Category Archives: Stem Cell Treatment


New details in Grekos patient death case

BONITA SPRINGS -

An attorney for the Bonita Springs doctor accused of performing controversial stem cell treatment on a patient who then died expects depositions to be taken this week that he says will help clear his client's name.

Dr. Zannos Grekos had his medical license suspended back in March after a patient, 77-year-old Richard Poling, died following an injection of his own stem cells.

Documents posted on the Department of Health's website show that Poling paid $8,000 by wire transfer to have his own stem cells removed from his body and sent by courier to a lab in Boynton Beach. The cells were to be processed and returned the same day.

According to the documents, Poling had stomach pains before his cells were returned. Doctors discovered the man had a hematoma, and made him comfortable while he waited for his tissue to be returned for re-injection.

The Department of Health found the laboratory used to process the cells "turned out to be a small office in a strip mall" and "the person that allegedly operated the machine that performed the ultrasonic cavitation on the sample of R.P.'s tissue was unsupervised and was not licensed either by the Florida Board of Medicine or by the Florida Board of Clinical Laboratory Personnel."

Further, documents state the stem cell material was not tested, only visually inspected before being brought back to Bonita Springs.

Poling went into cardiac arrest as the cells were injected into his body.

The Department of Health report states the stem cells were found during autopsy in the pulmonary arteries and capillaries.

Grekos' attorney says the clinician who worked at the Boynton Beach lab did not need a license. He tells NBC2 the clinician and an assistant will be interviewed this week by the Department of Health. Department officials have not confirmed that information.

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New details in Grekos patient death case

Experimental Stem Cell Treatment Tested for Type 1 Diabetes

In Early Study, Procedure Helps Teens Halt Insulin Injections

June 11, 2012 (Philadelphia) -- In an early study, an experimental stem cell procedure helped 15 teens with type 1 diabetes stay off of insulin injections for about 1.5 years, on average.

The study was very small, and the procedure is not ready for widespread use. "We now have a unique approach with some positive findings, but it's still early. We need to better understand the biology behind the treatment and follow patients for long-term side effects," Robert E. Ratner, MD, chief scientific and medical officer of the American Diabetes Association, tells WebMD.

This is the latest of several stem cell studies to show promising results for the treatment of type 1 diabetes, Ratner notes.

In the new study, 15 of 28 teens with type 1 diabetes who got an experimental treatment using their own stem cells went into remission and did not need insulin injections for an average of about 1.5 years.

The "cocktail treatment" combines stem cell therapy with drugs that suppress the body's immune system. In type 1 diabetes, the immune system attacks and destroys insulin-producing cells within the pancreas.

The experimental treatment is called autologous nonmyeloablative hematopoietic stem cell transplantation (HSCT). It aims to kill the destructive immune system cells and replace them with immature stem cells not programmed to destroy insulin-producing cells.

First, patients are given drugs to stimulate production of blood stem cells. The blood stem cells are then removed from the body and frozen. Then, patients are hospitalized and given drugs to kill the destructive immune system cells. The harvested blood stem cells are then put back into the patient.

Eight teens who took part in the study have remained insulin-free for two years, on average. One patient has gone without insulin injections for 3.5 years.

"All our patients considered the [treatment] to be worthwhile and beneficial, though some patients experienced side effects," study head Weiqiong Gu, MD, of Ruijin Hospital in Shanghai, tells WebMD.

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Experimental Stem Cell Treatment Tested for Type 1 Diabetes

ZIOPHARM Oncology Announces Dosing of First Patient in Phase 3 Study of Palifosfamide for the Treatment of Small Cell …

NEW YORK, June 11, 2012 (GLOBE NEWSWIRE) -- ZIOPHARM Oncology, Inc. (ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that the first patient has been dosed in the MATISSE study (Multicenter Adaptive Trial Investigating Small cell lung cancer Survival Endpoints), a pivotal Phase 3 multi-center, open-label, adaptive, randomized study of palifosfamide for the treatment of small cell lung cancer. ZIOPHARM has also recently announced the completion of enrollment in its Phase 3 study of palifosfamide in combination with doxorubicin for the treatment of metastatic soft tissue sarcoma in the front-line setting (PICASSO 3).

The MATISSE study is designed to enroll up to 548 chemotherapy naive patients with extensive-stage small cell lung cancer. Eligible patients will be randomized, one-to-one, to receive either palifosfamide in combination with carboplatin and etoposide (PaCE) or carboplatin and etoposide alone. The trial's primary endpoint is overall survival. Secondary endpoints include progression-free survival, objective response rate and quality of life. MATISSE will be conducted at centers in North America, Europe, Australia and Asia.

"Small cell lung cancer is an extraordinarily difficult to treat cancer, for which there has been no novel treatment in decades," said Lawrence Einhorn, M.D., Distinguished Professor at the Simon Cancer Center of Indiana University Medical Center, Lance Armstrong Foundation Chair in Oncology, former President of ASCO and a member of ZIOPHARM's Medical Advisory Board. "An important element of treating the disease is to find an agent that is safe and has minimal variability between patients. Palifosfamide has demonstrated broad therapeutic activity, including effects against cancer stem cells, as well as good tolerability alone and in combination with various chemotherapeutics. MATISSE incorporates a novel, adaptive study design that should provide a clinically meaningful understanding of palifosfamide's activity and tolerability in advanced disease as quickly as possible for this heavily underserved population."

The study's adaptive design includes a prospectively planned opportunity for modification of the study protocol by adjusting one or more specified components of the design in order to maintain adequate power. Evaluation of the study's powering will be conducted by an Independent Data Monitoring Committee (IDMC) at a single, pre-planned interim analysis, scheduled to occur following 125 events. At the interim analysis, the IDMC will review all efficacy and safety data and decide whether to: 1) halt the study for efficacy or futility, 2) continue the study to its planned enrollment of 548 patients, 3) decrease sample size, or 4) increase event size.

The MATISSE study is designed around clinical data from several studies of palifosfamide, including a Phase 1b, open-label, dose escalation study of intravenous palifosfamide in combination with etoposide and carboplatin in patients with SCLC and other selected cancers, which demonstrated good tolerability and a clinical benefit rate of 67%. Data from a Phase 3 randomized study of ifosfamide, an in-class DNA-targeted anti-cancer therapy, conducted by the Hoosier Oncology Group (HOG) were also incorporated in to the efficacy rationale for the MATISSE study. In this HOG study, ifosfamide demonstrated a survival benefit, the only front-line therapy added to standard of care to do so in SCLC, but was not pursued due to the excessive toxicities.

About Small Cell Lung Cancer

Small cell lung cancer is almost exclusively associated with cigarette smoking, and the majority of patients with extensive disease are treated front-line but relapse with a very high mortality within one year. According to the American Cancer Society, approximately 15 percent of lung cancers are SCLC, or an incidence of approximately 33,400 patients yearly in the U.S. There is expected to be a substantially growing incidence worldwide.

About ZIOPHARM Oncology, Inc.:

ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company's clinical programs include:

Palifosfamide (ZIO-201), a novel DNA-targeted cancer treatment that bypasses drug resistance mediated by ALDH (aldehyde dehydrogenase), an enzyme associated with cancer stem cells, and has a favorable toxicity profile. Intravenous palifosfamide is currently being studied in a randomized, double-blinded, placebo-controlled Phase 3 trial (PICASSO 3) for the treatment of front-line metastatic soft tissue sarcoma and is also in a pivotal Phase 3 trial (MATISSE) for front-line metastatic small cell lung cancer. Additionally, the Company is developing an oral capsule form of palifosfamide.

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ZIOPHARM Oncology Announces Dosing of First Patient in Phase 3 Study of Palifosfamide for the Treatment of Small Cell ...

Research and Markets: Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics

DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/pqrlwc/analysis_of_the_st) has announced the addition of Frost & Sullivan's new report "Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics" to their offering.

Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics

This Frost & Sullivan research service titled Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics focuses on prospects for the stem cell therapeutics market in Europe and provides valuable recommendations and conclusions for market participants. Market segmentation is based on regulatory framework in Europe relating to research on adult and embryonic stem cells. The main countries discussed are the United Kingdom, Germany, France, Spain, Sweden, Finland, and the remaining parts of Europe.

Market Overview

New Applications in Drug Discovery Platforms to Drive Stem Cells Market

Stem cells offer exciting potential in regenerative medicine, and are likely to be widely used by mid-2017. Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research. The market will be driven by stem cell applications in drug discovery platforms and by successful academia -commercial company partnership models.

The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase, notes the analyst of this research. Previously, animal cell lines, tumours, or genetic transformation have been the traditional platform for testing drug candidates; however, these abnormal' cells have significantly contributed to a lack of translation into clinical studies. Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research. This will provide impetus to the emergence of novel cell-based therapies.

Host of Challenges Need to be Confronted before Stem Cell Therapeutics can Realise its Potential

Key challenges to market development relate to reimbursement, ethics and the complexity of clinical trials. Securing reimbursement for stem cell therapeutic products is expected to be critical for commercial success. However, stem cell therapies are likely to be expensive. Insurers, therefore, may be unwilling to pay for the treatment. At the same time, patients are unlikely to be able to afford these treatments. The use of embryonic stem cells raises a host of thorny ethical, legal, and social issues, adds the analyst. As a result, market prices for various products may be affected. Moreover, many research institutes are adopting policies promoting the ethical use of human embryonic tissues. Such policies are hindering the overall research process for several companies working in collaboration with these institutes.

In addition to apprehensions about how many products will actually make it through human-based clinical trials, companies are also worried about which financial model can be applied to stem cell therapies, cautions the analyst. Possibly low return on investment (ROI) is also resulting in pharmaceutical companies adopting a cautious approach to stem cell therapeutics. To push through policy or regulatory reforms, the technology platform and geographical location of stem cell companies should complement the terms laid down in EMEA. The methodology for cell expansion and synchronisation must be optimised to acquire a large population of the desired cell at the right differentiation point, adds the analyst. More research is needed in human pluripotent and multi potent stem cell as it differs from mice to humans. Completion of clinical trials will be essential to ensure the safety and efficacy of the stem cell therapy.

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Research and Markets: Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics

Cytomedix Announces Multiple Poster Presentations at the 44th Annual Conference of the Wound Ostomy Continence Nurses …

GAITHERSBURG, MD--(Marketwire -06/08/12)- Cytomedix, Inc. (CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that four poster presentations highlighting the clinical merits of the Company's AutoloGel System in wound management will be presented at the 44th Annual Conference of the Wound Ostomy and Continence Nurses Society ("WOCN") being held in Charlotte, North Carolina from June 9-13, 2012.

The AutoloGel System, a device for the production of autologous platelet rich plasma ("PRP") gel, is the only PRP device cleared by the U.S. Food and Drug Administration ("FDA") for use in wound management.

The following posters highlighting Cytomedix's PRP technology will be presented at WOCN 2012:

"This body of clinical data demonstrates AutoloGel's ability to accelerate wound healing in common wound etiologies and also shows its effectiveness on fistulas, pseudostomas, and pressure ulcers in persons with spinal cord injury, which are all notoriously difficult to heal wounds. In addition, the data shows that AutoloGel saves money while increasing healing rates and decreasing staff time," commented Carelyn P. Fylling, RN, MSN, CWS, CLNC, Cytomedix's Vice President of Professional Services.

"We are pleased to have these four posters presented at WOCN as it offers an ideal venue to reach and educate a large audience of clinicians who specialize in wound management on the clinical merits of AutoloGel to heal these challenging wounds. These data, collectively and individually, demonstrate the clinical utility of AutoloGel to heal a variety of hard-to-heal wounds," commented Martin P. Rosendale, Chief Executive Officer of Cytomedix. "Compelling clinical results such as these should favorably impact the adoption of AutoloGel in a variety of wounds and wound care settings, and further strengthen final negotiations with our potential top 20 global pharmaceutical partner."

The posters will be available at WOCN as follows:

Sunday, June 10 6:30 am - 8:00 pm Poster Viewing

Monday, June 11 9:00 am - 5:30 pm Poster Viewing

Tuesday, June 12 7:00 am - 9:00 am Authors Session and Awards Presentation 9:00 am - 6:30 pm Poster Viewing

Wednesday, June 13 8:00 am - 12:00 pm Poster Viewing

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Cytomedix Announces Multiple Poster Presentations at the 44th Annual Conference of the Wound Ostomy Continence Nurses ...

Stem cell therapy offers new treatment options for pets — and humans

Select a Publication: N E W S P A P E R S ---------------------------------------------- ---Alberta--- Airdrie - Airdrie Echo Banff - Banff Crag and Canyon Beaumont - Beaumont News Calgary - The Calgary Sun Camrose - Camrose Canadian Canmore - Canmore Leader Central Alberta - County Market Cochrane - Cochrane Times Cold Lake - Cold Lake Sun Crowsnest Pass - Crowsnest Pass Promoter Devon - Dispatch News Drayton - Drayton Valley Western Review Edmonton - Edmonton Examiner Edmonton - The Edmonton Sun Edson - Edson Leader Fairview - Fairview Post Fort McMurray - Fort McMurray Today Fort Saskatchewan - Fort Saskatchewan Record Grande Prairie - Daily Herald Tribune Hanna - Hanna Herald High River - High River Times Hinton - Hinton Parklander Lacombe - Lacombe Globe Leduc - Leduc Representative Lloydminster - Meridian Booster Mayerthorpe - Mayerthorpe Freelancer Nanton - Nanton News Peace Country - Peace Country Sun Peace River - Peace River Record Gazette Pincher Creek - Pincher Creek Echo Sherwood Park - Sherwood Park News Spruce Grove - Spruce Grove Examiner Stony Plain - Stony Plain Reporter Strathmore - Strathmore Standard Vermilion - Vermilion Standard Vulcan - Vulcan Advocate Wetaskiwin - Wetaskiwin Times Whitecourt - Whitecourt Star ---Manitoba--- Altona - Alton Red River Valley Echo Beausejour - Beausejour Review Carman - Carman Valley Leader Gimli - Interlake Spectator Lac Du Bonnet - Lac Du Bonnet Leader Morden - Morden Times Portage la Prairie - Portage Daily Graphic Selkirk - Selkirk Journal Stonewall - Stonewall Argus and Teulon Times Winkler - Winkler Times Winnipeg - The Winnipeg Sun ---Ontario--- Amherstburg - Amherstburg Echo Bancroft - Bancroft this Week Barrie - Barrie Examiner Barry's Bay - Barry's Bay this Week Belleville - Intelligencer Bradford - Bradford Times Brantford - Expositor Brockville - The Recorder & Times Chatham - Chatham Daily News Chatham - Chatham This Week Chatham - Today's Farmer Clinton - Clinton News-Record Cobourg - Northumberland Today Cochrane - Cochrane Times Post Collingwood - Enterprise Bulletin Cornwall - Standard Freeholder Delhi - Delhi News-Record Dresden - Leader Spirit Dunnville - Dunnville Chronicle Elliot Lake - Standard Espanola - Mid-North Monitor Fort Erie - Times Gananoque - Gananoque Reporter Goderich - Goderich Signal-Star Grand Bend - Lakeshore Advance Haliburton - Haliburton Echo Hanover - The Post Ingersoll - Ingersoll Times Innisfil - Innisfil Examiner Kapuskasing - Kapuskasing Northern Times Kenora - Kenora Daily Miner and News Kenora - Lake of the Woods Enterprise Kincardine - Kincardine News Kingston - Frontenac This Week Kingston - Kingston This Week Kingston - Kingston Whig Standard Kirkland Lake - Northern News Leamington - Leamington Post Lindsay - The Lindsay Post London - The London Free Press London - The Londoner Lucknow - Lucknow Sentinel Midland - Free Press Minden - Minden Times Mitchell - Mitchell Advocate Napanee - Napanee Guide Niagara-on-the-Lake - Niagara Advance Niagara Falls - Review Niagara Falls - Niagara Shopping News Niagara Falls - W. Niagara Community Newspapers North Bay - North Bay Nugget Northumberland - Northumberland Today Norwich - Norwich Gazette Orillia - Packet and Times Ottawa - The Ottawa Sun Owen Sound - Sun Times Oxford - Oxford Review Paris - Paris Star Online Pelham - Pelham News Pembroke - Daily Observer Peterborough - Peterborough Examiner Petrolia - Petrolia Topic Picton - County Weekly News Port Colborne - Inport News Port Hope - Northumberland Today Port Elgin - Shoreline Beacon Sarnia - Observer Sarnia - Sarnia This Week Sault Ste Marie - Sault Star Sault Ste Marie - Sault This Week Seaforth - Seaforth Huron Expositor Simcoe - Simcoe Reformer St. Catharines - St. Catharines Shopping News St. Catharines - Standard St. Thomas - St. Thomas Times-Journal Stirling - Community Press Stratford - The Beacon Herald Strathroy - Strathroy Age Dispatch Sudbury - Sudbury Star Thorold - Thorold News Tillsonburg - Tillsonburg News Timmins - Daily Press Timmins - Timmins Times Toronto - The Toronto Sun Trenton - Trentonian Wallaceburg - Wallaceburg Courier Press Welland - Tribune Welland - Welland News West Lorne - The Chronicle Wiarton - Wiarton Echo Woodstock - Sentinel Review ---Saskatchewan--- Meadow Lake - Meadow Lake Progress Melfort - Melfort Journal Nipawin - Nipawin Journal MAGAZINES & SPECIALTY PUBLICATIONS --------- Biz Magazine Business London Cottage Home and Property Showcase Food and Wine Show Hamilton Halton Weddings Hamilton Magazine InterVin International Wine Awards Kingston Life London Citylife Muskoka Magazine Muskoka Trails Niagara Food and Wine Expo Niagara Magazine Ontario Farmer Ontario Golf Sault Good Life Simcoe Life The Home Show Vines Magazine What's Up Muskoka

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Stem cell therapy offers new treatment options for pets -- and humans

Cellular Dynamics Launches MyCell™ Services

MADISON, Wis., June 7, 2012 /PRNewswire/ --Cellular Dynamics International, Inc. (CDI), the world's largest commercial producer of human induced pluripotent stem (iPS) cell lines and tissue cells, today announced the launch of its MyCell Services. These services include novel iPS cell line reprogramming, genetic engineering and differentiation of iPS cells into commercially available iCell terminal tissue cells (for example, heart or nerve cells).

"CDI's mission is to be the top developer and manufacturer of standardized human cells in high quantity, quality and purity and to make these cells widely available to the research community. Our MyCell Services provide researchers with unprecedented access to the full diversity of human cellular biology," said Bob Palay, CDI Chief Executive Officer. "The launch of MyCell Services furthers CDI founder and stem cell pioneer Jamie Thomson's vision to enable scientists worldwide to easily access the power of iPSC technology, thus driving breakthroughs in human health."

Over the past 2 years, CDI has launched iCell Cardiomyocytes, iCell Neurons and iCell Endothelial Cells for human biology and drug discovery research. MyCell Services leverage CDI's prior investment in building an industrial manufacturing platform that can handle the parallel production of multiple iPSC lines and tissue cells, manufacturing billions of cells daily.

Chris Parker, CDI Chief Commercial Officer, commented, "Not all studies requiring human cells can be accomplished by using cells from a limited set of normal, healthy donors. Researchers may need iPS cells or tissue cells derived from specific ethnic or disease populations, and MyCell Services enable them to take advantage of our deep stem cell expertise and robust industrial manufacturing pipeline to do so. Previously, scientists had to create and differentiate iPS cells themselves. Such activities consume significant laboratory time and resources, both of which could be better applied to conducting experiments that help us better understand human biology. CDI's MyCell Services enable scientists to re-direct those resources back to their experiments."

CDI pioneered the technique to create iPS cells from small amounts of peripheral blood, although iPS cells can be created from other tissue types as well. Additionally, CDI's episomal reprogramming method is "footprint-free," meaning no foreign DNA is integrated into the genome of the reprogrammed cells, alleviating safety concerns over the possible use of iPS cells in therapeutic settings. These techniques have been optimized for manufacture of over 2 billion human iPS cells a day, and differentiated cells at commercial scale with high quality and purity to match the research needs.

Modeling Genetic Diversity

CDI has several projects already underway using MyCell Services to model genetic diversity of human biology. The Medical College of Wisconsin and CDI received a $6.3M research grant from the National Heart, Lung, and Blood Institute (NHLBI), announced July 2011, for which CDI's MyCell Services will reprogram an unprecedented 250 iPS cell lines from blood samples collected from Caucasian and African-American families in the Hypertension Genetic Epidemiology Network (HyperGEN) study. In addition, MyCell Services will differentiate these iPS cells into heart cells to investigate the genetic mechanisms underlying Left Ventricular Hypertrophy, an increase of the size and weight of the heart that is a major risk factor for heart disease and heart failure.

Researchers are also using CDI's MyCell Services to generate iPS cells and liver cells from individuals with drug induced liver injury (DILI), toward an eventual goal of identifying genetic factors linked to idiosyncratic liver toxicity. "The most problematic adverse drug event is sudden and severe liver toxicity that may occur in less than one in one thousand patients treated with a new drug, and thus may not become evident until the drug is marketed. This type of liver toxicity is not predicted well by usual preclinical testing, including screening in liver cultures derived from random human donors," said Paul B. Watkins, M.D., director of with The Hamner - University of North Carolina Institute for Drug Safety Sciences. "The ability to use iPS cell technology to prepare liver cultures from patients who have actually experienced drug-induced liver injury, and for whom we have extensive genetic information, represents a potential revolution in understanding and predicting this liability."

Screening Human Disease

While most diseases are multi-systemic, focus typically centers on only one organ system. For example, congenital muscular dystrophy (CMD) is a group of rare genetic diseases with a focus on skeletal muscle, yet other systems, including heart, eye, brain, diaphragm and skin, can be involved. Understanding the molecular mechanisms underlying complex disease phenotypes requires access to multiple tissue types from a single patient. While some systems are readily accessible for taking a biopsy sample, for example skin, other organs are not.

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Cellular Dynamics Launches MyCell™ Services

Stem cells may be to blame for clogged arteries

A newly discovered type of stem cell may be one of the major driving forces behind heart attacks and other killer vascular diseases, according to a new study. The finding may provide a brand new target for future heart disease treatments, the researchers said.

While doctors have long thought that it was the smooth muscle cells within the blood vessel walls that combined with cholesterol and fat to clog the arteries--and developed treatments accordingly--the new research indicates the guilty party may actually be a previously unknown type of stem cell, called a multipotent vascular stem cell.

In a study conducted in mice, researchers found it was these stem cells, rather than muscle cells, that formed the scar tissue that blocks the flow of blood in the arteries and causes them to harden.

According to the researchers, because multipotent stem cells are capable of becoming multiple types of cells, including smooth muscle, nerve, cartilage, bone and fat cells, the ability of the stem cells to form bone or cartilage could explain how a soft artery calcifies and hardens.

We are very confident that vascular stem cells play a much more important role than what was thought previously, principal investigator Dr. Song Li, professor of bioengineering and researcher at the Berkeley Stem Cell Center, told FoxNews.com.

Li said these stem cells appear to be involved in most major vascular diseases such as atherosclerosis and restenosis, or the clogging of the arteries. The researchers also believe the stem cells are involved the repair and diseases of all blood vessels.

The study could potentially lead to an entirely new area of heart disease treatment, as there are no therapies or medications that currently target stem cells.

Previous therapies focused on cholesterol metabolism and killing smooth muscle cells, Li said. This new finding opens a door to new therapies that target the vascular stem cells, not only to block the proliferation of the stem cells but also stop their differentiation into bone, cartilage, and even fat cellsIt will be a new area for vascular biology, medicine and the pharmaceutical industry.

However, Li said it was important to note the stem cells arent all bad they appear to not only be involved with disease development but also in the regeneration of blood vessels after certain surgeries, such as bypass procedures.

The stem cells can do good and bad things, and the fate needs to be controlled after we understand the mechanisms, Li said.

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Stem cells may be to blame for clogged arteries

Haematopoietic stem cell transplantation increases survival in systemic sclerosis patients

Public release date: 7-Jun-2012 [ | E-mail | Share ]

Contact: Candice Debleu eularpressoffice@cohnwolfe.com 44-789-438-6425 European League Against Rheumatism

Berlin, Germany, June 7 2012: Initial results from an international, investigator-initiated, open label phase III trial were presented at EULAR 2012, the Annual Congress of the European League Against Rheumatism. Data indicate that haematopoietic stem cell transplantation (HSCT) results in better long term survival than conventional treatment for patients with poor prognosis early diffuse cutaneous systemic sclerosis.

The ASTIS (Autologous Stem Cell Transplantation International Scleroderma) trial enrolled more than 150 patients between 2001 and 2009, and randomised patients to the HSCT arm or to intravenous pulse cyclophosphamide treatment. As of May 1, 2012, significantly more deaths have occurred in the conventional treatment group. Half of the deaths in the HSCT group occurred early and were deemed treatment-related according to an independent data monitoring committee. In the conventional treatment group in contrast, none of the deaths were deemed to be treatment-related; but more deaths occurred later and most were related to progressive disease.

"Systemic sclerosis is a debilitating disease that can lead to heart, lung or kidney failure and premature death, especially in patients who have the diffuse cutaneous form of the condition, where skin thickening is more generalised and involvement of vital organs more common. The ASTIS study shows that such patients may benefit from early intensive immunosuppressive treatment," said Professor Jaap van Laar from Newcastle University, Professor Dominique Farge, Assistance Publique Hopitaux de Paris (Sponsor in France, Paris 7 University) and Professor Alan Tyndall from Basel University, on behalf of their colleagues from the EBMT EULAR Scleroderma Study Group. "These initial results are very encouraging and will help identify patients who benefit from stem cell transplantation."

The ASTIS trial was a unique collaborative project of 27 multidisciplinary teams from 10 countries conducted under the auspices of two leading organisations in the respective fields, the European Group for Blood and Marrow Transplantation (EBMT; http://www.ebmt.org) and the European League Against Rheumatism (EULAR;www.eular.org). The primary endpoint of the trial was event-free survival, defined as survival until death or development of major organ failure.

Systemic sclerosis is a rare but severe autoimmune systemic connective tissue disease*. Increased fibroblast activity results in abnormal growth of connective tissue which causes vascular damage and fibrosis of the skin, gastrointestinal (GI) tract and other internal organs**. Characteristics of systemic sclerosis include vasomotor disturbances; fibrosis; subsequent atrophy of the skin, subcutaneous tissue, muscles, and internal organs and immunologic disturbances*. Systemic sclerosis is estimated to occur in 2.3-10 people per one million*. Diffuse cutaneous systemic sclerosis cases make up 30% of all systemic sclerosis cases and involve the upper arms, thighs and trunk**. Lung fibrosis and pulmonary hypertension are important causes of mortality in these patients and there is no curative treatment available so far*.

###

Abstract Number: LB0002

*Schwartz R A. (2011) Medscape Reference: Systemic Sclerosis. [Online] Available from: http://emedicine.medscape.com/article/1066280-overview [Accessed 8 May 2012]

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Haematopoietic stem cell transplantation increases survival in systemic sclerosis patients

Neil Riordan PhD – Stem Cell Therapy for Spinal Cord Injury (Part 3 of 5) || Stem Cell Treatments – Video

06-06-2012 13:09 Mesenchymal stem cell homing to tissue damage, umbilical cord stem cells historically used for anti-aging, mesenchymal stem cells role in immune system modulation, inflammation reduction and stimulating tissue regeneration, donor stem cell safety and testing, the role of HLA matching in donated umbilical cord-derived stem cells, umbilical cord blood safety data and historical use in blood transfusions, allogeneic stem cell persistence in human mothers. Treatment information at More information on Dr. Riordan at

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Neil Riordan PhD - Stem Cell Therapy for Spinal Cord Injury (Part 3 of 5) || Stem Cell Treatments - Video