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

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

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 ...