major public health problem for 44 million Americans. One in two women will suffer a fracture due to osteoporosis in their lifetime. Although effective medications are available to help prevent fracture risk, including alendronate, their use is limited by potential harmful effects of long-term use.

The major causes for osteoporosis in women include estrogen deficiency, aging and steroid excess from treatment of chronic inflammatory conditions such as rheumatoid arthritis. Generally, the osteoporosis generated by these metabolic conditions results from change in the bone remodeling cycle that weakens the bone's architecture and increases fracture risk.

Mesenchymal stem cells from bone marrow induce new bone remodeling, which thicken and strengthen bone.

The authors noted that the potential use of this stem cell therapy is not limited to treating osteoporosis. They said it may prove invaluable for other disorders and conditions that could benefit from enhanced bone rebuilding, such as bone fractures, bone infections or cancer treatments.

"These results are very promising for translating into human therapy," said Jan Nolta, professor of internal medicine, an author of the study and director of the UC Davis Institute for Regenerative Cures. "We have shown this potential therapy is effective in rodents, and our goal now is to move it into clinical trials."

Funding for the study came from the Endowment on Healthy Aging and the National Institutes of Health. The California Institute for Regenerative Medicine has given the team a planning grant to develop a proposal for human clinical trials.

"This research was a collaboration of stem cell biologists, biochemists, translational scientists, a bone biologist and clinicians," said Lane. "It was a truly fruitful team effort with remarkable results."

The Nature Medicine article is titled "Directing mesenchymal stem cells to bone to augment bone formation and increase bone mass." Min Guan, who is affiliated with the UC Davis Department of Internal Medicine, was co-lead author of the paper. Other UC Davis authors were Ruiwu Liu, Junjing Jia, Liping Meng, Ping Zhou and Mohammad Shahnazari, from the departments of Internal Medicine, and Biochemistry and Molecular Medicine, as well as the UC Davis Institute for Regenerative Cures. Authors Brian Panganiban and Robert O. Ritchie are with the Department of Materials Science and Engineering at UC Berkeley.

UC Davis is playing a leading role in regenerative medicine, with nearly 150 scientists working on a variety of stem cell-related research projects at campus locations in both Davis and Sacramento. The UC Davis Institute for Regenerative Cures, a facility supported by the California Institute for Regenerative Medicine (CIRM), opened in 2010 on the Sacramento campus. This $62 million facility is the university's hub for stem cell science. It includes Northern California's largest academic Good Manufacturing Practice laboratory, with state-of-the-art equipment and manufacturing rooms for cellular and gene therapies. UC Davis also has a Translational Human Embryonic Stem Cell Shared Research Facility in Davis and a collaborative partnership with the Institute for Pediatric Regenerative Medicine at Shriners Hospital for Children Northern California. All of the programs and facilities complement the university's Clinical and Translational Science Center, and focus on turning stem cells into cures. For more information, visit http://www.ucdmc.ucdavis.edu/stemcellresearch.

Read more:
Directing stem cells to boost bone formation, strength

The work has implications in two areas. In cancer treatment, it is desirable to inhibit cell proliferation. But to grow adult stem cells for transplantation to victims of injury or disease, it would be desirable to sustain proliferation until a sufficient number of cells have been produced to make a usable organ or tissue.

The study gives researchers a handle on how those two competing processes might be controlled. It was performed at the university's Hormel Institute in Austin, Minn., using mouse stem cells. The researchers, led by Hormel Institute Executive Director Zigang Dong and Associate Director Ann M. Bode, have published a report in the journal Nature Structure and Molecular Biology.

"This is breakthrough research and provides the molecular basis for development of regenerative medicine," said Dong. "This research will aid in the development of the next generation of drugs that make repairs and regeneration within the body possible following damage by such factors as cancer, aging, heart disease, diabetes, or paralysis caused by traumatic injury."

The mechanism centers on a protein called Klf4, which is found in embryonic stem cells and whose activities include keeping those cells dividing and proliferating rather than differentiating. That is, Klf4 maintains the character of the stem cells; this process is called self-renewal. The researchers discovered that two enzymes, called ERK1 and ERK2, inactivate Klf; this allows the cells to begin differentiating into adult cells.

The two enzymes are part of a "bucket brigade" of signals that starts when a chemical messenger arrives from outside the embryonic stem cells. Chemical messages are passed to inside the cells, resulting in, among other things, the two enzymes swinging into action.

The researchers also discovered how the enzymes control Klf4. They attach a small molecule--phosphate, consisting of phosphorus and oxygen--to Klf4. This "tag" marks it for destruction by the cellular machinery that recycles proteins.

Further, they found that suppressing the activity of the two enzymes allows the stem cells to maintain their self-renewal and resist differentiation. Taken together, their findings paint a picture of the ERK1 and ERK2 enzymes as major players in deciding the future of embryonic stem cells--and potentially cancer cells, whose rapid growth mirrors the behavior of the stem cells.

Klf4 is one of several factors used to reprogram certain adult skin cells to become a form of stem cells called iPS (induced pluripotent stem) cells, which behave similarly to embryonic stem cells. Also, many studies have shown that Klf4 can either activate or repress the functioning of genes and, in certain contexts, act as either an oncogene (that promotes cancer) or a tumor suppressor. Given these and their own findings reported here, the Hormel Institute researchers suggest that the self-renewal program of cancer cells might resemble that of embryonic stem cells.

"Although the functions of Klf4 in cancer are controversial, several reports suggest Klf4 is involved in human cancer development," Bode said.

Provided by University of Minnesota (news : web)

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New study makes key finding in stem cell self-renewal

NEW YORK--(BUSINESS WIRE)--

IntelliCell BioSciences, Inc. (OTCQB: SVFC.PK) (PINKSHEETS: SVFC.PK); (“IntelliCell”) or the (“Company”), was invited to demonstrate its stromal vascular fraction technology at the recent Baseball Injuries Symposium at the Andrews Sports Medicine Institute in Alabama held and sponsored by USA Baseball. The course Chairman is Dr. James Andrews, and moderated by PT Kevin Wilk, and Dr. Jeff Dugas. One of the courses presented during the three day event was on stem cell technology presented by Dr. Joshua Hackel. Dr. Hackel presented the state of regenerative medicine technology in the role of treating sports injuries. The link is http://www.mediafire.com/?u7bfa662e3r1sdp.

Dr. Hackel compared the IntelliCell SVF technology to several other methods of regenerative medicine being considered to be used by the leading orthopedic sports medicine doctors. Dr. Steven Victor, CEO of IntelliCell stated, "We are extremely excited that IntelliCell’s technology compares very favorably to all the other technologies, for procedures common to all major sports industries. We are extremely grateful to have the opportunity to present to over 200 leading doctors and trainers looking to treat major league, collegiate and amateur baseball players with regenerative medicine. IntelliCell Biosciences believes that its technology will be utilized by such experts this year."

About IntelliCell BioSciences, Inc.

IntelliCell is a pioneering regenerative medicine company focused on the expanding regenerative medical markets using stromal vascular fraction derived from adult adipose tissue. IntelliCell intends to initially focus on selling laboratory suites and licensing its technology to doctors for use in their offices for their patients. The company is also setting up Centers of Excellence where doctors can treat their patients. In addition, IntelliCell BioSciences is exploring storing the stromal vascular fraction in cryo-storage for future uses. The company is also starting FDA IND clinical trials at major medical centers for clinical indication approval. IntelliCell intends to pursue expansion to secondary markets and beyond the U.S. through a combination of company-owned and licensed clinical facilities.

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IntelliCell Demonstrates at the American Sports Medicine Institute Held in Conjunction with and at the Andrews Sports ...

07-11-2011 15:39 http://www.StemCellTreatment.org Salima had stem cell treatment for Fibromyalgia and had very good results. We have had great success with stem cell therapy for Fibromyalgia also known as FMS. Fibromyalgia symptoms include pain and tenderness in the joints, muscles and other soft tissue. Stem cell treatment for fibromyalgia is something that ASCAAC specializes in. Go to our website for more information and fill out the form or give us a call so we can answer your stem cell and fibromyalgia questions!

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Stem Cell Treatment Fibromyalgia - Video

20-12-2011 09:01 If you would like more information please call us Toll Free at 877-578-7908. Or visit our website at http://www.usastemcells.com Or click here to have a Free Phone Constultation with Dr. Matthew Burks usastemcells.com Real patient testimonials for USA Stem Cells. Adult stem cell therapy for COPD, Emphysema, and Pulmonary fibrosis.

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Adult Stem Cell Treatments for COPD -Real patient results, USA Stem Cells- Donald W. Testimonial - Video

10-01-2012 17:54 Cell-based therapy research at Swedish Heart and Vascular Institute is quintessential to medical advancement. Medical director Dr. Paul P. Huang researches stem cell therapy pertaining to cardiovascular disease. He provides an historical perspective of stem cell research and explains how stem cells can help cardiovascular patients avoid surgery and improve their quality of life. Dr. Huang believes that regenerative medicine is medicine's next frontier. For more information visit http://www.swedish.org

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Cell-based Therapy Research - Video

12-01-2012 07:24 If you would like more information please call us Toll Free at 877-578-7908. Or visit our website at http://www.usastemcells.com Or click here to have a Free Phone Constultation with Dr. Matthew Burks usastemcells.com Real patient testimonials for USA Stem Cells. Adult stem cell therapy for COPD, Emphysema, and Pulmonary fibrosis.

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Adult Stem Cell Treatments for COPD -Real patient results, USA Stem Cells- Leon B. Testimonial - Video

Public release date: 5-Feb-2012
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Contact: Charles Casey
charles.casey@ucdmc.ucdavis.edu
916-734-9048
University of California - Davis Health System

A research team led by UC Davis Health System scientists has developed a novel technique to enhance bone growth by using a molecule which, when injected into the bloodstream, directs the body's stem cells to travel to the surface of bones. Once these cells are guided to the bone surface by this molecule, the stem cells differentiate into bone-forming cells and synthesize proteins to enhance bone growth. The study, which was published online today in Nature Medicine, used a mouse model of osteoporosis to demonstrate a unique treatment approach that increases bone density and prevents bone loss associated with aging and estrogen deficiency.

"There are many stem cells, even in elderly people, but they do not readily migrate to bone," said Wei Yao, the principal investigator and lead author of the study. "Finding a molecule that attaches to stem cells and guides them to the targets we need is a real breakthrough."

Researchers are exploring stem cells as possible treatments for a wide variety of conditions and injuries, ranging from peripheral artery disease and macular degeneration to blood disorders, skin wounds and diseased organs. Directing stem cells to travel and adhere to the surface of bone for bone formation has been among the elusive goals in regenerative medicine.

The researchers made use of a unique hybrid molecule, LLP2A-alendronate, developed by a research team led by Kit Lam, professor and chair of the UC Davis Department of Biochemistry and Molecular Medicine. The researchers' hybrid molecule consists of two parts: the LLP2A part that attaches to mesenchymal stem cells in the bone marrow, and a second part that consists of the bone-homing drug alendronate. After the hybrid molecule was injected into the bloodstream, it picked up mesenchymal stem cells in the bone marrow and directed those cells to the surfaces of bone, where the stem cells carried out their natural bone-formation and repair functions.

"Our study confirms that stem-cell-binding molecules can be exploited to direct stem cells to therapeutic sites inside an animal," said Lam, who also is an author of the article. "It represents a very important step in making this type of stem cell therapy a reality."

Twelve weeks after the hybrid molecule was injected into mice, bone mass in the femur (thigh bone) and vertebrae (in the spine) increased and bone strength improved compared to control mice who did not receive the hybrid molecule. Treated mice that were normally of an age when bone loss would occur also had improved bone formation, as did those that were models for menopause.

Alendronate, also known by the brand name Fosamax, is commonly taken by women with osteoporosis to reduce the risk of fracture. The research team incorporated alendronate into the hybrid molecules because once in the bloodstream, it goes directly to the bone surface, where it slows the rate of bone breakdown. According to Nancy Lane, a co-investigator on the study and director of the UC Davis Musculoskeletal Diseases of Aging Research Group, the dose of alendronate in the hybrid compound was low and unlikely to have inhibited the compound's therapeutic effect.

"For the first time, we may have potentially found a way to direct a person's own stem cells to the bone surface where they can regenerate bone," said Lane, who is an Endowed Professor of Medicine and Rheumatology and an expert on osteoporosis. "This technique could become a revolutionary new therapy for osteoporosis as well as for other conditions that require new bone formation."

Osteoporosis is a major public health problem for 44 million Americans. One in two women will suffer a fracture due to osteoporosis in their lifetime. Although effective medications are available to help prevent fracture risk, including alendronate, their use is limited by potential harmful effects of long-term use.

The major causes for osteoporosis in women include estrogen deficiency, aging and steroid excess from treatment of chronic inflammatory conditions such as rheumatoid arthritis. Generally, the osteoporosis generated by these metabolic conditions results from change in the bone remodeling cycle that weakens the bone's architecture and increases fracture risk.

Mesenchymal stem cells from bone marrow induce new bone remodeling, which thicken and strengthen bone.

The authors noted that the potential use of this stem cell therapy is not limited to treating osteoporosis. They said it may prove invaluable for other disorders and conditions that could benefit from enhanced bone rebuilding, such as bone fractures, bone infections or cancer treatments.

"These results are very promising for translating into human therapy," said Jan Nolta, professor of internal medicine, an author of the study and director of the UC Davis Institute for Regenerative Cures. "We have shown this potential therapy is effective in rodents, and our goal now is to move it into clinical trials."

Funding for the study came from the Endowment on Healthy Aging and the National Institutes of Health. The California Institute for Regenerative Medicine has given the team a planning grant to develop a proposal for human clinical trials.

"This research was a collaboration of stem cell biologists, biochemists, translational scientists, a bone biologist and clinicians," said Lane. "It was a truly fruitful team effort with remarkable results."

###

The Nature Medicine article is titled "Directing mesenchymal stem cells to bone to augment bone formation and increase bone mass." Min Guan, who is affiliated with the UC Davis Department of Internal Medicine, was co-lead author of the paper. Other UC Davis authors were Ruiwu Liu, Junjing Jia, Liping Meng, Ping Zhou and Mohammad Shahnazari, from the departments of Internal Medicine, and Biochemistry and Molecular Medicine, as well as the UC Davis Institute for Regenerative Cures. Authors Brian Panganiban and Robert O. Ritchie are with the Department of Materials Science and Engineering at UC Berkeley.

UC Davis is playing a leading role in regenerative medicine, with nearly 150 scientists working on a variety of stem cell-related research projects at campus locations in both Davis and Sacramento. The UC Davis Institute for Regenerative Cures, a facility supported by the California Institute for Regenerative Medicine (CIRM), opened in 2010 on the Sacramento campus. This $62 million facility is the university's hub for stem cell science. It includes Northern California's largest academic Good Manufacturing Practice laboratory, with state-of-the-art equipment and manufacturing rooms for cellular and gene therapies. UC Davis also has a Translational Human Embryonic Stem Cell Shared Research Facility in Davis and a collaborative partnership with the Institute for Pediatric Regenerative Medicine at Shriners Hospital for Children Northern California. All of the programs and facilities complement the university's Clinical and Translational Science Center, and focus on turning stem cells into cures. For more information, visit http://www.ucdmc.ucdavis.edu/stemcellresearch.

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Researchers develop method of directing stem cells to increase bone formation and bone strength

RESEARCH TRIANGLE PARK, N.C., Feb. 6, 2012 /PRNewswire/ -- Chimerix, Inc., a biotechnology company developing novel antiviral therapeutics, today announced positive results from CMX001 Study 201, a Phase 2 study evaluating CMX001 for the prevention of cytomegalovirus (CMV) disease in hematopoietic stem cell transplant (HCT) recipients. CMX001 is a broad spectrum Lipid-Antiviral-Conjugate completing Phase 2 clinical development for the prevention of CMV in HCT recipients. In CMX001 Study 201, a double-blind, placebo-controlled trial which enrolled 230 HCT recipients, CMX001 had a statistically significant benefit versus placebo in preventing CMV viremia and/or CMV disease 13 weeks post-transplant.

Francisco Marty, MD, Assistant Professor of Medicine at Dana-Farber Cancer Institute and Brigham and Women's Hospital's Division of Infectious Disease, and a lead investigator in Chimerix's CMX001 Phase 2 CMV study, presented the data during the "Best Abstracts Plenary Session" at the 2012 BMT Tandem Meetings on February 3, 2012 in San Diego, California. "This study provides positive data supporting the antiviral activity of CMX001 at different dose levels, and a better understanding of CMX001's safety and tolerability as a prophylactic agent against CMV infection, a major cause of morbidity and mortality in bone marrow transplant recipients," said Dr. Marty.  "There is a substantial unmet medical need for safer and effective therapies against CMV. If approved, many patients have the potential to benefit from the future availability of CMX001."

"These results exceeded our high expectations, and we are thrilled to share such positive CMX001 data with the transplant community," said Wendy P. Painter, MD, MPH, Chimerix's Chief Medical Officer. "We look forward to initiating the Phase 3 CMV program later this year. This study reinforces our belief that CMX001's broad spectrum application against multiple viral infections, its safety profile and convenient oral dosing will enable it to become a new standard of care for transplant recipients." 

CMX001 Study 201 Results Presented at BMT Tandem Meetings

Results from subjects receiving CMX001 100 mg twice weekly met the primary endpoint, a statistically significant reduction in CMV viremia (CMV > 200 copies/mL) or disease at the end of treatment in CMX001-treated subjects versus those who received placebo (p=0.001). Moreover, CMX001 Study 201 showed that three different doses of CMX001 demonstrated statistically significant reductions in the proportion of subjects with CMV viremia ? 1000 copies/mL at any time during treatment when compared to placebo (p=0.002, <0.001, <0.001, respectively; see Table 1 below). In subjects who were CMV viremia negative prior to treatment, four different CMX001 dose regimens demonstrated statistically significant reduction versus placebo (see Table 2 below).

Table 1
Subjects with Clinically Relevant CMV Viremia
(> 1,000 copies/mL at any time during treatment)

Dose

Enrolled (N)

CMV Viremia (N)

%

P

40 mg QW(1)

25

10

40%

0.43

100 mg QW

27

6

22%

0.06

200 mg QW

39

7

18%

0.002

200 mg BIW(2)

30

2

7%

< 0.001

100 mg BIW

50

4

8%

< 0.001

Pooled Placebo

59

25

42%

-

(1)QW: Once weekly. (2)BIW: Twice weekly.

Table 2
Subjects with Clinically Relevant CMV Viremia – CMV Negative Strata
(> 1,000 copies/mL at any time during treatment)

Dose

Enrolled (N)

CMV Viremia (N)

%

P

40 mg QW

18

4

22%

0.55

100 mg QW

23

2

9%

0.04

200 mg QW

29

2

7%

0.02

200 mg BIW

22

0

0

0.002

100 mg BIW

41

0

0

< 0.001

Pooled Placebo

48

15

31%

-

There was no difference versus placebo across CMX001 treatment groups in measurements of renal function and hematologic parameters. Diarrhea was the most common adverse event seen in the CMX001 treatment groups and was dose-limiting at the highest dose of CMX001 (200 mg twice weekly).

CMX001 Study 201 Design

CMX001-201 was a randomized, double-blind, placebo-controlled, dose-escalation, multi-center trial evaluating the safety, tolerability, and ability of CMX001 to prevent or control CMV disease in 230 evaluable CMV seropositive allogeneic stem cell transplant recipients.  Following engraftment (Days 14-30 post-transplant), subjects were stratified based on the presence or absence of acute GVHD requiring systemic therapy and the presence or absence of CMV DNA in plasma and randomized (3:1, CMX001 versus placebo) into five sequential, dose-escalating cohorts. Subjects were treated once weekly or twice weekly for 9 to 11 weeks through post-transplant Week 13, after which subjects were followed for an additional 4 to 8 weeks. Placebo patient results were pooled for endpoint analysis.

About CMX001

CMX001 is a Lipid-Antiviral-Conjugate that delivers high intracellular levels of the active antiviral agent cidofovir-diphosphate and has broad spectrum in vitro activity against double-stranded DNA (dsDNA) viruses. CMX001 is completing Phase 2 clinical development for the prophylaxis of CMV and is in Phase 2 development for the preemption and treatment of adenovirus infection in HCT recipients. Antiviral activity results from completed and ongoing studies, coupled with the lack of myelotoxicity and nephrotoxicity seen in currently available therapies, indicate that CMX001 has the potential to improve outcome for immunosuppressed patients.

To date, more than 700 patients have been dosed with CMX001 in placebo-controlled clinical trials and open-label treatment protocols. As part of Chimerix's open-label treatment protocols, data were recently presented at ICAAC 2011[1] in an oral presentation entitled "CMX001 is not nephrotoxic or myelosuppressive in 183 patients with life threatening dsDNA infections including refractory Cytomegalovirus, Adenovirus, and BK Virus".

About Cytomegalovirus

CMV is a member of the herpesvirus group of dsDNA viruses. Like other herpesviruses, CMV has the ability to remain dormant in the body for long periods of time. In immunocompromised individuals, including transplant recipients, cancer patients and children born with primary CMV infection, CMV can lead to serious disease or death. At least 65% of transplant recipients are at moderate-to-high risk of CMV due to reactivation of latent virus from donor or recipient tissues. In these patients, CMV disease can lead to severe and potentially life-threatening conditions such as nephritis, pneumonitis or hepatitis, or complications such as acute or chronic rejection of a transplanted organ. While currently available systemic anti-CMV agents can be effective against the virus, their use is limited by significant toxicities, including myelotoxicity and nephrotoxicity.

About Chimerix

Chimerix is developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health. Utilizing proprietary lipid conjugate technology, the company's two clinical stage compounds have demonstrated the potential for enhanced activity, bioavailability and safety compared to currently approved drugs. 

In addition to the company's development of its lead candidate, CMX001, for transplant recipients, CMX001 is also being developed as a medical countermeasure in the event of a smallpox release, with the potential to provide an important therapeutic option for the 80 million people in the U.S. currently estimated to be immunocompromised, or a household contact of a contraindicated individual, and thus not candidates to receive a smallpox vaccine (for additional information, please see http://www.bt.cdc.gov/agent/smallpox/vaccination/contraindications-clinic.asp). Chimerix has received federal funding for the development of CMX001 as a medical countermeasure against smallpox from the National Institute of Allergy and Infectious Diseases under Grant No. U01-A1057233 and from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201100013C. 

Chimerix's second clinical-stage antiviral compound, CMX157, is a Lipid-Antiviral-Conjugate that delivers high intracellular levels of the active antiviral agent tenofovir-diphosphate. CMX157 is in development as a potent nucleoside analogue against HIV and HBV infections, and has the potential to directly address several limitations of current therapies. CMX157 has completed a Phase 1 clinical trial in healthy volunteers, providing pharmacokinetic data which support the compound's enhanced characteristics. 

Led by an experienced antiviral drug development team, Chimerix is also leveraging its lipid conjugate technology and extensive chemical library to pursue new treatments for hepatitis C virus, influenza, and other areas of high unmet medical need. For additional information on Chimerix, please visit http://www.chimerix.com.&nbsp;

[1] Genovefa Papanicolau, MD, Associate Member of Infectious Diseases Service at Memorial Sloan-Kettering Cancer Center, at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Annual Meeting, 2011.

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Chimerix Antiviral Compound, CMX001, Meets CMV Phase 2 Primary Endpoint in Allogeneic Hematopoietic Stem Cell ...

Boris family gift propels stem cell therapies and one-stop patient care

Newswise — HAMILTON, ON (Feb. 6, 2012) – A Hamilton family is giving McMaster University $30 million to accelerate the university’s innovations in health research, education and care.

“McMaster University has proven its ability to fast forward discoveries from the lab bench to the patients’ bedside, it made perfect sense to make this investment in this world class university,” said Les Boris, on behalf of his parents’ Marta and Owen Boris Foundation. His sister Jackie Work added: “The Michael G. DeGroote School of Medicine is ranked among the top 20 medical schools in the world. This is the best place to commit to the future.”

The funding was announced in a ceremony at the University today.

Of the total, $24 million is designated to establish The Boris Family Centre in Human Stem Cell Therapies, which will speed the commercial development of discoveries at the McMaster Stem Cell and Cancer Research Institute. The six-year-old institute has had several major breakthroughs, including the ability to turn human skin into blood.

The funds will establish two senior research chairs, one in blood stem cells and the other in neuro stem cells; set up several fellowships and technician positions;
build the facility and provide a fund for emerging opportunities.

An additional $6 million is for a unique clinic which will allow patients with complex health problems to see several specialists and have related tests during one visit. Established in partnership with Hamilton Health Sciences, this patient-oriented clinic will be built in the McMaster University Medical Centre in Hamilton and led by a senior research chair.

The Marta and Owen Boris Foundation was established by Marta and Owen Boris who created the Hamilton cable company Mountain Cablevision and developed it over 50 years before selling it to Shaw Communications in 2009.

Owen Boris died in April, 2011.

“McMaster has been renewing its commitment to our community, and to have community members make such a significant contribution to the University is truly outstanding,” said Patrick Deane, president of McMaster. “Great research, great discoveries, and better patient care. The Boris family gift will accelerate nour ability to make great things happen.”

Dr. John Kelton, dean and vice-president of the Faculty of Health Sciences, added: “This is an innovative and action oriented family. They understand the great potential McMaster has to make medical breakthroughs, and their willingness to place their bets on McMaster is a tremendous vote of confidence in us.”

Mick Bhatia is scientific director of the McMaster Stem Cell and Cancer Research Institute. He said: “In a short time we’ve become world renowned for our human stem cell discoveries. Now is the time to move these discoveries to the patient.”

About the clinic for day patients, Dr. Akbar Panju, professor and deputy chair clinical of the Department of Medicine, said the new format is unique in Canada and will put patients first.

“Too often patients go from office to office to receive essential medical care from several specialists. This clinic will ensure they will get everything they need in one place,” he said, noting that the clinic will also be a centre of learning for
health sciences students and residents from many disciplines.

McMaster University, one of four Canadian universities listed among the Top 100 universities in the world, is renowned for its innovation in both learning and discovery. It has a student population of 23,000, and more than 150,000 alumni in 128 countries.

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$30m Gift to Fast Forward Stem Cell Therapies and One-Stop Patient Care

Q. What are human stem cells?

A. Stem cells are the blank slates of the body that are used as the building blocks for growth, repair and replacement. As blank slates, these cells can be triggered to develop into the specific types of cells that make up tissues.

There are two different kinds of stem cells, based on their development potential. One category is known as pluripotent stem cells, meaning they have the ability to develop into any type of tissue in the body. Pluripotent stem cells can be broken into two subcategories: those that are derived from human embryos, and those that are created from human skin cells, based on pioneering research conducted at McMaster University.

The second category are adult, or somatic, stem cells, which are found in the various organs and tissues of the body. These, too, are blank slates that can be triggered to differentiate, but they can only be transformed into the cell types that are specific to that particular tissue.

“When you talk about adult stem cells, they come in different flavours and they’re very specific in their role but they don’t have the broad potential that pluripotent stem cells have,” said Dr. Mick Bhatia, director of the McMaster Stem Cell and Cancer Research Institute.

Q. Why are they considered important in medical research?

A. Somatic stem cells are important because not only can they be triggered to develop into specific cell types, they can also make copies of themselves, so there’s always a reservoir. Maintaining a fine-tuned balance is critical. “It’s analogous to an accelerator and a brake,” said Bhatia. “They have to know when to accelerate to produce new cells … and you have to know when to stop. So what are those signals and how they are orchestrated is part and parcel of understanding stem cells.” Understanding how stem cells work could help researchers better understand certain disease conditions, such as cancer.

But it’s also possible that stem cells can be used as treatments, to repair or replace damaged tissues. The trick is to trigger them to differentiate into the proper types of cells in the right places and getting them to work in harmony with the rest of the team. One advantage is that the body’s own cells are being used, so they won’t be rejected as foreign objects by the immune system.

Q. What types of conditions could potentially benefit from stem cell interventions?

A. Diabetes (replacement of insulin-producing cells in the pancreas), Parkinson’s disease, Alzheimer’s disease, spinal cord trauma, leukemia, strokes (replacement of damaged brain tissue) and other forms of cardiovascular disease.

“By understanding the stem cells, we at least have some potential to deal with these diseases,” said Bhatia. “Right now, we’re simply managing chronic disease. There are no cures.

“I think the hope with stem cells is really to fix or cure things.”

Q. Why has the issue of embryonic stem cells raised controversy, particularly in the U.S.?

A. Embryonic stem cells are derived from human embryos created through in vitro fertilization. However, the creation of a line of embryonic stem cells requires the destruction of the embryo. For religious, cultural or even philosophical reasons, some people believe human life begins when an egg is fertilized, so they believe the destruction of an embryo is equal to the destruction of a human life.

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Stem cell Q and A

Forbes

NPR's Bias Against Genetic Engineering Forbes While its programs cover global warming and the environment from every angle, embracing the most recent apocalyptic predictions, they permit continual attacks on genetic engineering applied to agriculture. This technology – an extension, or refinement, ... and more »

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http://news.google.com/news?q=genetic-engineering&output=rss