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San Francisco, CA, United States

The California Institute for Regenerative Medicine was created in 2004 after 59% of California voters approved California Proposition 71 that governs the allocation of the $3 billion authorized to fund stem cell research in California. The agency was authorized to distribute the money in grants, funded by bonds, over a ten-year period to institutions and scientists throughout California that focused on advancing stem cell research and regenerative medicine. The mission of CIRM is: To support and advance stem cell research and regenerative medicine under the highest ethical and medical standards for the discovery and development of cures, therapies, diagnostics and research technologies to relieve human suffering from chronic disease injury. Wikipedia.

Doyle R.,California Institute for Regenerative Medicine
Annals of the American Thoracic Society | Year: 2016

Considerable progress has been made toward developing targeted biological therapeutics for asthma, due in large part to a deeper understanding of asthma pathophysiology. This explosion of knowledge has revealed asthma to be a much more complex and heterogeneous entity than previously understood. The identification of particular asthma phenotypes with distinct pathophysiologic mechanisms has opened up a new era for patient populations not well served by current therapies, especially patients with severe asthma. Copyright © 2016 by the American Thoracic Society. Source

Kadereit S.,University of Konstanz | Trounson A.,California Institute for Regenerative Medicine
Seminars in Immunopathology | Year: 2011

The observation that embryonic stem cells (ESCs) expressed reduced levels of major histocompatibility (MHC) class I genes, no MHC class II or costimulatory molecules suggested early on that pluripotent stem cells (PSCs) could be "immune-privileged" and were unable to induce immune reactions. However, soon it became apparent that in some instances, ESCs were recognized by immune cells but still could reduce an active and strong immune response. Similar results were obtained with other PSCs. Almost 10 years later, the exact mechanisms are still not well understood and seem to differ between the different human and rodent PSC lines (even between different murine cell lines). These differences could be due to differing experimental approaches, different derivation protocols (to obtain the PSC lines), species specificity, or genetic background of the cells lines. A better understanding of the immune regulatory mechanisms deployed by PSCs and early derivates may inform us on immune regulation and could be exploitable for regenerative medicine using allogeneic cells. As PSCs grow robustly in culture and can easily be gene-modified, one could envision the generation of cell lines that maintain these immune suppressive properties through terminal differentiation, thus generating universal donor cells. © 2011 Springer-Verlag. Source

Knoepfler P.S.,University of California at Davis | Knoepfler P.S.,California Institute for Regenerative Medicine
Advanced Drug Delivery Reviews | Year: 2015

The phrase "bench-to-bedside" is commonly used to describe the translation of basic discoveries such as those on stem cells to the clinic for therapeutic use in human patients. However, there is a key intermediate step in between the bench and the bedside involving governmental regulatory oversight such as by the Food and Drug Administration (FDA) in the United States (US). Thus, it might be more accurate in most cases to describe the stem cell biological drug development process in this way: from bench to FDA to bedside. The intermediate development and regulatory stage for stem cell-based biological drugs is a multifactorial, continually evolving part of the process of developing a biological drug such as a stem cell-based regenerative medicine product. In some situations, stem cell-related products may not be classified as biological drugs in which case the FDA plays a relatively minor role. However, this middle stage is generally a major element of the process and is often colloquially referred to in an ominous way as "The Valley of Death". This moniker seems appropriate because it is at this point, and in particular in the work that ensues after Phase 1, clinical trials that most drug product development is terminated, often due to lack of funding, diseases being refractory to treatment, or regulatory issues. Not surprisingly, workarounds to deal with or entirely avoid this difficult stage of the process are evolving both inside and outside the domains of official regulatory authorities. In some cases these efforts involve the FDA invoking new mechanisms of accelerating the bench to beside process, but in other cases these new pathways bypass the FDA in part or entirely. Together these rapidly changing stem cell product development and regulatory pathways raise many scientific, ethical, and medical questions. These emerging trends and their potential consequences are reviewed here. © 2014 Elsevier B.V. Source

Dimmeler S.,Goethe University Frankfurt | Ding S.,University of California at San Francisco | Rando T.A.,Stanford University | Trounson A.,California Institute for Regenerative Medicine
Nature Medicine | Year: 2014

The scientific community is currently witnessing substantial strides in understanding stem cell biology in humans; however, major disappointments in translating this knowledge into medical therapies are flooding the field as well. Despite these setbacks, investigators are determined to better understand the caveats of regeneration, so that major pathways of repair and regrowth can be exploited in treating aged and diseased tissues. Last year, in an effort to contribute to this burgeoning field, Nature Medicine, in collaboration with the Volkswagen Foundation, organized a meeting with a panel of experts in regenerative medicine to identify the most pressing challenges, as well as the crucial strategies and stem cell concepts that can best help advance the translational regenerative field. Here some experts who participated in the meeting provide an outlook at some of those key issues and concepts. © 2014 Nature America, Inc. Source

Martell K.,Biotechnology Consultant | Trounson A.,California Institute for Regenerative Medicine | Baum E.,California Institute for Regenerative Medicine
Cell Stem Cell | Year: 2010

A workshop addressing regulation of clinical implementation of stem cell therapies preceded the ISSCR 8th Annual Meeting, cosponsored by the International Society for Stem Cell Research, the California Institute for Regenerative Medicine and the International Society for Cellular Therapy. © 2010 Elsevier Inc. Source

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