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UC San Diego named stem cell ‘alpha clinic’

PUBLIC RELEASE DATE:

23-Oct-2014

Contact: Scott LaFee slafee@ucsd.edu 619-543-6163 University of California - San Diego @UCSanDiego

In a push to further speed clinical development of emerging stem cell therapies, Sanford Stem Cell Clinical Center at UC San Diego Health System was named today one of three new "alpha clinics" by the California Institute for Regenerative Medicine (CIRM), the state's stem cell agency.

The announcement, made at a public meeting in Los Angeles of the CIRM Governing Board, includes an award of $8 million for each of three sites. The other alpha grant recipients are the City of Hope hospital near Los Angeles and University of California, Los Angeles.

"A UC San Diego alpha clinic will provide vital infrastructure for establishing a comprehensive regenerative medicine clinical hub that can support the unusual complexity of first-in-human stem cell-related clinical trials," said Catriona Jamieson, MD, PhD, associate professor of medicine at UC San Diego School of Medicine, deputy director of the Sanford Stem Cell Clinical Center, director of the UC San Diego Moores Cancer Center stem cell program and the alpha clinic grant's principal investigator.

"The designation is essential in much the same manner that comprehensive cancer center status is an assurance of scientific rigor and clinical quality. It will attract patients, funding agencies and study sponsors to participate in, support and accelerate novel stem cell clinical trials and ancillary studies for a range of arduous diseases."

The alpha clinics are intended to create the long-term, networked infrastructure needed to launch and conduct numerous, extensive clinical trials of stem cell-based drugs and therapies in humans, including some developed by independent California-based investigators and companies. These trials are requisite before any new drug or treatment can be approved for clinical use.

The clinics will also emphasize public education to raise awareness and understanding of stem cell science in part to combat "stem cell tourism" and the marketing of unproven, unregulated and potentially dangerous therapies and help establish sustainable business models for future, approved stem cell treatments.

"Everything we do has one simple goal, to accelerate the development of successful treatments for people in need," said C. Randal Mills, PhD, CIRM president and CEO. "Stem cell therapies are a new way of treating disease; instead of managing symptoms, cellular medicine has the power to replace or regenerate damaged tissues and organs. And so we need to explore new and innovative ways of accelerating clinical research with stem cells. That is what we hope these alpha stem cell clinics will accomplish."

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UC San Diego named stem cell 'alpha clinic'

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Japanese team develops cardiac tissue sheet from human iPS cells

KYOTO A team of Japanese researchers has successfully created cardiac tissue sheets generated from human induced pluripotent stem cells, according to a study in the online British journal Scientific Reports.

The team said it is the first time iPS cells have produced an integrated cardiac tissue sheet that includes vascular cells as well as cardiac muscle cells and is close to real tissue in structure.

The stem cell team, led by Kyoto University professor Jun Yamashita, hopes the achievement will contribute to the development of new treatments for heart disease, because it has already found evidence that transplanting the sheets into mice with failing hearts improves in their cardiac condition.

The team used a protein called VEGF, which is related to the growth of blood vessels, as a replacement for the Dkk1 protein previously used to create cardiac muscle sheets from iPS cells.

As a result, iPS cells were simultaneously differentiated to become cardiac muscle cells, vascular mural cells, and the endothelial cells that line the interior surface of blood vessels. The cells were cultivated into a sheet about 1 cm in diameter.

Three-layer cardiac tissue sheets were then transplanted into nine mice with dead or damaged heart muscle caused by heart attacks. In four of the mice, blood vessels formed in the area where the sheets were transplanted, leading to improved cardiac function.

The weak point of iPS cells is that there is a risk of developing cancer, but the cells did not become cancerous within two months of transplantation, the team said.

About 72 percent of the cardiac tissue sheet was made of cardiac muscle cells, while 26 percent of it consisted of endothelial cells as well as vascular mural cells. But the sheet contained a small portion of cells that had not changed, leading the team to call attention to the possibility that a cancerous change might take place over the longer term.

Yamashita said in the study that he believed the new form of cardiac sheets attached well.

Oxygen and nourishment were able to reach cardiac muscle through blood because there were blood vessels, he said.

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Japanese team develops cardiac tissue sheet from human iPS cells

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Stem Cells Grown From Patient's Arm Used To Replace Retina

BarbaraHudson writes: The Globe and Mail is reporting the success of a procedure to implant a replacement retina grown from cells from the patient's skin. Quoting: "Transplant doctors are stepping gingerly into a new world, one month after a Japanese woman received the first-ever tissue transplant using stem cells that came from her own skin, not an embryo. On Sept. 12, doctors in a Kobe hospital replaced the retina of a 70-year-old woman suffering from macular degeneration, the leading cause of blindness in the developed world. The otherwise routine surgery was radical because scientists had grown the replacement retina in a petri dish, using skin scraped from the patient's arm.

The Japanese woman is fine and her retinal implant remains in place. Researchers around the world are now hoping to test other stem-cell-derived tissues in therapy. Dr. Jeanne Loring from the Scripps Research Institute in La Jolla, Calif., expects to get approval within a few years to see whether neurons derived from stem cells can be used to treat Parkinson's disease."

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Stem Cells Grown From Patient's Arm Used To Replace Retina

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UC San Diego named stem cell 'alpha clinic'

PUBLIC RELEASE DATE:

23-Oct-2014

Contact: Scott LaFee slafee@ucsd.edu 619-543-6163 University of California - San Diego @UCSanDiego

In a push to further speed clinical development of emerging stem cell therapies, Sanford Stem Cell Clinical Center at UC San Diego Health System was named today one of three new "alpha clinics" by the California Institute for Regenerative Medicine (CIRM), the state's stem cell agency.

The announcement, made at a public meeting in Los Angeles of the CIRM Governing Board, includes an award of $8 million for each of three sites. The other alpha grant recipients are the City of Hope hospital near Los Angeles and University of California, Los Angeles.

"A UC San Diego alpha clinic will provide vital infrastructure for establishing a comprehensive regenerative medicine clinical hub that can support the unusual complexity of first-in-human stem cell-related clinical trials," said Catriona Jamieson, MD, PhD, associate professor of medicine at UC San Diego School of Medicine, deputy director of the Sanford Stem Cell Clinical Center, director of the UC San Diego Moores Cancer Center stem cell program and the alpha clinic grant's principal investigator.

"The designation is essential in much the same manner that comprehensive cancer center status is an assurance of scientific rigor and clinical quality. It will attract patients, funding agencies and study sponsors to participate in, support and accelerate novel stem cell clinical trials and ancillary studies for a range of arduous diseases."

The alpha clinics are intended to create the long-term, networked infrastructure needed to launch and conduct numerous, extensive clinical trials of stem cell-based drugs and therapies in humans, including some developed by independent California-based investigators and companies. These trials are requisite before any new drug or treatment can be approved for clinical use.

The clinics will also emphasize public education to raise awareness and understanding of stem cell science in part to combat "stem cell tourism" and the marketing of unproven, unregulated and potentially dangerous therapies and help establish sustainable business models for future, approved stem cell treatments.

"Everything we do has one simple goal, to accelerate the development of successful treatments for people in need," said C. Randal Mills, PhD, CIRM president and CEO. "Stem cell therapies are a new way of treating disease; instead of managing symptoms, cellular medicine has the power to replace or regenerate damaged tissues and organs. And so we need to explore new and innovative ways of accelerating clinical research with stem cells. That is what we hope these alpha stem cell clinics will accomplish."

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UC San Diego named stem cell 'alpha clinic'

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New, faster therapeutic hypothermia techniques

PUBLIC RELEASE DATE:

23-Oct-2014

Contact: Kathryn Ryan kryan@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News @LiebertOnline

New Rochelle, NY, October 23, 2014Rapid lowering of body temperature following an acute myocardial infarction (MI) can be an effective therapeutic strategy to minimize damage to the heart muscle caused by the loss and restoration of blood flow to the heart. While hypothermia shows clinical promise, current methods to cool the heart are insufficient. Faster, more effective techniques are needed to realize the full cardioprotective potential of this emerging intervention, as described in an article in Therapeutic Hypothermia and Temperature Management, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free on the Therapeutic Hypothermia and Temperature Management website at http://online.liebertpub.com/doi/full/10.1089/ther.2014.0016 until November 23, 2014.

In the article "Hypothermia in the Setting of Experimental Acute Myocardial Infarction: A Comprehensive Review", Michael J. Herring and coauthors from Good Samaritan Hospital and Keck School of Medicine, University of Southern California (Los Angeles, CA) and Harbor-UCLA Medical Center (Torrance, CA) examine the benefits and limitations of past and current methods of delivering hypothermia. These include topical regional hypothermia, an open-chest method of cooling the heart; endovascular cooling using a heat exchange balloon catheter to cool the blood that flows through the heart; surface cooling with blankets or convective-immersion therapy; and other methods.

"This timely review on the use of therapeutic hypothermia targeting myocardial necrosis emphasizes the need for additional investigations to maximize the benefits of this experimental therapy in promoting recovery in this patient population," says W. Dalton Dietrich, PhD, Editor-in-Chief of Therapeutic Hypothermia and Temperature Management and Kinetic Concepts Distinguished Chair in Neurosurgery, Professor of Neurological Surgery, Neurology and Cell Biology, University of Miami Leonard M. Miller School of Medicine.

###

About the Journal

Therapeutic Hypothermia and Temperature Management provides a strong multidisciplinary forum covering all aspects of hypothermia and temperature considerations relevant to this exciting field, including its application in cardiac arrest, spinal cord and traumatic brain injury, stroke, and burns. Novel findings from translational preclinical investigations as well as clinical studies and trials are featured in peer-reviewed articles, state-of-the-art review articles, provocative roundtable discussions, clinical protocols, and best practices. Therapeutic Hypothermia and Temperature Management is the journal of record, published online with Open Access options and in print. Tables of content and a sample issue may be viewed on the Therapeutic Hypothermia and Temperature Management website at http://www.liebertpub.com/ther.

About the Publisher

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New, faster therapeutic hypothermia techniques

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Genomics Research Lab Planned For Branford

The Icahn School of Medicine at Mount Sinai is opening a satellite Genetic Testing Lab in Branford, in space formerly occupied by 454 Life Sciences.

The managing director of Mt. Sinai Testing Lab-Connecticut was vice president of research and development at 454, and the director of laboratory operations was the director of the sequencing center at 454.

The Icahn Institute for Genomics and Multiscale Biology announced the move in September, and Gov. Dannel P. Malloy toured the facility Thursday and talked about the government incentives offered to the medical school.

The Department of Economic and Community Development gave it a $9.5 million subsidized loan and, if the institute meets hiring projections and reaches a staff or 142 people over the next five years, $7.25 million of the loan will be forgiven.

454 Life Sciences, the DNA sequencing machine company that had occupied the space, employed about 200 people in 2007, when it was bought by Roche for $155 million. Roche announced a year ago that it would close and lay off 100 employees.

Glenn Farrell, a spokesman for the Icahn genomics institute, said Mt. Sinai has been working for months to renovate the former 454 space and has shipped equipment there. The facility has hired 10 people, and is recruiting for about 10 more, including entry-level technicians, early career technicians, a quality assurance professional, managers and an accessioning specialist. He said it should open in December.

Currently, the Genetic Testing Lab in New York employs about 100 people. The largest part of its work is doing genetic screening for couples planning to have a child. The lab also does more comprehensive screening for patients whose illness is a mystery and cancer target-specific gene testing.

The Institute had 340 employees at the end of last year in New York, including 188 staff, 87 professors and 65 post-doctorate researchers. It has been aggressively expanding in all those areas, and in its 2013 annual report, boasted of recruiting a Yale University professor. Mt. Sinai's medical school is ranked in the top 20 nationally, and its genetics specialty is ranked 15th.

In New York, it is exploring genetic markers in cancer, autism, schizophrenia, colitis and Crohn's disease, congenital heart disease and Alzheimer's.

It outgrew its testing lab space in New York, and Farrell said New York City is a difficult place to find affordable space where you can expand quickly.

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Genomics Research Lab Planned For Branford

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UCSD, other stem cell clinics get millions

UCSD oncologist/researcher Catriona Jamieson is principal investigator for the university's $8 million stem cell grant.

To speed up the quest to bring stem cell therapies to patients, a state agency on Thursday granted $8 million each to three academic medical centers pursuing "translational" work -- UC San Diego, UC Los Angeles and City of Hope in Duarte.

The California Institute for Regenerative Medicine voted 10-1 to fund the "alpha" stem cell clinics, which are intended to bring stem cell treatments to the public.

UC San Diego's proposal supports two stem cell-based clinical trials, both already underway. Catriona Jamieson, an oncologist at the university, is the principal investigator for the grant.

One, a treatment for Type 1 diabetes, was developed by San Diego's ViaCyte. The other, for spinal cord injuries, was developed by Geron of Menlo Park. Geron dropped the trial, but it was picked up by Neuralstem of Germantown, Md. In October, UCSD treated the first patient in the revived trial at the university's Sanford Stem Cell Clinical Center.

The stem cell agency, commonly called CIRM, has focused heavily on basic research since its founding by California voters in 2004. But in recent years, the public has become more anxious to see the fruits of $3 billion in bond money given to the agency reach patients. The "alpha" clinics funded Thursday are part of that effort.

Early optimism that treatments would be quickly available was disappointed, mainly because issues of safety had to be resolved first. Therapies that actually place cells in the body posed new risks, because as living things, cells grow and can migrate. Embryonic stem cells can form tumors. Viacyte and Neuralstem grow replacement tissues from embryonic stem cells, so they needed to show that no unconverted cells would accidentally be introduced into the patient.

Skepticism has also grown over the ethics of CIRM officials, mainly regarding conflicts of interests. Many CIRM board members are chosen from institutions that get funded -- a feature written into the agency by Prop. 71. CIRM has adopted reforms to limit board members from voting in matters where they have conflicts. But CIRM's previous president, Alan Trounson, caused more controversy when he joined the board of CIRM-funded Stemcells Inc, just one week after departing the agency.

CIRM President Randy Mills, who replaced Trounson earlier this year, has tried to quell the controversy with new standards to prevent officials like Trounson from appearing to cash in on their agency role. And he has worked with the governing board to rethink how the agency's remaining funds can be best spent.

CIRM has invested heavily in San Diego stem cell programs, most notably contributing $43 million to a $127 million "collaboratory" building across from the Salk Institute in La Jolla. The Sanford Consortium, as it's called, brings together researchers from five institutions: UCSD, the Salk Institute, The Scripps Research Institute, the Sanford-Burnham Medical Research Institute and the La Jolla Institute for Allergy & Immunology.

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UCSD, other stem cell clinics get millions

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UCLA and UCI Awarded $8M Grant to Launch Collaborative Stem Cell Clinic “Center of Excellence”

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Newswise In a first-of-its-kind collaboration, the University of California, Los Angeles, Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research and University of California, Irvine Sue & Bill Gross Stem Cell Research Center received a five year $8M grant from the California Institute of Regenerative Medicine (CIRM), the states stem cell agency, to establish a CIRM Alpha Stem Cell Clinic center of excellence to conduct clinical trials for investigational stem cell therapies and provide critical resources and expertise in clinical research.

The $8M grant was one of three awarded today by CIRM as part of the CIRM Alpha Stem Cell Clinics (CASC) Network Initiative. The joint UCLA/UCI award under the direction of Dr. John Adams, a member of the UCLA Broad Stem Cell Research Center and professor in the department of orthopaedic surgery, will accelerate the implementation of clinical trials and delivery of stem cell therapies by providing world-class, state-of-the-art infrastructure to support clinical research.

CIRM grant reviewers lauded the UCLA/UCI Consortiums impressive and multidimensional team of experienced personnel that will expand access to patients, attracting national and international clinical trials and accelerating future trials in the pipeline.

The initial stem cell trials supported by the UCLA/UCI Alpha Stem Cell Clinic will be two UCLA projects using blood forming stem cells. The first trial will test a stem cell-based gene therapy for patients with bubble baby disease, also called severe combined immune deficiency (SCID), in which babies are born without an immune system. Under the direction of Dr. Donald Kohn, the clinical trial will use the babys own stem cells with an inserted gene modification to correct the defect and promote the creation of an immune system. The second clinical trial, under the direction of Dr. Antoni Ribas, will use patients own genetically modified blood-forming stem cells to engineer and promote an immune response to melanoma and sarcomas.

This CIRM Alpha Stem Cell Clinic grant is an important acknowledgement of our cutting-edge research and will help us to advance the design, testing and delivery of effective and safe stem cell-based therapies, said Dr. Owen Witte, professor and director of the Broad Stem Cell Research Center. The implementation of a standard of excellence in clinical research will improve healthcare and the lives of patients far beyond the longevity of individual trials.

Operating as part of the larger state-wide CIRM supported network, Alpha Stem Cell Clinics provide critical operational support to conduct clinical trials, with focused resources and expertise in stem cell-based clinical research including clinical operations support and patient care coordination personnel.

UCI has established a strong preclinical stem cell research program, and its vital to move ahead to the clinical testing phase, said Sidney Golub, director of UCIs Sue & Bill Gross Stem Cell Research Center. To advance treatments in this field, we all have to work together, and thats what the UCLA-UCI Alpha Stem Cell Clinic program represents.

About the UCLA Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research

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UCLA and UCI Awarded $8M Grant to Launch Collaborative Stem Cell Clinic "Center of Excellence"

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