Stem cell study ‘should aim at innovation in treatment’

By Bonnie James Deputy News Editor The stem cell and regenerative therapy programme, constituting a major part of research at Qatar Cardiovascular Research Centre (QCRC), has important clinical and scientific implications, co-chairman Prof Sir Magdi Yacoub has said. He was giving a keynote presentation at the Qatar International Conference on Stem Cell Science and Policy 2012, which concluded on Thursday at Qatar National Convention Centre. Myocardium (the muscular tissue of the heart) regeneration and tissue engineering and valves tissue engineering are among the focal areas at QCRC, which aims to establish in Qatar an internationally competitive centre of excellence for cardio-vascular research. QCRC, which has a heart muscle lab and a tissue engineering, regeneration lab, works with a mission to maintain a translational focus, relevant to the development of health policy and practice, and provide opportunities for capacity building, professional development and research collaborations in Qatar. It is also meant to provide opportunities for biotechnology development in Qatar and contribute to cardio-vascular health in the developing world through improved knowledge base, capacity building and development of appropriate tools and strategies focused on poorer countries. Cardio-vascular diseases (CVDs) kill 17mn people per year globally and there is particularly high incidence in the Middle East and Gulf region, Prof Yacoub pointed out. The incidence of CVDs is three times more in the region than in the UK, the US or Europe. Smoking, one of the main reasons for CVDs, is also increasing in the eastern Mediterranean region compared to the Americas. There is a significant lack of clinical, epidemiological and genetic data from this region and an overwhelming need exists to better understand epidemiology and disease mechanisms of CVDs. Research should then be linked to development of appropriate tools and strategies to strengthen prevention, diagnosis and treatment, he said. Pointing out that heart transplant options for those suffering from severe heart failure are becoming increasingly rare, Prof Yacoub observed that the number of donor hearts is going down globally. While we used to do up to 130 heart transplants a year at Royal Brompton and Harefield Hospitals in the UK in the late 80s, now we would be lucky to do 20, he said while emphasising the need to focus more on the reversibility of heart failure. Few recent drug trials have shown evidence of minor reverse remodelling and there have been near-complete reversal of almost every change in myocardium in some patients. There are unprecedented opportunities to unravel the secrets of heart failure at cellular and molecular levels, he stressed.

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Stem cell study ‘should aim at innovation in treatment’

Pat was Diagnosed with “CMT” Disease and was Given a Second Chance with a Stem Cell Treatment

Pat receive a life altering Stem Cell Treatment with the help of World Stem Cells, LLC. Pat went from couch bound to walking 1.5 miles on country dirt road, climbing stairs, gardening and playing piano all thanks to a stem cell treatment.

(PRWEB) March 03, 2012

Pats neurological disorder is hereditary, and the official position of the National Institute of Neurological Disorders and Stroke is that CMT has no cure. Decades ago, Pat had gone to a neurologist for electromyography, or EMG. The purpose of the procedure was to evaluate her muscle function, and it involved painful needles and days of muscle soreness after each session. Pats neurologist had refused to tell her the results because he said that she would just give up if she knew how bad they were. At this point, Pats symptoms were so crippling and unbearable that she contacted World Stem Cells, LLC worldstemcells.com to explore stem cell treatment as an option. She knew that the procedures were still being developed and experimental, and that they came with no guarantees. She remained interested in learning more and becoming educated on the options presented. At the time, she was unable to walk without a four-leg quad cane, and air and car travel were exhausting and caused unbearable pain. Pat has a long history of surgeries and was told that further surgeries would not assist her. She decided that she was not interested in any treatment that involved surgery with incisions, which is an aggressive approach and would demand recovery time. Stem cell therapy met her requirements of being minimally uncomfortable, requiring only hours for recovery and having a high level of safety, along with a good potential for changing her health quotient for the better.

Pat arrived in Cancun, Mexico, to the treatment site of World Stem Cells, LLC contract clinics, doctors, and hospitals. The first day, she met with physicians to be evaluated, discuss her course of treatment and learn what to expect. She had been corresponding with Dr. Alan Kadish, the President of World Stem Cells, LLC. worldstemcells.com

Dr. Kadish is an unusual physician as he has training and practiced integrated primary care medicine combining conventional and naturopathic diagnostics and therapeutics for 27 years. He has been recognized as one of the leading quality physicians, in his field. Dr. Kadish is an American Board of Anti-Aging Medicine diplomat and completed numerous training programs in Achieving Clinical Excellence, or ACE, which provided opportunities to improve his practical skills in diagnosing and treating people based on their individual needs, using functional medical testing and treatment. He has been an advanced level practitioner (Autistic Research Institute) for autistic spectral disorder children and adults, since early 2000 and is certified in chelation therapy. As a naturopathic medical physician he lecturers frequently and is a host and guest on radio and internet outlets along with appearing in a number of print media publications. At World Stem Cells , LLC in addition to his management duties, he is a primary investigator engaged in research and designs of stem cell therapeutic protocols.

In Cancun, Pat met with specialists at Advanced Cellular Medicine Clinic. The clinic is headed by Dr. Sylvia Abblitt, who has the exclusive distinction of being among the few physicians who are licensed to perform autologous and allogeneic stem cell transplants in Mexico. Dr. Abblitt is a board-certified hematologist and oncologist. She has 11 years of expertise as a laboratory director and head of the hematology department at the Fernando Quiroz Hospital. She is a member of the American Association of Blood Banks and the International Cellular Medicine Society (ICMS). The Cancun clinic that Pat visited is a contract clinic of World Stem Cells, LLC. It houses the state-of-the-art Advanced Cellular Engineering Lab. The high-tech lab is suited for providing patients with the most up to date stem cell treatments and for conducting stem cell research to improve future opportunities for health.

After her evaluation and discussion of treatment options, Pat decided to go ahead with the stem cell therapy. The procedure involved a needle puncture to harvest her bone marrow utilizing her own stem cells. Only a local anesthesia was necessary and though she described the procedure as uncomfortable, she added that it was livable. The procedure took less than half an hour, and she experienced no side effects.

Pats improvement was remarkable and rapid. In fact, she did not feel fatigued and overwhelmed with pain, as she had in the past, when she traveled back home from Cancun by airplane and car. Within days, she had regained her ability to play piano. Playing at church concerts had always been a passion of hers, but she had been unable to play before her stem cell treatment because of a lack of coordination. She had much more energy after treatment, and was able to garden, run errands and work, without feeling exhausted. Her sleep was more restful. Her husband and friends noticed that her agility and balance were better. She could climb up and down stairs more easily and walk around the house without clutching the walls. Her speed on the treadmill was increasing gradually and she now walks a mile and a half on country roads.

Pat is extremely grateful to World Stem Cells, LLC for changing her life and giving her hope. For the first time, she has reversed many of the negative changes that she had been experiencing for years due to her CMT and lack of effective treatment. Now, Pat and her husband are experiencing a bright future and thankful that Pat was given this second opportunity, following stem cell therapy. worldstemcells.com.

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Pat was Diagnosed with “CMT” Disease and was Given a Second Chance with a Stem Cell Treatment

Groundbreaking discovery on stem cell regulation

ScienceDaily (Mar. 1, 2012) A*STAR scientists have for the first time, identified that precise regulation of polyamine[1] levels is critical for embryonic stem cell (ESC) self-renewal -- the ability of ESCs to divide indefinitely -- and directed differentiation. This paper is crucial for better understanding of ESC regulation and was published in the journal Genes & Development on 1st March by the team of scientists from the Institute of Medical Biology (IMB), a research institute under the Agency for Science, Technology and Research (A*STAR).

Embryonic stem cells hold great potential for the development of cellular therapies, where stem cells are used to repair tissue damaged by disease or trauma. This is due to their unique ability to renew themselves and differentiate into any specific types of cell in the body. One of the challenges with cellular therapies is ensuring that ESCs are fully and efficiently differentiated into the correct cell type. This study sheds light on understanding how ESCs are regulated, which is essential to overcome these challenges and turn the vision of cell therapies into reality.

Using a mouse model, the team of scientists from IMB showed that high levels of Amd1[2], a key enzyme in the polyamine synthesis pathway, is essential for maintenance of the ESC state and self renewal of ESCs. To further demonstrate the critical role of Amd1 in ESC self-renewal, the scientists showed that increasing Amd1 levels led to delayed ESC differentiation. The research also revealed that downregulation of Amd1 was necessary for differentiation of ESCs into neural precursor cells and that Amd1 is translationally regulated by a micro-RNA (miRNA), the first ever demonstration of miRNA-mediated regulation of the polyamine pathway.

While the polyamine pathway is well established and polyamines are known to be important in cancer and cell proliferation, their role in ESC regulation until now was unknown. This novel discovery, linking polyamine regulation to ESC biology, came about when the team set up a genome-wide screen to look for mRNAs under translational control in order to identify new regulators of ESC differentiation to neural precursor cells.

Dr Leah Vardy, principle investigator at the IMB and lead author of the paper, said, "The polyamines that Amd1 regulate have the potential to regulate many different aspects of self renewal and differentiation. The next step is to understand in more detail the molecular targets of these polyamines both in embryonic stem cells and cells differentiating to different cellular lineages. It is possible that manipulation of polyamine levels in embryonic stem cells through inhibitors or activators of the pathway could help direct the differentiation of embryonic stem cells to more clinically useful cell types."

Notes:

[1] Polyamines are required for a wide range of cellular processes, including differentiation and cell proliferation, and their levels are tightly regulated.

[2] Amd1 (Adenosyl methionine decarboxylase) is a critical enzme required for the synthesis of the polyamines spermine and spermidine.

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Dr. Ali Denktas discusses stem cell treatment for heart attack patients – Video

29-02-2012 09:25 In this video, UTHealth/Memorial Hermann's Dr. Ali Denktas discusses stem cell treatment for heart attack patients. Watch to learn more about the procedure and results.

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Dr. Ali Denktas discusses stem cell treatment for heart attack patients - Video

Cell and signaling pathway that regulates the placental blood stem cell niche identified

ScienceDaily (Mar. 1, 2012) UCLA stem cell researchers have discovered a critical placental niche cell and signaling pathway that prevent blood precursors from premature differentiation in the placenta, a process necessary for ensuring proper blood supply for an individual's lifetime.

The placental niche, a stem cell "safe zone," supports blood stem cell generation and expansion without promoting differentiation into mature blood cells, allowing the establishment of a pool of precursor cells that provide blood cells for later fetal and post-natal life, said study senior author Dr. Hanna Mikkola, an associate professor of molecular cell and developmental biology and a researcher at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA.

Mikkola and her team found that PDGF-B signaling in trophoblasts, specialized cells of the placenta that facilitate embryo implantation and gas and nutrient exchanges between mother and fetus, is vital to maintaining the unique microenvironment needed for the blood precursors. When PDGF-B signaling is halted, the blood precursors differentiate prematurely, creating red blood cells in the placenta, Mikkola said.

The study, done in mouse models, appears March 1, 2012, in the peer-reviewed journal Developmental Cell.

"We had previously discovered that the placenta provides a home for a large supply of blood stem cells that are maintained in an undifferentiated state. We now found that, by switching off one signaling pathway, the blood precursors in the placenta start to differentiate into red blood cells," Mikkola said. "We learned that the trophoblasts act as powerful signaling centers that govern the niche safe zone."

The study found that the PDGF-B signaling in the trophoblasts is suppressing production of Erythropoietin (EPO), a cytokine that controls red blood cell differentiation.

"When PDGF-B signaling is lost, excessive amounts of EPO are produced in the placenta, which triggers differentiation of red blood cells in the placental vasculature," said Akanksha Chhabra, study first author and a post-doctoral fellow in Mikkola's lab.

Mikkola and Chhabra used mouse models in which the placental structure was disrupted so they could observe what cells and signaling pathways were important components of the niche.

"The idea was, if we mess up the home where the blood stem cells live, how do these cells respond to the altered environment," Chhabra said. "We found that it was important to suppress EPO where blood stem cell expansion is desired and to restrict its expression to areas where red blood cell differentiation should occur."

The finding, Chhabra said, was exciting in that one single molecular change "was enough to change the function of an important blood stem cell niche."

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Cell and signaling pathway that regulates the placental blood stem cell niche identified

Stem-Cell Therapy Takes Off in Texas

By David Cyranoski of Nature magazine

With Texas pouring millions of dollars into developing adult stem-cell treatments, doctors there are already injecting paying customers with unproven preparations, supplied by an ambitious new company.

The US Food and Drug Administration (FDA) has not approved any such stem-cell treatment for routine clinical use, although it does sanction them for patients enrolled in registered clinical trials. Some advocates of the treatments argue, however, that preparations based on a patient's own cells should not be classed as drugs, and should not therefore fall under the FDA's jurisdiction.

There are certainly plenty of people eager to have the treatments. Texas governor Rick Perry, for instance, has had stem-cell injections to treat a back complaint, and has supported legislation to help create banks to store patients' harvested stem cells.

One company that has benefited from this buoyant climate is Celltex Therapeutics, which "multiplies and banks" stem cells derived from people's abdominal fat, according to chairman and chief executive David Eller. Its facility in Sugar Land, just outside Houston, opened in December 2011 and houses the largest stem-cell bank in the United States.

Celltex was founded by Eller and Stanley Jones, the orthopaedic surgeon who performed Perry's procedure, and it uses technology licensed from RNL Bio in Seoul. Because clinical use of adult-stem-cell treatments are illegal in South Korea, RNL has since 2006 sent more than 10,000 patients to clinics in Japan and China to receive injections.

Celltex says that although it processes and banks cells, it does not carry out stem-cell injections. It declined to answer Nature's questions about whether its cells have been used in patients. But there is evidence that the company is involved in the clinical use of the cells on US soil, which the FDA has viewed as illegal in other cases.

Public hype

In addition to the publicity surrounding Perry's treatment, a woman named Debbie Bertrand has been blogging about her experiences during a five-injection treatment with cells prepared at Celltex. Her blog (http://debbiebertrand.blogspot.com) hosts photographs of herself alongside Jones; Jennifer Novak, a Celltex nurse; Jeong Chan Ra, chief executive of RNL Bio; and her doctor, Jamshid Lotfi, a neurologist who works for the United Neurology clinic in Houston. Another photo is captioned: "My cells are being processed in here for my next infusion!!!" A third shows Bertrand, Lotfi and a physician called Matthew Daneshmand, who is, according to the caption, injecting Bertrand's stem cells into an intravenous drip, ready for the infusion. Nature has been unable to contact Bertrand.

Lotfi says that he has administered cells processed by Celltex to more than 20 people. "Five or six" -- including Bertrand -- have multiple sclerosis and "four or five" have Parkinson's disease, he says. Lotfi explains that patients sign up for treatment by contacting Novak, and that cells are prepared by removing about five grams of fat -- containing roughly 100,000 mesenchymal stem cells -- from the patient's abdomen. Over a three-week period, the cells are cultured until they reach about 800 million cells. Lotfi says that patients get at least three injections of 200 million cells each, and that the cells do not take effect for a few months. According to Lotfi, Celltex charges US$7,000 per 200 million cells, and pays Lotfi $500 per injection.

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Stem-Cell Therapy Takes Off in Texas

Baxter Begins Phase III Adult Stem Cell Trial For Chronic Cardiac Condition

(RTTNews.com) - Baxter International Inc. (BAX) said it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia.

Chronic myocardial ischemia 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.

The company said that the trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms, namely 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 chronic myocardial ischemia, as measured by a change in total exercise capacity at 12 months following treatment.

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.

The company noted that the 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.

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Baxter Begins Phase III Adult Stem Cell Trial For Chronic Cardiac Condition

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

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

Experts discuss stem cell banking ethics, policies

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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Experts discuss stem cell banking ethics, policies

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

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