The SAGE Encyclopedia of Stem Cell Research. Группа авторов

      California Stem Cell, Inc.

      California Stem Cell, Inc.

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      California Stem Cell, Inc.

      A private company, California Stem Cell, Inc. (CSC) was established in Irvine, California, in 2005 for the purpose of developing therapies using stem cells, particularly those directed at treating various forms of cancer and neurological disorders. The focus of CSC’s work is on developing human embryonic stem cells (hESCs) that have the ability to develop into other cells (pluripotency). These cells are then dispatched all over the world for use in stem cell research and therapies. The company was established as a direct result of the passage of California’s Proposition 71, which passed in November 2004 in the face of restrictions that President George W. Bush had placed on federal funding for stem cell research. Backed by Hollywood elite that included actors Michael J. Fox, who suffers from Parkinson’s disease, and Christopher Reeve, who was paralyzed during a horseback riding accident, Proposition 71 made stem cell research a constitutional right and allotted $300 million annually for stem cell research over a 10-year period.

      CSC’s work has led the company to patent therapies for generating human stem cell lines that have been expanded and differentiated at high purity for use in treating spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS), spinal cord injuries, and coronary heart disease. The company has generated a platform method for treating cancer that has major implications for an eventual cure. The process involves removing cancer cells from a tumor, growing them and purifying them in a laboratory, injecting them with patient-specific immune stem cells, and finally returning them to the patient. Because the method has already been proved successful, obtaining Food and Drug Administration (FDA) approval for new clinical trials moves much more rapidly when testing treatments for other cancers. Within three years of its founding, CSC had obtained private financing to expand both its laboratories and its manufacturing capabilities. CSC continues to remain financially stable even when some other stem cell companies have been forced to cease work on certain therapies for lack of funding.

      The Experts

      Dr. Hans S. Keirstead is the president and chief executive officer of CSC. He also serves as the chair of the company’s Scientific Advisory Board. Keirstead took a leave of absence from his position as a professor of neurobiology at the University of California, Irvine to join CSC. He is an internationally recognized expert in stem cell research, specializing in regeneration, degeneration, spinal cord injury, myelin, demyelination, axon growth core, and plasticity. Canadian-born, Keirstead was educated at the University of British Columbia and did postdoctoral work at the University of Cambridge in the United Kingdom.

      Keirstead came to California in 2000 to work for the Reeve-Irvine Research Center at the University of California, Irvine. By that time, he had become known as the leader of the team that discovered the first successful stem cell therapy for treating paralyzed rats. The team developed a 42-day protocol in which they were able to observe development inside a rat embryo, discovering that embryonic stem cells were like a blank canvas waiting to form into organs and other cells. The team was then able to use that knowledge to develop stem cell treatments for restoring some motor function to paralyzed rats. It was not until the findings were replicated by four independent laboratories in different parts of the world that the discovery was declared a breakthrough in the development of stem cell research. Ultimately, this success has had major implications for treating spinal cord injury in humans. Keirstead also conducted clinical trials on stem cell therapies for ulcerative colitis and rheumatoid arthritis and developed a 3D retina using stem cell therapy. Keirstead was one of the authors of California’s Proposition 71, which allotted $3 billion in state funds for stem cell research in 2004. He also testified before Congress and the California state legislature in support of stem cell research.

      Working closely with Keirstead, Dr. Chris N. Airriess serves California Stem Cell, Inc. as chief development officer. Airriess specializes in biomedicine and informational technology. He completed postdoctoral work at the Laboratory of Molecular Signaling at Cambridge University in the United Kingdom and the University of Sydney in Australia before taking a position at the University of British Columbia, where he remained until he left to become CDO of CSC.

      The Research

      During its first decade of existence, California Stem Cell, Inc. concentrated major resources on treating cancers with patient-specific immunotherapies. CSC worked with Hoag Memorial Hospital on creating a therapy that could immunize a patient against cancer stem cells by using radiation to kill cancer cells and then injecting the cleansed cells with immunized cells. During three separate clinical trials, the recurrence rate of cancers was significantly reduced. One of those trials involved patients with metastatic melanoma, a deadly form of skin cancer. The phase II trials produced a survival rate of 54%, double the normal survival rate for this cancer. The potential impact of such therapies is particularly important for patients with cancers involving the liver, ovaries, and breasts and for those with gliobastoma and non-small-cell lung cancer. California Stem Cell, Inc. and the University of California, Irvine, used a $4.5 million grant from the California Institute for Regenerative Medicine (CIRM) to transplant 3D retinal tissue in patients with vision problems.

      In 2014, phase III clinical trials designated as Special Protocol Assessment and Fast Track were begun on patients with metastatic melanomas. In February 2014, CSC received FDA approval to begin phase II trials using patient-specific stem cell therapies to treat

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