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Thread: Second spinal cord injury patient in stem cell trial

  1. #1

    Second spinal cord injury patient in stem cell trial

    Second spinal cord injury patient in stem cell trial


    By Julie Steenhuysen

    CHICAGO | Tue May 10, 2011 5:25pm EDT

    CHICAGO (Reuters) - Doctors have begun treating a second patient injected with human embryonic stem cells in the spine as part of a landmark Geron Corp clinical trial testing the cells in spinal cord injuries.

    The patient, who is not being identified, will undergo a progressive course of rehabilitation at the Rehabilitation Institute of Chicago after receiving an injection of stem cells at Northwestern Memorial Hospital, Northwestern officials said Tuesday.

    "We are very excited to announce the second enrollment in this milestone study, which is the first to evaluate the effects of cells derived from embryonic stem cells in subjects with severe spinal cord injuries," Dr. Richard Fessler, who is leading the study, said in a statement.



    http://www.reuters.com/article/2011/...74970X20110510

  2. #2
    This is good news. It was worrisome that no patients were done for over six months after the first patient was done at Shepherd in Atlanta last October.

    Wise.

    Quote Originally Posted by manouli View Post
    Second spinal cord injury patient in stem cell trial


    By Julie Steenhuysen

    CHICAGO | Tue May 10, 2011 5:25pm EDT

    CHICAGO (Reuters) - Doctors have begun treating a second patient injected with human embryonic stem cells in the spine as part of a landmark Geron Corp clinical trial testing the cells in spinal cord injuries.

    The patient, who is not being identified, will undergo a progressive course of rehabilitation at the Rehabilitation Institute of Chicago after receiving an injection of stem cells at Northwestern Memorial Hospital, Northwestern officials said Tuesday.

    "We are very excited to announce the second enrollment in this milestone study, which is the first to evaluate the effects of cells derived from embryonic stem cells in subjects with severe spinal cord injuries," Dr. Richard Fessler, who is leading the study, said in a statement.



    http://www.reuters.com/article/2011/...74970X20110510

  3. #3
    Senior Member mj23's Avatar
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    I live in Chicago and saw a report on this it this morning. They said they injected a small dose of stem cells in the patient. They said if they see good enough results then they will increase the amount of stem cells injected into a patient and if they see good enough results then they'll move from there.
    C-5, 6 SCI. Took about 6 months to walk. Walking full time. Without any assistance since Nov. 2003 and will make a full recovery

  4. #4
    Senior Member mj23's Avatar
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    Chicago has 2nd patient in landmark embryonic stem cell trial

    Geron Corp. trial also has patient in Atlanta

    Researchers from Northwestern Memorial Hospital and the Rehabilitation Institute of Chicago have enrolled a spinal-cord injury patient in a closely watched clinical trial using embryonic stem cells in humans.

    The patient, an individual injured in a recent car crash, becomes only the second patient to receive embryonic stem cells as part of a study designed largely to test the safety of the treatment derived from such cells developed by Geron Corp. in patients with new spinal-cord injuries. The study is the first trial of its kind approved last year by the U.S. Food and Drug Administration to use embryonic stem cells in humans.

    Researchers would not disclose the name of the patient, who was paralyzed from the chest down in the last two weeks and cannot walk. The patient received an injection of 50 microliters, or about two drops, of the special oligodendrocyte progenitor cells into his spine. Larger dosages are expected to be used in future studies after safety has been established.

    "The participant received an injection of cells over the weekend at Northwestern Memorial and will now undergo a progressive course of rehabilitation care and intervention at the Rehabilitation Institute of Chicago," Dr. Richard Fessler, lead national investigator of Geron's trial and a neurosurgeon at Northwestern Memorial, said Tuesday.

    The patient's dosage likely is too small to restore any limb function. Still, the enrollment of a second patient is considered significant. Just 10 patients at six sites across the country are expected to take part in the first phase of the trial. Atlanta's Shepherd Center said last year that it had the first patient in the trial.

    Any treatment that emerges from the study could be a decade away from broader use in patients. A drug or therapy typically takes five to 10 years to wend its way through clinical trials and the FDA approval process.

    "It remains too early in the trial to determine improvement in neuromuscular control or sensation," Fessler said.

    Stem cells are building blocks that theoretically can be manipulated to perform the work of other cell types. Stem cells from days-old embryos are being hailed because they hold the promise to produce any type of cell in the body, but opponents maintain it's wrong to use cells from a destroyed embryo.

    A decade ago, the administration of President George W. Bush limited federal funding for research to certain embryonic cell lines. President Barack Obama has since lifted restrictions and approved more lines that can qualify for federal funding.

    Fessler said the privately funded trial by Geron, based in Menlo Park, Calif., falls under the original stem cell lines approved by President George H.W. Bush in the 1980s and is open to use in federally funded research projects. The Geron trial uses stem cells from embryos that would have been "discarded anyway," he said.

    Analysts say political controversies have kept many researchers on the sidelines and put early hopes for an embryonic treatment in the hands of researchers such as those at Northwestern University.

    "Restoring a patient's ability is our objective, and the scientific application of embryonic stem cells offers exciting new hope for recovery," said Dr. David Chen, medical director of the Rehabilitation Institute's Spinal Cord Injury Rehabilitation Program.

    Some researchers and pharmaceutical companies also have said they see more promise using adult stem cells. Other trials using adult-derived stem cells are under way, though such a product has yet to be approved by the FDA.

    Deerfield-based Baxter International Inc., for example, is working with another Northwestern researcher, Dr. Douglas Losordo, on a clinical trial of elderly patients who have adult stem cells injected into damaged hearts in hopes of regenerating them. That study is being conducted at dozens of hospitals across the U.S.

    from the Chicago Tribune
    http://www.chicagotribune.com/busine...,6510994.story

    (On a side note, Dr. David Chen was my rehab doctor when I was at RIC in 2002. Great doctor.)
    Last edited by mj23; 05-12-2011 at 05:56 PM.
    C-5, 6 SCI. Took about 6 months to walk. Walking full time. Without any assistance since Nov. 2003 and will make a full recovery

  5. #5
    Very freaking interesting

  6. #6
    Senior Member Stormycoon's Avatar
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    VERY.. ESPECIALLY THE 10 YEARS AWAY
    I am not your rolling wheels
    I am the highway
    I am not your carpet ride
    I am the sky
    I am not your blowing wind
    I am the lightning
    I am not your autumn moon
    I am the night, the night..

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    Senior Member mj23's Avatar
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    Somethings better then nothing imo

    Quote Originally Posted by Stormycoon View Post
    VERY.. ESPECIALLY THE 10 YEARS AWAY
    C-5, 6 SCI. Took about 6 months to walk. Walking full time. Without any assistance since Nov. 2003 and will make a full recovery

  8. #8
    Quote Originally Posted by Wise Young View Post
    This is good news. It was worrisome that no patients were done for over six months after the first patient was done at Shepherd in Atlanta last October.

    Wise.
    There is dialogue between Geron and the FDA about whether all the inclusion/exclusion criteria and required to do this trail safely. At the current enrollment rate it will take 5 years to enroll the first ten patients then likely 18 months from the date the last patient is treated until this rolls to phase two.

  9. #9
    I hope the negotiations go well with the FDA. They were wanting several things changed to speed the trial up. They'd wanted to begin including T12 injuries and lessen the 30 day time frame between patients. I believe they were adding two more sites and extending the perimeter so more patients could be included. I think their initial safety protocols had them tied down too tightly. Lets hope the FDA is agreeable to the changes.

  10. #10
    Good news, but they need to go a little bit faster with the enrollments, or this trial will last for ever
    -Ramps in buildings are necessary, but it would be usefull to have another ones for people (mind/heart).....

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