Category Archives: Diseases

To: HEALTH, LEGAL AFFAIRS AND MEDICAL EDITORS

WASHINGTON, Feb. 28, 2012 /PRNewswire-USNewswire/ -- This week the Genetics Policy Institute (GPI) joined the Coalition for Advancement of Medical Research (CAMR) in filing an amicus curiae ("friend of the court") brief in the United States Court of Appeals for the District of Columbia Circuit, supporting federal funding for human embryonic stem cell research.

GPI previously filed amicus briefs in the United States District Court and in the Court of Appeals, the latter in collaboration with CAMR and the State of Wisconsin. Both earlier briefs focused on the preliminary injunction in the case.

Bernard Siegel, GPI's executive director, stated, "Our brief supports the District Court's ruling on behalf of the government upholding federal funding for human embryonic stem cell research. We make clear that the NIH complied with the Administrative Procedures Act in adopting stem cell research rules. The brief also focused upon arguments relating to statutory interpretation of the Dickey-Wicker Amendment, maintaining that the government has a complete right to fund research on ethically derived stem cell lines."

GPI's mission is to promote and defend stem cell research and its application in medicine to develop therapeutics and cures for many otherwise intractable diseases and disorders. GPI pursues this mission through production of its flagship annual World Stem Cell Summit, publication of the World Stem Cell Report, special projects, speaking engagements, online newsletters and strategic collaborations. Among its initiatives, GPI maintains the Stem Cell Action Coalition, an alliance of 75 independent organizations, including patient groups, academic institutes, medical philanthropies and science and medical societies, all supporting stem cell research targeting cures.

SOURCE Genetics Policy Institute

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Genetics Policy Institute (GPI) Files Additional Legal Arguments in Sherley v. Sebelius Stem Cell Case

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)

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 individuals 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 persons 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., Baxters chief science and innovation officer. The goals of this phase III trial are aligned with Baxters 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 bodys 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

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

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

28-10-2011 21:43 [Anchor] With the increasing number of the patients who suffer from the hard-to-cure diseases, various treatments have been tried for eliminating the cause. Recently, the "umbilical cord blood stem cells" are brought up to be the new solutions and give hope to the patients. Our next report has the details. [Reporter] The stem cells are basic cells for making about two hundred and sixty of body cells such as bones, bloods, and nerves. By duplicating themselves, the stem cells restore the damaged cells. Among them, especially, the umbilical cord blood stem cells are highly effective on curing the hard-to-cure diseases. Those cells, which have the functions to investigate and chase the specific cells, are from the cellular tissue of the umbilical cord. With this, it is possible to load the anti-cancer genes or healing substances so as to fight off the germs selectively. [Interview - Won-il Oh, Director of Research of MEDIPOST] ~ The umbilical cord blood stem cells go inside of the body and find the affected area with specific disease. It is used for curing the incurable diseases like stroke, brain tumor and arthritis. The "umbilical cord blood stem cell therapy products" regenerate the cells and tissues that are damaged from diseases. Since the products are made from the adult stem cells extracted from the cord blood, the differentiation with the existing medicine is expected. Along with this, the number of people who are using the "cord blood bank" has been increasing ...

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The umbilical cord blood stem cells break new ground in healing hard-to-cure diseases - Video

By Noimot Olayiwola
Staff Reporter
Researchers and scientists in the field of both embryonic and adult stem cells research in the Middle East were yesterday urged to be more open to collaboration and networking among themselves in order to build on their already acquired and existing strengths for the betterment of the future use of stem cells in curing genetic diseases in the region.
Stem cells are ‘unspecialised’ cells that are able to divide and produce copies of themselves and having the potential to differentiate, that is, to produce other cell types in the body.
Speaking on how to further expand the scope of stem cell research in the region during a panel discussion yesterday at the ongoing Qatar International Conference on Stem Cell Science and Policy, Weill Cornell Medical College in Qatar’s Dr Jeremie Arash Rafii Tabrizi said there was the need for the region’s researchers in the field of stem cells to know each other and come together to network and form collaborations.
“I believe that each and everyone in the field within this region has built some sort of strength while conducting their individual researches, so I will suggest that we all come together to put heads together and also explore how we can benefit from our colleagues elsewhere. And if we can be more diseases-focused in our researches, I believe it is a good way to move forward,” he noted.
Making a presentation on “Stem Cell Research: From Promise to Practice”, Dr Aida al-Aqeel, of Riyadh Military Hospital’s paediatrics department, maintained that it would take a while before stem cell research can become a ‘clinical reality’.
“Despite that stem cell research is at the forefront of the need for research to cure most degenerative diseases, it will still take a long way for the stem cell research to become achievable clinically because the embryonic stem cells (ESCs) have huge therapeutic potential as they can give rise to every cell type in the body (pluripotency) as compared to adult stem cells (ASCs) from certain adult tissues that can only differentiate into a limited range of cell types,” she said.
“However, this research raises sensitive ethical and religious arguments, which are balanced against possible great benefit of such research for the patients suffering from so far incurable diseases. Serious questions remain about safety,” she said, noting that the ability for stem cells to be expanded in culture without genetic and epigenetic abnormalities and their ability to form functional cell types in vitro and in vivo, and their immuno-compatibility with the patient still need to be studied.
“In Saudi Arabia, for the last five years, the Stem Cell Therapy Programme has been established at King Faisal Specialist Hospital and Research Centre with the launch of 10 projects. Embryonic stem cell therapy for genetics metabolic disorders is one of the most promising modalities for the therapy and prevention of mentally and physically handicapped in children,” she said while sharing experiences from the KSA.
She pointed out how Islamic teachings make embryonic stem cell research and therapeutic technique, and its modality of treatment permissible as well as the Islamic perspectives about reproductive/therapeutic cloning.
“The focus of research community should be on developing human research capacity in both ASCs and ESCs. Each type of research will take time to mature. The ethical debate will need to produce acceptable policy and regulatory compromises so that the regulatory burden can be reduced and investors’ risk aversion can be overcome,” she stated.
Other speaker during the session moderated by WCMC-Q dean Dr Javaid Sheikh were Professor Hossein Baharvand from the Royan Institute for Reproductive Biomedicine Stem Cell Biology and Technology on “A Chemical Approach to Efficient Generating Embryonic and Germline-derived Pluripotent Stem Cells”.

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Scientists urged to share data on stem cells research