Category Archives: Stem Cell Therapy

Public release date: 11-Oct-2012 [ | E-mail | Share ]

Contact: David McKeon dmckeon@nyscf.org 212-365-7440 New York Stem Cell Foundation

NEW YORK, NY (October 11, 2012) For the second day, The New York Stem Cell Foundation (NYSCF) Seventh Annual Translational Stem Cell Research Conference hosts the world's most preeminent stem cell scientists to present their findings on how advances in stem cell science lead to better treatments and cures for disease and injury. The conference is held at The Rockefeller University in Manhattan on October 10-11.

Today, in disease-specific sessions, scientists will share their latest finds in moving stem cell research to treatments in the following areas: cancer and blood disease; diabetes and autoimmunity; heart and muscles; neurodegeneration and spinal cord injury.

In Cancer and Blood Disease, Elaine Fuchs, PhD, The Rockefeller University, will share findings on identification of skin cancer stem cells, which have implications in understanding other cancers as well as stem cells. Joanne Kurtzberg, MD, Duke University, will discuss her work developing therapies for disease with autologous cord blood transplants. Ravi Majeti, PhD, Stanford University, will describe his recent insights into acute myeloid leukemia and how stem cell technologies can lead to new cancer treatments.

Dieter Egli, PhD, The New York Stem Cell Foundation (NYSCF), will open the session on Diabetes and Autoimmunity by detailing his group's development of stem cell-derived models of pancreatic beta cells for the study of diabetes. Yuval Dor, PhD, Hebrew University, Israel, will discuss experiments with pancreatic beta cells with the goal to understand the regenerative potential of these cells. Matthias von Herrath, MD, Novo Nordisk, will delve into another aspect of Type 1 diabetes, the problem of autoimmunity. He will close the session by sharing insights into the need for an immune modulated therapy to diabetes.

Before the afternoon sessions, Shahin Rafii, MD, Weill Medical College of Cornell University will deliver the first of two keynote addresses of the conference. He will describe his recent successes in deriving vascular cells from amniotic cells.

In the afternoon session on Heart and Muscle Diseases, Amy Wagers, PhD, Harvard University, will focus on advances in treatments and explain how studies into the mechanisms of tissue stem cell renewal may have relevant therapeutic implications. Gordon Keller, PhD, McEwen Centre for Regenerative Medicine, Canada, will describe modeling cardiac cell development from human pluripotent cells for use in toxicology and electrophysiology studies. Helen Blau, PhD, Stanford University, will describe her research to improve stem cell culture in the direction of stem cell fate and for drug screens.

In Neurodegeneration and Spinal Cord Injury, Paola Arlotta, PhD, Harvard University and a NYSCF-Robertson Stem Cell Investigator, will address the application of stem cells to understanding and possibly treating these debilitating diseases and conditions, and will describe investigations to direct reprogramming of neurons into different neuronal lineages. Lorenz Studer, MD, Memorial Sloan-Kettering Cancer Center, will discuss the potential stem cell technology holds in the treatment of Parkinson's disease. Despite past failures in the replacement of lost dopamine neurons, Dr. Studer will describe his novel protocols for the generation of these neurons for eventual use in clinical trials.

Rudolf Jaenisch, MD, The Whitehead Institute, will deliver the second keynote address of the day. Building on Shinya Yamanaka's paradigm-changing work in induced pluripotent stem (iPS) cell reprogramming, Dr. Jaenisch will discuss new methods to counter the generally low successful output of these cells. He will also summarize how targeted genome editing may help unleash the potential of iPS cells and embryonic stem cells for both the study of and therapy for disease.

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Scientists discuss stem cell discoveries at New York Stem Cell Foundation Conference

Public release date: 11-Oct-2012 [ | E-mail | Share ]

Contact: Deborah Mann Lake deborah.m.lake@uth.tmc.edu University of Texas Health Science Center at Houston

HOUSTON (Oct. 11, 2012) Early results of a Phase II intra-arterial stem cell trial for ischemic stroke showed no adverse events associated with the first 10 patients, allowing investigators to expand the study to a targeted total of 100 patients.

The results were presented today by Sean Savitz, M.D., professor of neurology and director of the Stroke Program at The University of Texas Health Science Center at Houston (UTHealth), at the 8th World Stroke Congress in Brasilia, Brazil.

The trial is the only randomized, double-blind, placebo-controlled intra-arterial clinical trial in the world for ischemic stroke. It is studying the safety and efficacy of a regenerative therapy developed by Aldagen Inc., a wholly-owned subsidiary of Cytomedix, Inc., that uses a patient's own bone marrow stem cells, which can be administered between 13 and 19 days post-stroke.

The therapy, called ALD-401, consists of stem cells that are identified using Aldagen's proprietary technology to isolate cells that express high levels of an enzyme that serves as a marker of stem cells. Pre-clinical studies found that these cells enhance recovery after stroke in mice. The cells are administered into the carotid artery. Patients are followed for 12 months to monitor safety and to assess mental and physical function.

"We have been approved by the Data Safety Monitoring Board (DSMB) to move the study into the next phase, which will allow us to expand the number of sites in order to complete enrollment," said Savitz, senior investigator for the multi-center study. As per the protocol for the trial, the Food and Drug Administration required a review by the DSMB prior to advancing to the next phase.

Preclinical research, including research at the UTHealth Medical School, has suggested that stem cells can promote the repair of the brain after an ischemic stroke, which is caused by a blood clot in the brain. Stroke is a leading cause of disability and the fourth-leading cause of death in the United States, according to 2008 statistics reported by the Centers for Disease Control and Prevention.

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For patient information about the intra-arterial stem cell clinical trial for stroke, call 713-500-7183 or email jennifer.m.garrett@uth.tmc.edu.

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Safety results of intra-arterial stem cell clinical trial for stroke presented

SAN DIEGO & MINNEAPOLIS--(BUSINESS WIRE)--

Cytori Therapeutics (CYTX) announced the initiation of the FDA approved ATHENA clinical trial to investigate Cytoris cell therapy in patients who suffer from a severe form of refractory (untreatable) heart failure due to chronic myocardial ischemia. Cytoris cell therapy is based on a patients own adipose-derived stem and regenerative cells (ADRCs) processed by the Companys proprietary Celution System technology, making this the first FDA approved trial in the U.S. to evaluate ADRCs for cardiovascular disease. This first patient was treated by co-principal investigator Timothy Henry, M.D., Director of Research, at the Minneapolis Heart Institute Foundation in September and has undergone a seven day follow-up assessment. More details on the ATHENA trial may be found at http://www.theathenatrial.com.

Patients with refractory heart failure have no options except for heart transplant, for which there are few hearts available, said Dr. Henry. Cell therapy such as Cytoris has the potential to delay, halt, or even reverse this progression. We believe this is accomplished by the cells ability to promote angiogenesis and regulate the immune response to help revive damaged tissue that is alive yet not necessarily contributing to its fullest capacity toward the pumping ability of the heart.

ATHENA is a device-based, multi-center, prospective, randomized, double-blind PMA/IDE safety and feasibility (Phase I/II) trial that will enroll 45 patients in six centers in the U.S. Patients will be randomized to receive either Cytoris cell therapy (n=30) or an inactive placebo injection (n=15). All trial participants will undergo a minor liposuction procedure to remove adipose tissue. The adipose tissue will then be processed at the point-of-care with Cytoris proprietary system to separate and concentrate clinical-grade ADRCs. The treatment group will have a prescribed dose of the patients own ADRCs (0.4 million cells/kg body weight), which will then be injected into their damaged heart tissue using a minimally invasive catheter system.

Cytoris cell therapy has unique advantages compared to alternate cell sources such as bone marrow and peripheral blood, said Emerson Perin, M.D., Ph.D. of The Texas Heart Institute and co-principal investigator for ATHENA. Specifically, its a proprietary formulation that Cytori has optimized for vascular delivery and which contains an uncultured and mixed population of cells. As a result, this increases the number of cell types that potentially contribute to repair relative to a more homogenous population of cultured cells.

The trial will measure several endpoints, including peak oxygen consumption (VO2 Max). VO2 Max is an objective functional measurement that can be predictive of outcomes in heart disease, including mortality, and is commonly used as a primary determinant for qualifying patients for heart transplantation. Additional endpoints include perfusion defect, left ventricle end-systolic and diastolic volume and ejection fraction at six and 12 months. ATHENA will also evaluate medical economic factors such as rate of re-hospitalization and heart failure symptoms such as angina and quality of life at 12 months.

We believe Cytoris cell therapy will improve patient outcomes, said Marc H. Hedrick, M.D., president, Cytori Therapeutics. In ATHENA, investigators will be delivering a virtually off-the-shelf cell therapy comprised of a patients own cells, which is made possible by our technology. Using a patients own cells minimizes the risk of rejection or disease transmission compared to alternative therapies derived from donor cells and the virtually off-the-shelf nature allows the treatment to be accomplished in a single surgical procedure.

Cytori received approval from the FDA for its Investigational Device Exemption (IDE) application to begin ATHENA in January 2012 and the trial is currently expected to complete enrollment in mid-2013. In addition to Minneapolis Heart Institute Foundation, the Texas Heart Institute (Houston, TX) is actively screening patients under the direction of Emerson Perin, M.D., Ph.D., co-principal investigator for ATHENA, and James T. Willerson, M.D. Four additional centers are also expected to participate in the trial including:

Previously, Cytori reported six and 18-month safety and feasibility data from the PRECISE trial, a European clinical trial for this same indication. The PRECISE trial demonstrated a statistically significant improvement in VO2 Max in patients treated with Cytoris cell therapy compared to those treated with placebo. The Company is also conducting the ADVANCE trial, a European pivotal trial investigating the effect of Cytoris cell therapy in heart attack patients.

Refractory Heart Failure

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First Patient Treated in Cytori’s U.S. Cell Therapy Heart Failure Trial

WASHINGTON, Oct. 10, 2012 /PRNewswire-USNewswire/ --Alliance Defending Freedom and the Jubilee Campaign together with Tom Hungar of Gibson, Dunn & Crutcher today filed a petition for certiorari with the U.S. Supreme Court in the case Sherley v. Sebelius, which seeks to end federal funding of human embryonic stem cell research.

Of the petition David Prentice, Ph.D., senior fellow for life sciences at the Family Research Council's Center for Human Life and Bioethics, made the following comments:

"Even as the Nobel Prize committee honors Japanese scientist Shinya Yamanaka for introducing ethical induced pluripotent stem (iPS) cells to the field of medicine, the Obama administration is fighting to continue wasting taxpayer money on unethical embryonic stem cell research, which relies on the destruction of young human life. A plain reading of federal law would specifically prohibit funding of embryonic stem cell research. After years of wasting taxpayer dollars as well as lives on ethically-tainted experiments, it's time for the federal government to start putting that money into lifesaving and ethical adult stem cell research, the gold standard for patient treatments. Such research is saving thousands of lives now lives like that of Chloe Levine who beat cerebral palsy with the help of adult stem cells. Each precious life at every stage and every age deserves our respect, and we should devote our resources and time to the ethical stem cell research that has the best chance of preserving life adult stem cells.

"We are pleased to see this suit move forward, and hope that the Supreme Court will agree to its review and uphold the clear intent of federal law to protect human life from experimentation."

To watch a video about Chloe Levine and adult stem cell therapy, click here : http://www.youtube.com/watch?feature=player_embedded&v=ojjT4yRd5Es

To learn more about adult stem cells, click here : http://www.stemcellresearchfacts.org/

SOURCE Family Research Council

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FRC Supports Alliance Defending Freedom, Jubilee Campaign Cert Petition to Supreme Court on Stem Cell Funding

LA JOLLA, Calif., Oct. 10, 2012 /PRNewswire/ --New research directions are being explored to find therapies for hard to treat diseases. One exciting new approach is the use of autologous Adult Stem Cells. Multiple Sclerosis (MS) is one of the many notable diseasesadult stem cell therapycould potentially impact. Multiple Sclerosis (MS) is a disorder in which an individual's own immune system attacks the 'myelin sheath'. The myelin sheath serves to protect the nerve cells within the body's central nervous system (CNS). The damage caused by MS may result in many types of symptoms including:

(Photo: http://photos.prnewswire.com/prnh/20121010/LA89802-INFO)

Currently there is no cure for MS, but MS stem cell therapiesattempt to slow the disease's progression and limit symptoms. Since adult stem cells have the ability to differentiate into many different types of cells, such as those required for proper functioning and protection of nerve cells, the use of adult stem cells for MS therapy could be of substantial value. Adult stem cells can be isolated with relative ease from an individual's own 'adipose' (fat) tissue. As a result, adult stem cell therapy is not subject to the ethical or religious issues troubling embryonic methods.

Encouragingly for MS treatment potential, scientific researchers have been studying the properties of adipose-derived stem cells. Their results from canine and equine studies suggest anti-inflammatory and regenerative roles for these stem cells. Also, further research findings suggest these adipose-derived stem cells can have specific immune-regulating properties. Markedly, clinical-based work conducted overseas has indicated that individuals suffering from MS could respond well to adipose-derived stem cell treatment, with a substantially improved quality of life.

The US based company, StemGenex, is pioneering new methods for using adipose derived adult stem cells to help in diseases with limited treatment options like MS. StemGenex has been conducting research with physicians over the last 5 years to advance adult stem cell treatment protocols for alleviating MS symptoms. StemGenex's proprietary protocol includes the use of a double activation process, which increases both the viability and the quantity of stem cells that are received in a single application.

To find out more about stem cell treatments contact StemGenex either by phone at 800.609.7795 or email at Contact@StemGenex.com.

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StemGenex™ on Adult Stem Cell-Based Therapy for Multiple Sclerosis

NEW YORK, Oct. 10, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), an emerging leader in the fast growing cell therapy market, announced today that a new article published by the International Scholarly Research Network provides further evidence that AMR-001, NeoStem's lead product candidate through its Amorcyte subsidiary, appears capable of preserving heart muscle function following a large myocardial infarction. Amorcyte demonstrated in its Phase 1 trial that AMR-001 preserved heart muscle function when a therapeutic dose of cells was administered. No patient experienced a deterioration in heart muscle function who received 10 million cells or more whereas 30 to 40 percent of patients not receiving a therapeutic dose did. The new study shows that cardiac muscle function sparing effects are evident even earlier after treatment than previously shown.

The article titled "Assessment of myocardial contractile function using global and segmental circumferential strain following intracoronary stem cell infusion after myocardial infarction: MRI Feature Tracking Feasibility Study" by Sabha Bhatti, MD, et al. appears in ISRN Radiology Volume 2013, Article ID 371028 and is published online at http://www.isrn.com/journals/radiology/2013/371028. The publication by Dr. Bhatti and colleagues, including Dr. Andrew Pecora, Chief Medical Officer of NeoStem, supports the finding that AMR-001 preserves heart function. Previously, Amorcyte, a NeoStem subsidiary, showed that six months after STEMI AMR-001 improved blood flow to the heart and preserved heart muscle. By using cardiac magnetic resonance imaging, specifically measuring circumferential strain of the left ventricle, the authors show that AMR-001's effects are evident by three months after STEMI.

AMR-001's angiogenic and anti-apoptotic mechanisms of action indicate that preservation of heart muscle function should start within weeks and be evident in fewer than 6 months. This publication, based on blinded analysis of Amorcyte's Phase 1 data, confirms the expected time course for AMR-001's mechanism of action. In the context of previously published results, these effects are durable.

Amorcyte is developing AMR-001, a cell therapy for the treatment of cardiovascular disease, and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving cardiac function and preventing adverse clinical events after a large myocardial infarction.

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, as mentioned above, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its CDMO business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to (i) the Company's ability to manage its business despite operating losses and cash outflows, (ii) its ability to obtain sufficient capital or strategic business arrangement to fund its operations, including the clinical trials for AMR-001, (iii) successful results of the Company's clinical trials of AMR-001 and other cellular therapeutic products that may be pursued, (iv) demand for and market acceptance of AMR-001 or other cell therapies if clinical trials are successful and the Company is permitted to market such products, (v) establishment of a large global market for cellular-based products, (vi) the impact of competitive products and pricing, (vii) the impact of future scientific and medical developments, (viii) the Company's ability to obtain appropriate governmental licenses and approvals and, in general, future actions of regulatory bodies, including the FDA and foreign counterparts, (ix) reimbursement and rebate policies of government agencies and private payers, (x) the Company's ability to protect its intellectual property, (xi) the company's ability to successfully divest its interest in Erye, and (xii) matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem Announces New Publication That Supports Positive Results of AMR-001 for Treatment of AMI