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Thread: Embryonic stem cells trial on track to start

  1. #1

    Embryonic stem cells trial on track to start

    I cannnot wait for this to see this.

    Wednesday May 9, 12:00 PM
    Embryonic stem cells trial on track to start

    By Clive Cookson in Boston

    The first clinical trial of embryonic stem cells is on track to start early next year on patients with spinal cord injury. Geron (GERN - news) , the California-based biotechnology company, will carry out the study on accident victims in six trauma centres across the US

    "The world's spotlight will be on this trial," Tom Okarma, Geron's chief executive, told the Bio conference in Boston. To get it right, the company has carried out several years of preparatory work in collaboration with its academic partners at the University of California, Irvine.

    Geron's product will have been tested in 2,000 animals before it goes into its first patient, Mr Okarma said. It consists of immature oligodendrocytes – specialised nerve cells – grown from human embryonic stem cells. The animal tests show that these can repair spinal cord injuries in rats, by growing new nerves with the myelin sheaths they need to work properly. Paralysed rats can walk again.

    Mr Okarma said the product was designed to repair recent spinal damage and would need to be injected into patients within two weeks of the accident. It could not help people with long-term paralysis such as the late actor Christopher Reeve who did so much to champion stem cell research for spinal injury.

    Because the first application for a human embryonic stem cell trial is bound to receive extraordinary scrutiny from the US Food and Drug Administration, Geron is working closely with FDA officials to smooth the path in advance of the submission. The embryonic stem cells are already qualified for human therapeutic use, after exhaustive tests showed that the cell cultures contain no contamination with animal proteins or viruses.

    Mr Okarma pointed out that human embryonic stem cell research was less than 10 years old; the first such cells were produced at the University of Wisconsin in 1998. "With breakthrough therapies such as antibodies and genetic engineering there is usually a 10 to 20 year period of government funding academic research that improves upon the basic invention before industry can put its toes in," he said.

    Last edited by manouli; 05-09-2007 at 10:51 AM.

  2. #2
    Analysis: Stem cells closer to trials

    UPI Senior Medical Correspondent
    WASHINGTON, May 9 (UPI) -- Despite the limitations on federal funding for embryonic stem cell research, two companies recently said they are close to entering clinical trials with the versatile cells.
    Geron plans to file an investigational new drug application with the Food and Drug Administration by the end of the year for using cells derived from embryonic stem cells for treating spinal injuries.

    Advanced Cell Technology, which previously said it planned to file an IND this year for using stem cell-derived therapies for treating macular degeneration, announced this week it has developed a technique to generate a type of progenitor cell that could move into the clinic in 2008 for treating a variety of ills.

    Robert Lanza, Advanced Cell's vice president of medical and scientific affairs, told United Press International that the cells -- called hemangioblasts that his group derived from human embryonic stem cells -- have proven their ability to repair vascular damage in the eyes and limbs of animals. This indicates the cells could prove beneficial for treating heart attacks, reversing vascular damage that now requires limbs to be amputated, and other conditions.

    "We're planning to file with the FDA next year to use them in patients," Lanza said.

    Advanced Cell's technique is described in the online issue of Nature Methods. Although it's still in the early days, he said the hemangioblasts also could be used to create immune tolerance so the body does not reject the cells as foreign.

    "This would allow us to transplant any type of replacement cell or organ generated from a specific stem cell line without rejection," Lanza said. "It would make therapeutic cloning unnecessary and obviate the need for millions of human eggs."


  3. #3
    Man, I hope there are no hiccups in getting these trials underway.
    No one ever became unsuccessful by helping others out

  4. #4

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