Welcome to our first edition of Stem Cell News. Our aim is to keep you
informed about the latest developments across the stem cell field
including recent highlights in research, clinical translation and
relevant policy and regulations.
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STEM CELL RESEARCH NEWS
PUBLICATIONS
INDUSTRY NEWS
POLICY & REGULATIONS NEWS
Stem Cell Research News
REPROGRAMMING
Reprogramming of adult cells back to a pluripotent stem cell – referred to as an induced pluripotent stem (iPS) cell - has been one of the most significant advances of the past ten years. First published in 2006 using adult mouse cells, this technology was quickly applied to human stem cells.
Initially reprogramming was achieved through inserting four genes, one a known cancer causing gene, into the adult cells using a retrovirus. However, iPS cell technology is advancing swiftly and a recent paper in Nature reports that differentiated human cells have been reprogrammed to an embryonic like state with the addition of only one gene, rather than the standard four. Read more:
Kim, J.B. Direct reprogramming of human neural stem cells by OCT4. Nature advance online publication, doi:10.1038/nature08436 (28 August 2009) with commentary from The Niche Stem Cell Blog.
In late breaking news, a team at the Harvard Stem Cell Institute led by Kevin Eggan have published online in Cell Stem Cell (subscription required) that they have made an made an advance toward producing iPS cells, that are safe enough to use in treating diseases in patients by replacing two of the traditional reprogramming genes with a chemical. Read more.
For his pioneering work in the reprogramming field, Professor Shinya Yamanaka of Kyoto University, the first to publish mouse iPS cells has recently been awarded a prestigious Lasker Award, known as the ‘American Nobel Prize’ for accomplishments in medical research. He was jointly awarded the prize with John Gurdon for discoveries concerning nuclear reprogramming, the process that instructs specialised adult cells to form early stem cells — creating the potential to become any type of mature cell for experimental or therapeutic purposes. Read more.
OUTCOMES FROM THE 2009 ISSCR MEETING, BARCELONA
In July 2009 the International Society for Stem Cell Research (ISSCR), the world's largest stem cell organisation, held its annual meeting in Barcelona. Over 3000 attendees participated. An overview of the publications associated with this meeting can be found by clicking here.
CORNEAL STEM CELLS RESTORE SIGHT
In May 2009, University of New South Wales (UNSW) medical researchers reported that they had used stem cells cultured on a simple contact lens to restore sight to sufferers of blinding corneal disease. The breakthrough was published in the journal Transplantation.
The research team from UNSW's School of Medical Sciences harvested stem cells from patients' own eyes to rehabilitate the damaged cornea. The stem cells were cultured on a common therapeutic contact lens which was then placed onto the damaged cornea for 10 days, during which the cells were able to re-colonise the damaged eye surface.
The researchers were featured in a recent episode of the ABC's New Inventors, to view the footage online, click here. For more information visit the UNSW website.
ASCC CONGRATULATES NOBEL PRIZE WINNER DR ELIZABETH BLACKBURN
The ASCC congratulates USA based Australian scientist Dr Elizabeth Blackburn for winning the 2009 Nobel Prize in Physiology or Medicine. Dr Blackman received the award for the discovery of how chromosomes are protected by telomeres and the enzyme telomerase. She was awarded the Nobel Prize along with long-time US collaborators Jack Szostak and Carol Greider. Read more.
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Recent Key Publications from Australian Stem Cell Researchers
Stem cell researchers from across Australia (including those funded and not funded by the ASCC) continue to make significant contributions to the field in diverse areas. Below is a selection of recent key publications.
Aberrant luminal progenitors as the candidate target population for basal tumor development in BRCA1 mutation carriers. Lim E, Vaillant F, Wu D, Forrest NC, Pal B, Hart AH, Asselin-Labat ML, Gyorki DE, Ward T, Partanen A, Feleppa F, Huschtscha LI, Thorne HJ; k ConFab, Fox SB, Yan M, French JD, Brown MA, Smyth GK, Visvader JE, Lindeman GJ.
Nat Med. 2009 Aug;15(8):907-13. Epub 2009 Aug 2.
Thrombin cleaved Osteopontin regulates hemopoietic stem and progenitor cell functions through interactions with a9B1 and a4B1 integrins. Grassinger J, Haylock DN, Storan M, Haines GO, Williams B, Whitty G, Vinson A, Be CL, Li S, Sorensen E, Tam PL, Denhardt DT, Sheppard D, Choong PF, Nilsson SK.
Blood 2009: 114(1): 49-59
VEGF-mediated cross-talk within the neonatal murine thymus. Cuddihy AR, Ge S, Zhu J, Jang J, Chidgey A, Thurston G, Boyd R, Crooks GM.
Blood 2009: 113:2723-31
Paneth cell development in the small intestine is CSF-1 dependent. Ramsay R, Huynh D, Dai X, Nandi S, Lightowler S, Trivett M, Chan C, Bertoncello I, Stanley ER
Gastroenterology 2009 [In press]
Colony Stimulating Factor 1 Dependence of Paneth Cell Development in the Mouse Small Intestine. Huynh D, Dai X, Nandi S, Lightowler S, Trivett M, Chan C, Bertoncello I, Ramsay R, Stanley ER
Gastroenterology 2009: 137(1):136-144
ErythRED, a human embryonic stem cell line enabling unambiguous identification of globin expressing cells in vitro and in vivo. Hatzistavrou T, Micallef S, Stanley EG, Elefanty AG.
Nature Methods 2009; 6, 659 - 662
Tiny non-coding RNAs are associated with transcription start sites in vertebrates. Taft RJ, Glazov EA, Cloonan N, Simons C, Stephen S, Grimmond SM, Suzuki H, Garninci P, Hayashizaki Y, Mattick JS.
Nature Genetics 2009:41(5)572-8
A Contact Lens-Based Technique for Expansion and Transplantation of Autologous Epithelial Progenitors for Ocular Surface Reconstruction. Di Girolamo, Nick; Bosch, Martina; Zamora, Katherine; Coroneo, Minas T.; Wakefield, Denis; Watson, Stephanie L.
Transplantation, 2009; 87 (10): 1571
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MESOBLAST – SPINAL FUSION, DEGENERATIVE DISC DISEASE, CONGESTIVE HEART FAILURE
Australian company Mesoblast (ASX: MSB) has been making significant progress with its allogeneic stem cell products. In August Mesoblast received US Food & Drug Administration (FDA) clearance for a Phase II clinical trial of NeoFuse™ in minimally invasive lumbar spinal fusion surgery.
In September Mesoblast's adult stem cells demonstrated success in treating degenerative disc disease in a preclinical trial in sheep. A single injection of allogeneic cells reversed disc degeneration, regrew disc cartilage and induced sustained normalisation of disc structure and height. This development may provide a non-invasive treatment approach for back pain caused by disc degeneration.
Mesoblast also completed recruitment for the second group of 20 patients receiving an increased dose of Revascor™ for the treatment of congestive heart failure.
For more information about these developments, click here.
OSIRIS THERAPEUTICS – GRAFT VERSUS HOST DISEASE
Osiris Therapeutics’ Prochymal, which consists of cultured mesenchymal stem cells, failed to demonstrate efficacy in a late stage clinical trial for treating graft-versus-host disease (GvHD). Prochymal performed no better than placebo in the trial. GvHD is a potentially fatal complication of bone marrow transplants in which immune cells from the donated marrow attack the recipient.
While this trial failure can be seen as a major setback to stem cell research, two important facts should be noted. Firstly, the trial failed due to efficacy – not safety. The safety profile of Prochymal was uncompromised. Secondly, the failure rate of drugs in late stage clinical trials is quite high, regardless of whether stem cells are involved or not. Read more (subscription only) or at www.osiristx.com.
GERON – SPINAL CORD INJURY
In January 2009, Geron Corporation (Nasdaq: GERN) won FDA approval for the first clinical trials of a product derived from human embryonic stem cells. Geron’s product, intended to acute treat spinal cord injury, is derived from embryonic stem cells that have been differentiated into precursors of neuron-support cells.
However in August the company announced that the trial had been placed on clinical hold by the FDA pending the agency's review of new animal study data submitted by the company. No patients have yet been treated in this study.
The animal study showed a higher frequency of cysts, although their characteristics were similar to the cysts seen in previous studies: non-proliferative, confined to the injury site, smaller than the injury cavity and not associated with adverse clinical outcomes. These data have been submitted to the FDA and Geron hopes to proceed with the clinical trial in due course, subject to the FDA's approval.
For more information please see www.geron.com.
NEURALSTEM – LOU GEHRIG’S DISEASE/AMYOTROPHIC LATERAL SCLEROSIS
NeuralStem won FDA approval to test its spinal cord stem cells in 12 patients with amyotrophic lateral sclerosis. This trial was previously placed on hold by the FDA in February. NeuralStem’s product is made of cultured neural stem cells derived from a single eight-week fetus.
This trial, expected to take place at Emory University in Atlanta, Georgia will assess safety rather than efficacy.
Read more on The Niche Stem Cell Blog and Neuralstem Inc.
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Policy and Regulation News
NIH ISSUE FINAL GUIDELINES FOR HUMAN STEM CELL RESEARCH
On 7 July, 2009 the National Institutes of Health (NIH) released their final guidelines for Human Stem Cell Research. The guidelines were open to public comment from 23 April 2009 to 26 May 2009. The NIH received approximately 49,000 comments from patient advocacy groups, scientists and scientific societies, academic institutions, medical organisations, religious organisations, private citizens, and members of Congress. The full guidelines and justification can be found here.
LAUNCH OF THE STEM CELL CHARTER
On 22 September 2009, the Canadian Stem Cell Foundation launched The Stem Cell Charter at the World Stem Cell Summit in Baltimore. The Charter sets out five universal principles under which stem cell research should be advanced - the protection of patient rights, transparency, integrity, academic freedom and responsible science.
In an interview, lead author of the charter, Bartha Knoppers, a bioethicist at McGill University described the Stem Cell Charter as a ‘collective call to action in support of stem cell research and a web-based, interactive document detailing how that science should be advanced. The charter lays out a code of conduct for stem cell researchers aimed at promoting science that is carried out in a responsible, ethical way while protecting people from harm and safeguarding the public trust.’
For more information and to sign the Charter clck here.
CIRM ANNOUNCES TWO NEW COLLABORATORS - GERMANY AND MARYLAND
In June 2008, the California Institute for Regenerative Medicine (CIRM), and the State Government of Victoria announced an international collaboration on stem cell research. In May 2009, four collaborative stem cell projects involving researchers from the Australian Stem Cell Centre, Monash University and the Florey Neuroscience Institutes were the first to be funded under this international alliance. All four recipients have been subsequently funded within the Australian Stem Cell Centre’s Collaborative Streams.
Following on from this successful initiative the Victorian Minister for Innovation, Gavin Jennings has recently announced a further $2 million for collaborative projects to investigate stem cell transplantation immunology which is aimed at ensuring human immune tolerance of stem cell derived cell and tissue grafts, such as skin, bone and organ tissue. Read more.
CIRM recently signed two new collaborations. The first with the German Federal Ministry of Education and Research (BMBF) and the second with Maryland Technology Development Corporation (TEDCO).
In both collaborations CIRM, the German ministry and the Maryland Technology Development Corporation are laying the foundation for joint research projects to advance stem cell therapies for treatment of some of today’s most debilitating diseases. This brings the total list of CIRMs partners to seven with Canada, Japan, Spain and the United Kingdom also on the list.
For more information, click here.
UNREGULATED STEM CELL THERAPIES
There have recently been a number of articles published concerning unregulated stem cell therapies, often referred to as ‘stem cell tourism’. This is a complex and difficult area for stem cell scientists as the direct marketing of therapies to consumers via the internet has made it increasingly difficult to assess the merits or otherwise of a particular therapy. In response last December, the ISSCR released the Guidelines for the Clinical Translation of Stem Cells, in which it openly ‘condemns the administration of unproven uses of stem cells or their derivatives to a large series of patients outside of a clinical trial’. The Guidelines and accompanying Patient Handbook on Stem Cell Therapies can be found on the ISSCR website.
More recently, the ISSCR named a Task Force on Unproven Stem Cell Therapies with a charge to develop a policy statement leading, for patients' benefit, to a listing of asserted stem cell therapies that are, to the knowledge of the society, unsupported by published scientific studies, and a listing of individuals, clinics or other entities practicing unproven stem cell therapies. The primary purpose is to develop a website that will be a resource for patients, advocacy groups, clinicians, and associations in evaluating claims of benefit from unproven stem cell therapies. This is expected to include a list of clinics and programs that come to the attention of the ISSCR that provide an unproven stem cell treatment. The task force will not list proven therapies, and therefore does not act as a review body. It is chaired by Patrick Taylor, JD, Children’s Hospital Boston. Relevant groups will be asked to interact with the task force in the generation of the report. www.isscr.org.
In a detailed article entitled Trading on Hope (subscription required) written by Jane Qiu for Nature Biotechnology, a number of these companies and the countries in which they operate are discussed. The author details commercial operations in China, India, Thailand and their links in many cases to the USA. The regulatory framework in these countries is also discussed and outlines the 'mixed messages' that seem to beset this area.
Another article entitled The Rocky Road to Regulation authored by Doug Sipp of the RIKEN Center for Developmental Biology, Kobe, Japan was published in Nature Reports Stem Cells. This article discusses the difficulties in regulating stem cell clinics across the globe and examines reasons why a number of countries have attempted to curtain the provision of unproven therapies and how they have gone about it.
In a development that should be applauded, the Chinese Ministry of Health tightened regulations on stem cell therapies in May 2009. Chinese institutions have been forbidden from commercialising stem cell treatments without first proving that they work through proper clinical trials. The guidelines state that approval for stem cell treatments must be gained from the health ministry. Read more.
STEM CELL AWARENESS DAY – 23 SEPTEMBER 2009
Stem Cell Awareness Day is a public education initiative linking scientists, clinicians, patients and the general public around the world. The Australian celebration was marked by Monash University hosting a webcast linking international stem cell scientists with video seminars which addressed a wide range of topics related to stem cell science and clinical advances. To view the discussions and lectures, which will be available until the end of October, please see www.stemcellawarenessday.com.
Messages in support of Stem Cell Awareness Day, including a statement from Professor Alan Trounson of the California Institute of Regenerative Medicine and proclamations from Governor Arnold Schwarzenegger of California, Governor Jim Doyle of Wisconsin, Mayor Gavin Newsom of San Francisco and Mayor Jerry Sanders of San Diego can be found on www.stemcellday.com.
Please forward enquiries or questions to info@stemcellcentre.edu.au.
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ARC Future Fellowships Awarded to ASCC Research Module Leaders
Two ASCC Module Leaders, A/Professor Susie Nilsson and A/Professor David Haylock, have been awarded the prestigious Australian Research Council Future Fellowships.
What do baby cows and stem cells have in common?
It seems that there have been certain claims made recently suggesting that bovine colostrum enhances stem cell proliferation and therefore cures, or at least alleviates your ills.
Ausbiotech 2009
AusBiotech 2009 is the premier biotechnology conference for the Asia Pacific region.
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