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Diverse approach to cancer research need of the hour, stresses professor

Posted: February 28, 2012 at 10:42 pm

Diverse approach to cancer research need of the hour, stresses professor Profoundly different approaches are needed for cancer research, the Qatar International Conference on Stem Cell Science and Policy 2012, has been told by an expert in cancer stem cell (CSC) biology.
Professor Irving Weissman, director, Stanford Institute for Stem Cell Biology and Regenerative Medicine, Stanford University, was delivering a keynote address on ‘Normal and neoplastic stem cells’ yesterday.
“Self-renewal is the principal property that distinguishes stem cells from their daughter cells,” he said while explaining that when stem cells divide they give rise to stem cells (by self-renewal) and progenitors (by differentiation).
The balance between self-renewal and differentiation is what generates, and then maintains, tissues enabling them to respond to injury or other stressors.
Studies identifying hematopoietic stem cells (HSC) - which form blood and immune cells - and progenitors, have made hematopoiesis one of the best systems for studying the molecular changes in cell fate decision-making and creation of cancer.
Further, it serves as a paradigm for finding preclinical and clinical platforms for tissue and organ replacement and regeneration.
Stem cell isolation and transplantation is the basis for regenerative medicine. Self-renewal is dangerous and therefore strictly regulated.
Poorly regulated self-renewal can lead to the genesis of CSC — the only cells within a tumour or leukaemia that have the ability to self renew, and therefore the cells that maintain the cancer.
“Thus, it is predicted that CSC elimination is required for cure. This prediction necessitates profoundly different approaches to cancer research, compelling investigators to prospectively isolate CSCs and to characterise the molecular pathways regulating their behaviour in order to identify targeted and truly effective therapies,” Weissman added.
A founder of three companies – SyStemix, Cellerant, and Stem Cells Inc – all focused on bringing stem cell therapies into the clinic, Weissman has authored more than 700 scientific articles and has been an editor of multiple scientific journals.

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Experts discuss stem cell banking ethics, policies

Posted: February 28, 2012 at 10:42 pm

Experts discuss stem cell banking ethics, policies By Noimot Olayiwola
Staff Reporter
Umbilical cord blood banking and transplantation, issues of ethics and policy as well as regulations governing stem cell banking were some of the high points of discussion during a session on ‘Stem Cell Banking’ at the Qatar International Conference on Stem Cells Science and Policy, underway at the Qatar National Convention Centre.
Sharing the Saudi Arabia experience on umbilical cord blood transplantation during a presentation, King Faisal Specialist Hospital and Research Centre’s blood bank (transfusion & donor services) director and of the Stem Cell Cord Blood Bank at the department of pathology and laboratory medicine, Dr Hind al-Humaidan, noted that the transplantation of allogeneic (taken from different individuals of the same species) bone marrow has been successfully used in the treatment of high risk or recurrent hematologic malignancies, bone marrow failure syndromes, selected hereditary immunodeficiency states and metabolic disorders.
“Early in the history of bone marrow transplantation, it was clear that access to a suitable donor was a major obstacle severely limiting the use of this potentially curative treatment modality. Although using an HLA (human leukocyte antigen) sibling donor is the best choice for transplantation, not all patients could have access to such a donor. Therefore transplant centres explored the possibility of using volunteer adult unrelated donors as an alternative to HLA–matched siblings,” she noted while mentioning that there was another alternative treatment strategy as a source of hematopoietic stem cell namely umbilical cord blood.
She explained that in Saudi Arabia, 60% of patients who need a transplant will find an HLA-matched sibling donor, leaving 40% of the patients in need of alternative sources.
The figure of donor with HLA-matched sibling elsewhere in the world is 45%, she said.
“The concept of establishing a cord blood bank in Saudi Arabia, under the umbrella of King Faisal Specialist Hospital and Research Centre, was raised after an increase in use of cord blood for transplantation due to the inability of finding fully or closely HLA-matched related donors. This non-profit public Cord Blood Bank is dedicated to making high quality cord blood units available to all patients in need of related and/or unrelated transplantation in Saudi Arabia and in the neighbouring countries through the development and maintenance of a centre of excellence for the collection, storage, search and distribution of ethnically and racially diverse cord blood units,” she said.
According to al-Humaidan, till date, the Cord Blood inventory consists of 3,725 units of high quality cord blood with a total of 70 cord blood transplants being carried out from the inventory.
Virgin Health Bank (VHB) chief executive officer Dr Rajan Jethwa discussed ways to make a cord blood bank attractive to users and how to ensure sustenance, especially when government funding of such facilities stops.
He described how VHB will become the magnet that will pull all stakeholders in the field of stem cell banking including researchers, technicians together towards achieving the establishment of a stem cell bank in Qatar.
Wake Forest School of Medicine’s Internal Medicine and Institute for Regenative Medicine Social Sciences and Health Policy professor Nancy King highlighted some of the ethical and policy issues governing stem cell banking globally while Field Fisher Waterhouse’s Public and Regulatory Law Group head Sarah Ellson shared some tips on ensuring regulations of biosamples. University of Central Lancashire’s Dr Katrina Aisha Choog spoke on informed consent among Arab Muslim research participants. The session was chaired by Harvard Stem Cell Institute’s executive director Brock Reeve.

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Stem Cell Pioneers Converge in Portland to Discuss and Celebrate a Revolutionary New Stem Cell Entering Human Clinical …

Posted: February 28, 2012 at 10:42 pm

SAN DIEGO, CA and PORTLAND, OR--(Marketwire -02/28/12)- Medistem Inc. (Pinksheets: MEDS.PK - News) announced today its Annual "Evening with Medistem" Event will take place in Portland, Oregon on March 7th, 2012. The event is being hosted by Vladimir Zaharchook, Vice Chairman at Medistem, Inc., and will feature stem cell luminaries and pioneers working with Medistem including Dr. Amit Patel, Director of Regenerative Medicine at University of Utah and the first person to administer stem cells into patients with heart failure, Dr. Michael Murphy, Vascular Surgeon at Indiana University and Principal Investigator for Medistem's FDA clinical trial in patients with risk of amputation, and Dr. Alan Lewis, former CEO of the Juvenile Diabetes Research Foundation, advisory board member of Medistem.

In 2007 Medistem discovered an entirely new type of stem cell, the Endometrial Regenerative Cell (ERC). This cell has proven it is a "universal donor" and can be used to treat many more conditions compared to other types of stem cells. The company received FDA clearance to begin clinical trials in September of 2011 for critical limb ischemia, a condition that is associated with amputation. Medistem is also running a Phase II clinical trial for heart failure using the new stem cell. The ERC stem cell does not involve the highly controversial use of fetal tissue, can be produced very economically and administered to the patient in a very simple manner. Medistem is exploring ways to expand clinical trials of its stem cell into other diseases.

"Stem cells and regenerative medicine offer hope in clinical conditions in which hope previously did not exist," said Dr. Stanley Cohan, Head of Neurology at the St Vincent's Hospital, the largest center for treatment of multiple sclerosis in the Pacific Northwest, who will be attending the event. "We are honored in the Portland community to have this distinguished team of accomplished researchers and medical doctors convene here and discuss with us possible collaborations."

"As a long-time member of the Portland academic community, it is exciting to have companies such as Medistem to visit us and share their experiences 'from the trenches' of what it takes to push a cellular drug through the FDA," said Dr. Shoukrat Milipotiv, Associate Scientist in the Division of Reproductive & Developmental Sciences of ONPRC, Oregon Stem Cell Center and Departments of Obstetrics & Gynecology and Molecular & Medical Genetics, and co-director of the ART/ESC core at the Center. He is an internationally recognized researcher in the area of stem cells.

"The Event is an annual celebration to honor our team and collaborators for the successes of the previous year, while at the same time educate the local business and medical community on the latest research on stem cells not just at Medistem but internationally," said Thomas Ichim, Ph.D Chief Executive Officer of Medistem Inc. "2012 is particularly exciting for us due to approvals for two clinical trials, and the initiation of patient treatments within this context."

About Medistem Inc.

Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure.

Cautionary Statement

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

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Ovarian Stem Cells Make Human Eggs in Possible Aid to Fertility

Posted: February 28, 2012 at 5:36 pm

February 28, 2012, 11:02 AM EST

By Ryan Flinn

Feb. 27 (Bloomberg) -- Stem cells taken from human ovaries were used to produce early-stage eggs by scientists in Boston who may have created a new method to help infertile women.

Females have a fixed number of eggs from birth that are depleted by the time of menopause. The finding, published today in the journal Nature Medicine, challenges the belief that their ovaries can’t make more. The research was led by Jonathan Tilly, the director of Massachusetts General Hospital’s Vincent Center for Reproductive Biology.

Tilly reported in 2004 that ovarian stem cells in mice create new eggs, or oocytes, in a way similar to how stem cells in male testes produce sperm throughout a man’s life. His latest work, if reproduced, would suggest the same is true for human ovaries, potentially pointing at new ways to aid fertility by delaying when the ovaries stop functioning.

“The 50-year-old belief in our field wasn’t actually based on data proving it was impossible, or not ongoing,” Tilly said in a telephone interview. “It was simply an assumption made because there was no evidence indicating otherwise. We have human cells that can produce new oocytes.”

In the study, healthy ovaries were obtained from consenting patients undergoing sex reassignment surgery. The researchers were able to identify ovarian stem cells because they express a rare protein that’s only seen in reproductive cells.

The stem cells from the ovaries were injected into human ovarian tissue that was then grafted under the skin of mice, which provided the blood supply that enabled growth. Within two weeks, early stage human follicles with oocytes had formed.

7-Million Eggs

A female is most endowed with oocytes, or eggs, as a fetus, when she has about 7 million. That number that drops to 1 million by birth, and around 300,000 by puberty. By menopause, the number is zero. Since the 1950’s, scientists thought that ovarian stem cells capable of producing new eggs are only active during fetal development.

“This paper essentially opens the door to the ability to control oocyte development in human ovaries,” Tilly said.

About 10 percent of women of child-bearing age in the U.S., or 6.1 million, have difficulty getting pregnant or staying pregnant, according to the Centers for Disease Control and Prevention. Most cases of female infertility are caused by problems with ovulation, hormone imbalance or age.

The study by Tilley and his colleagues offers “a new model system for understanding the human egg cell,” said David F. Albertini, director of the Center for Reproductive Services and professor in the department of molecular and integrative physiology at Kansas University, in a telephone interview.

‘Practical Applications”

Still, “there’s a long way to go before this has real practical applications. I’ve spent 35 years of my life studying egg cells and this is a cell that is at least as complicated as a neuron in the brain, if not more,” Albertini said.

The work needs to be reproduced and expanded by other scientists “to make it into something that will make us confident the cells are safe to use and we could actually use them to repopulate an egg-depleted ovary,” he said.

Tilly’s team is exploring the development of an ovarian stem-cell bank that can be cryogenically frozen and thawed without damage, unlike human eggs, he said. The researchers are also working to identify hormones and other growth factors for accelerating production of eggs from human ovarian stem cells and ways to improve in-vitro fertilization.

“The problem we face with IVF is we don’t have many eggs to work with,” he said. “These cells are renewable. If we are successful -- and it’s a big if -- in generating functioning eggs from these cells, we can generate as many eggs as we need to on a per patient basis.”

Tilly is also collaborating with researchers at the University of Edinburgh in the U.K. to determine whether the oocytes can be developed into fully mature human eggs for fertilizing. The U.S bans creating or fertilizing embryos for experimental purposes, he said.

A company Tilly co-founded, Boston-based OvaScience Inc., has licensed the technology for potential commercial applications.

--With assistance from Sarah Frier in New York. Editors: Angela Zimm, Andrew Pollack

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Nitkowski hoping stem cells lead to comeback

Posted: February 28, 2012 at 5:36 pm

Left-hander C.J. Nitkowski appeared in 336 games, mostly in a relief role, over parts of 10 seasons. (AP)

The last known whereabouts of C.J. Nitkowski, in regard to his Major League career, was Washington, some seven years ago. It's entirely possible -- maybe even probable -- that this career is 100 percent over and out.

Yet there was Nitkowski on a field in the Dominican Republic last month, working in setup situations for Gigantes del Cibao in the middle of the Dominican Winter League's round-robin playoffs. Hoping, perhaps against hope, that some scout would take note of his new sidearm delivery and effectiveness against lefties and upper-80s gun readings and determine that he's worth another look. Hoping, basically, for one more chance -- a chance, he believes, that would have been completely out of the question if not for the blood-and-stem-cell treatments he received last summer. "From a medical standpoint," Nitkowski says, "[the treatments have] been a success. I'm healthy." But the route he took to get to this point is, in many ways, misunderstood. Nitkowski, who will turn 39 next week, received treatment identical to the one that picked Bartolo Colon's ailing arm and career off the scrap heap and made him a prominent member of the Yankees rotation last season. It's a treatment that, in Colon's case, caused a bit of an uproar in the headlines last summer, as such labels as "disputed" and "controversial" were used to describe it. In reality, though, the use of one's own stem cells to promote healing in an injured area is far from a new development. In fact, the microfracture procedure that is becoming more and more common in the treatment of knee injuries (it was performed on Victor Martinez last month) is, at its core, a stem-cell procedure. In microfracture, tiny holes are drilled in the bone to allow marrow to drip out and repair damaged tissue -- the mesenchymal stem cells inside the marrow provide the repairing power. In the cases of Nitkowski and Colon, the mesenchymal stem cells were extracted from bone marrow and from body fat and then injected into a blood-poor area -- Nitkowski's left shoulder and Colon's right shoulder and elbow -- to promote healing. Now, is this really a reliable way to treat an ailing athlete? That's a subject of scrutiny. Embryonic stem cells are the cause of controversy all their own, given the ethical and political debates over their use and concern by some members of the medical community that they have the potential to become cancerous tumors. With mesenchymal stem cells, on the other hand, the debate is not over morals or safety but, rather, efficacy. "There's very little evidence that bone marrow stem cells taken from one site and injected into another will do anything," Theodore Friedmann, a geneticist at the University of California at San Diego who heads the World Anti-Doping Agency's (WADA) gene doping panel, told ESPN The Magazine recently. "The most likely outcome is that if you put stem cells in places that are unfamiliar to them, like a knee or shoulder, most of them will just die." WADA initially banned all blood-spinning therapies before reversing its position in 2011 after studies failed to demonstrate that they enhance performance the way steroids do. So WADA currently has no position on the use of stem-cell treatments. In the face of skepticism, you have the case of Colon, who in the spring of 2010 was unsigned, unable to get any of his old velocity on his fastball and seemingly at the end of a once-dazzling career. Dr. James Purita, founder of the Institute of Regenerative and Molecular Orthopedics in Boca Raton, Fla., traveled to the Dominican Republic to perform platelet-rich plasma (PRP) and stem-cell treatments to help repair ligament damage in Colon's elbow and aid a torn rotator cuff. "There was a stigma that it was illegal, because we did it in the Dominican," Purita said. "But it was just because he lived there." And there was another stigma. Because Colon not only returned to the Majors but thrived in the first half of the 2011 season, some wondered if the procedure could be labeled a performance-enhancer. When Colon's story became public, Purita was questioned by Major League Baseball officials to ensure that he did not use human growth hormone in the procedure. Purita has admitted using HGH when treating non-athletes but said he knows better than to do so in these cases. MLB did a complete investigation, and no further action was taken. "We're not reinventing the wheel here," Purita said. "We've done a number of these procedures on people from all the major sports, with the exception of hockey. We've done some of the top players. But we keep it very discreet." The reason for the discretion, beyond the obvious HIPAA standards, is that some teams are leery of or reluctant to trust these stem-cell treatments. Purita said that he performed the procedure this winter on a Major League free agent who expressed an explicit desire that word not get out, because he didn't want it to affect his contract negotiations. However, the case of Colon, who signed a one-year, $2 million contract with the A's this winter, makes one wonder if biologic stem cells could be the next medical revolution, following arthroscopy and the ulnar collateral ligament replacement known as Tommy John surgery. Nitkowski, for one, hopes to find out. A member of eight Major League teams over parts of 10 seasons from 1995-2005, the left-handed Nitkowski appeared in 336 games, mostly in a relief role. In 2006 he began a five-year stint pitching for various teams in Asia -- first in the Japanese Pacific League, then in the Korean Baseball Organization. A year ago, hoping for another shot in the bigs, he began working on a sidearm delivery, only to injure his shoulder. It was around that time that Nitkowski heard about Colon. Intrigued, he made a call to Purita's office, and, within weeks he was in Boca Raton to undergo the procedure himself. Purita first drew fat from Nitkowski's waist, then drew bone marrow from the left side of Nitkowski's lower back. The liquids were spun in a centrifuge at 2,000 rotations per minute for about 15 minutes, isolating the platelets. They were then inserted into syringes and placed under an LED light for about 20 minutes -- a process that supposedly "kick starts" the cells inside. Once this process was complete, Purita injected the platelet-rich plasma and stem cells into Nitkowski's labrum and rotator cuff. This is an important distinction. Under U.S. Food and Drug Administration guidelines, mesenchymal stem cells must be "minimally manipulated," meaning they can't be harvested in a lab for days or weeks or transported elsewhere. "Everything," Purita said, "has to be used the same day, on the same patient, and everything has to be done at the point of care." In Nitkowski's case, the whole process took about four hours. Much to his amazement, he had full range of motion within 24 hours. "The rehab starts right away," he said. "You have to commit to it, like any injury. I never thought I had the mindset to do the tedious rehab work. But if you want it bad enough, you'll do it." Nitkowski's stem-cell treatment was performed in July of last year. And per the usual protocol in Purita's treatment plan, Nitkowski had a second PRP treatment four weeks later. By November he was throwing off a mound, and he was pleased with how his arm felt and how his sidearm-delivered stuff worked in the Dominican Republic last month. "I was sitting at 86, 87 [mph] and hitting 88-89," he said. "That's more than enough [velocity] from that arm angle." Though he hasn't pitched in the bigs in seven years, Nitkowski believes he could help a team, and he's hoping someone will give him a tryout in Spring Training.

Anthony Castrovince is a reporter for MLB.com. Read his columns and his blog, CastroTurf, and follow him on Twitter at @Castrovince. This story was not subject to the approval of Major League Baseball or its clubs.

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Bioheart Announces University of Miami as Clinical Site for ANGEL Trial of LipiCell(TM)

Posted: February 28, 2012 at 5:34 pm

SUNRISE, Fla., Feb. 28, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced that the company will conduct the ANGEL trial using adipose (fat) derived stem cell technology or LipiCell(TM) at the University of Miami Miller School of Medicine. Bioheart recently applied to the FDA to begin trials using adipose derived stem cells in patients with chronic ischemic cardiomyopathy.

"Dr. Joshua Hare and the University of Miami are world leaders in the field of stem cell research," said Mike Tomas, President and CEO of Bioheart. "We look forward to working with these acclaimed experts and bringing the LipiCell(TM) technology to patients in the U.S."

The clinical protocol of the ANGEL trial is designed to assess the safety and cardiovascular effects of intramyocardial implantation of autologous adipose derived stem cells (LipiCell(TM)) in patients with chronic ischemic cardiomyopathy. Joshua Hare, MD, Director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine is the principle investigator of the clinical program.

The Interdisciplinary Stem Cell Institute was established to capitalize on pioneering work in the use of adult stem cells for the repair of malfunctioning human organs. The goal of the Institute is to find new treatments for heart disease, neurological disease, bone disease, diabetes, cancer, eye diseases and other chronic, debilitating, or incurable diseases. University of Miami scientists have led in the development of procedures to extract adult stem cells and have conducted ground breaking research in cell-based therapy for the diseased human heart.

About Bioheart, Inc.

Bioheart is committed to maintaining our 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. Our goals are to cause damaged tissue to be regenerated, if possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, we are 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. Our 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.

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, 2010, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011.

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Baxter Initiates Phase III Adult Stem Cell Clinical Trial for Chronic Cardiac Condition

Posted: February 28, 2012 at 5:34 pm

DEERFIELD, Ill.--(BUSINESS WIRE)--

Baxter International Inc. (NYSE:BAX - News) announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual’s own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).

Chronic myocardial ischemia (CMI) is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions.

“The prospect of using a person’s own adult stem cells to restore and repair blood flow in CMI is a very exciting concept based on a biological regenerative approach,” said Norbert Riedel, Ph.D., Baxter’s chief science and innovation officer. “The goals of this phase III trial are aligned with Baxter’s overall mission to develop life-saving and life-sustaining therapies and it will help us determine if the therapy can make a meaningful difference for CMI patients.”

The trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms: treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care. The primary objective is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with CMI, as measured by a change in total exercise capacity at 12 months following treatment. Secondary objectives include reduced frequency of angina episodes at 12 months after treatment and the safety of targeted delivery of the cells.

After stem cell mobilization, apheresis (collecting the cells from the body) and cell processing, participants will receive CD34+ stem cells or placebo in a single treatment via 10 intramyocardial injections into targeted areas of the heart tissue. Efficacy will be measured by a change in total exercise capacity during the first year following treatment and safety data will be collected for two years. Stem cell processing will be conducted in GMP facilities in the United States by Progenitor Cell Therapy (PCT), a subsidiary of NeoStem, Inc. To learn more or enroll, visit http://www.renewstudy.com or http://www.clinicaltrials.gov.

This trial is being initiated based on the phase II data, which indicated that injections of patients’ own CD34+ stem cells may improve exercise capacity and reduce reports of angina episodes in patients with chronic, severe refractory angina.

“The phase II trial provided evidence that this strategy, leveraging the body’s own natural repair mechanisms, can improve exercise capacity and reduce chest pain, the first time these endpoints have been achieved in a population of patients who have exhausted conventional treatment options,” said Douglas Losordo, MD, vice president of new therapeutic development at Baxter.

CD34+ cells, which are blood-forming stem cells derived from bone marrow, are comprised of endothelial progenitor cells (EPCs), which develop into new blood vessels. Previous preclinical studies investigating these cells have shown an increase in capillary density and improved cardiac function in models of myocardial ischemia.

About Baxter

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the use of adult autologous stem cells to treat CMI, including expectations with respect to the related phase III clinical trial. These statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: clinical results demonstrating the safety and effectiveness of the use of autologous stem cells to treat CMI; timely submission of regulatory filings; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; the enrollment of a sufficient number of qualified participants in the phase III clinical trial; the successful provision of stem cell processing by PCT, a third party; and other risks identified in Baxter’s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter’s website. Baxter does not undertake to update its forward-looking statements.

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Baxter Initiates Phase III Adult Stem Cell Clinical Trial for Chronic Cardiac Condition

Posted: February 28, 2012 at 2:58 pm

DEERFIELD, Ill.--(BUSINESS WIRE)--

Baxter International Inc. (NYSE:BAX - News) announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual’s own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).

Chronic myocardial ischemia (CMI) is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions.

“The prospect of using a person’s own adult stem cells to restore and repair blood flow in CMI is a very exciting concept based on a biological regenerative approach,” said Norbert Riedel, Ph.D., Baxter’s chief science and innovation officer. “The goals of this phase III trial are aligned with Baxter’s overall mission to develop life-saving and life-sustaining therapies and it will help us determine if the therapy can make a meaningful difference for CMI patients.”

The trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms: treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care. The primary objective is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with CMI, as measured by a change in total exercise capacity at 12 months following treatment. Secondary objectives include reduced frequency of angina episodes at 12 months after treatment and the safety of targeted delivery of the cells.

After stem cell mobilization, apheresis (collecting the cells from the body) and cell processing, participants will receive CD34+ stem cells or placebo in a single treatment via 10 intramyocardial injections into targeted areas of the heart tissue. Efficacy will be measured by a change in total exercise capacity during the first year following treatment and safety data will be collected for two years. Stem cell processing will be conducted in GMP facilities in the United States by Progenitor Cell Therapy (PCT), a subsidiary of NeoStem, Inc. To learn more or enroll, visit http://www.renewstudy.com or http://www.clinicaltrials.gov.

This trial is being initiated based on the phase II data, which indicated that injections of patients’ own CD34+ stem cells may improve exercise capacity and reduce reports of angina episodes in patients with chronic, severe refractory angina.

“The phase II trial provided evidence that this strategy, leveraging the body’s own natural repair mechanisms, can improve exercise capacity and reduce chest pain, the first time these endpoints have been achieved in a population of patients who have exhausted conventional treatment options,” said Douglas Losordo, MD, vice president of new therapeutic development at Baxter.

CD34+ cells, which are blood-forming stem cells derived from bone marrow, are comprised of endothelial progenitor cells (EPCs), which develop into new blood vessels. Previous preclinical studies investigating these cells have shown an increase in capillary density and improved cardiac function in models of myocardial ischemia.

About Baxter

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the use of adult autologous stem cells to treat CMI, including expectations with respect to the related phase III clinical trial. These statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: clinical results demonstrating the safety and effectiveness of the use of autologous stem cells to treat CMI; timely submission of regulatory filings; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; the enrollment of a sufficient number of qualified participants in the phase III clinical trial; the successful provision of stem cell processing by PCT, a third party; and other risks identified in Baxter’s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter’s website. Baxter does not undertake to update its forward-looking statements.

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Baxter Initiates Phase III Adult Stem Cell Clinical Trial for Chronic Cardiac Condition

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Report: Women have rare egg-producing stem cells

Posted: February 28, 2012 at 6:51 am

By LAURAN NEERGAARD
AP Medical Writer

WASHINGTON (AP) - For 60 years, doctors have believed women were born with all the eggs they'll ever have. Now Harvard scientists are challenging that dogma, saying they've discovered the ovaries of young women harbor very rare stem cells capable of producing new eggs.

If Sunday's report is confirmed, harnessing those stem cells might one day lead to better treatments for women left infertile because of disease - or simply because they're getting older.

"Our current views of ovarian aging are incomplete. There's much more to the story than simply the trickling away of a fixed pool of eggs," said lead researcher Jonathan Tilly of Harvard's Massachusetts General Hospital, who has long hunted these cells in a series of controversial studies.

Tilly's previous work drew fierce skepticism, and independent experts urged caution about the latest findings.

A key next step is to see whether other laboratories can verify the work. If so, then it would take years of additional research to learn how to use the cells, said Teresa Woodruff, fertility preservation chief at Northwestern University's Feinberg School of Medicine.

Still, even a leading critic said such research may help dispel some of the enduring mystery surrounding how human eggs are born and mature.

"This is going to spark renewed interest, and more than anything else it's giving us some new directions to work in," said David Albertini, director of the University of Kansas' Center for Reproductive Sciences. While he has plenty of questions about the latest work, "I'm less skeptical," he said.

Scientists have long taught that all female mammals are born with a finite supply of egg cells, called ooctyes, that runs out in middle age. Tilly, Mass General's reproductive biology director, first challenged that notion in 2004, reporting that the ovaries of adult mice harbor some egg-producing stem cells. Recently, Tilly noted, a lab in China and another in the U.S. also have reported finding those rare cells in mice.

But do they exist in women? Enter the new work, reported Sunday in the journal Nature Medicine.

First Tilly had to find healthy human ovaries to study. He collaborated with scientists at Japan's Saitama Medical University, who were freezing ovaries donated for research by healthy 20-somethings who underwent a sex-change operation.

Tilly also had to address a criticism: How to tell if he was finding true stem cells or just very immature eggs. His team latched onto a protein believed to sit on the surface of only those purported stem cells and fished them out. To track what happened next, the researchers inserted a gene that makes some jellyfish glow green into those cells. If the cells made eggs, those would glow, too.

"Bang, it worked - cells popped right out" of the human tissue, Tilly said.

Researchers watched through a microscope as new eggs grew in a lab dish. Then came the pivotal experiment: They injected the stem cells into pieces of human ovary. They transplanted the human tissue under the skin of mice, to provide it a nourishing blood supply. Within two weeks, they reported telltale green-tinged egg cells forming.

That's still a long way from showing they'll mature into usable, quality eggs, Albertini said.

And more work is needed to tell exactly what these cells are, cautioned reproductive biologist Kyle Orwig of the University of Pittsburgh Medical Center, who has watched Tilly's work with great interest.

But if they're really competent stem cells, Orwig asked, then why would women undergo menopause? Indeed, something so rare wouldn't contribute much to a woman's natural reproductive capacity, added Northwestern's Woodruff.

Tilly argues that using stem cells to grow eggs in lab dishes might one day help preserve cancer patients' fertility. Today, Woodruff's lab and others freeze pieces of girls' ovaries before they undergo fertility-destroying chemotherapy or radiation. They're studying how to coax the immature eggs inside to mature so they could be used for in vitro fertilization years later when the girls are grown. If that eventually works, Tilly says stem cells might offer a better egg supply.

Further down the road, he wonders if it also might be possible to recharge an aging woman's ovaries.

The new research was funded largely by the National Institutes of Health. Tilly co-founded a company, OvaScience Inc., to try to develop the findings into fertility treatments.

Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Report: Women have rare egg-producing stem cells

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Dental pulp stem cells transformed by 'bad breath’ chemical

Posted: February 28, 2012 at 6:51 am

ScienceDaily (Feb. 26, 2012) — Japanese scientists have found that the odorous compound responsible for halitosis -- otherwise known as bad breath -- is ideal for harvesting stem cells taken from human dental pulp.

In a study published 27 February, in IOP Publishing's Journal of Breath Research, researchers showed that hydrogen sulphide (H2S) increased the ability of adult stem cells to differentiate into hepatic (liver) cells, furthering their reputation as a reliable source for future liver-cell therapy.

This is the first time that liver cells have been produced from human dental pulp and, even more impressively, have been produced in high numbers of high purity. "High purity means there are less 'wrong cells' that are being differentiated to other tissues, or remaining as stem cells. Moreover, these facts suggest that patients undergoing transplantation with the hepatic cells may have almost no possibility of developing teratomas or cancers, as can be the case when using bone marrow stem cells," said lead author of the study Dr. Ken Yaegaki.

The remarkable transforming ability of stem cells has led to significant focus from research groups around the world and given rise to expectations of cures for numerable diseases, including Parkinson's and Alzheimer's.

In this study, Dr. Ken Yaegaki and his group, from Nippon Dental University, Japan, used stem cells from dental pulp -- the central part of the tooth made up of connective tissue and cells -- which were obtained from the teeth of dental patients who were undergoing routine tooth extractions.

Once the cells were sufficiently prepared, they were separated into two batches (a test and a control) and the test cells incubated in a H2S chamber. They were harvested and analysed after 3, 6 and 9 days to see if the cells had successfully transformed into liver cells. To test if the cells successfully differentiated under the influence of H2S, the researchers carried out a series of tests looking at features that were characteristic of liver cells.

In addition to physical observations under the microscope, the researchers investigated the cell's ability to store glycogen and then recorded the amount of urea contained in the cell. "Until now, nobody has produced the protocol to regenerate such a huge number of hepatic cells for human transplantation. Compared to the traditional method of using fetal bovine serum to produce the cells, our method is productive and, most importantly, safe" continued Dr. Yaegaki.

Hydrogen sulphide (H2S) has the characteristic smell of rotten eggs and is produced throughout the body in the tissues. Although its exact function is unknown, researchers have been led to believe that it plays a key role in many physiological processes and disease states.

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The above story is reprinted from materials provided by Institute of Physics (IOP), via AlphaGalileo.

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

Journal Reference:

Nikolay Ishkitiev, Bogdan Calenic, Izumi Aoyama, Hisataka Ii, Ken Yaegaki, Toshio Imai. Hydrogen sulfide increases hepatic differentiation in tooth-pulp stem cells. Journal of Breath Research, 2012; 6 (1): 017103 DOI: 10.1088/1752-7155/6/1/017103

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

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Dental pulp stem cells transformed by 'bad breath’ chemical

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