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Thread: UPMC clinical trial

  1. #1
    Senior Member PC720's Avatar
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    UPMC clinical trial

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    UPMC?s clinical trial showing promise with spinal cord injuries

    February 26, 2016 12:00 AM
    By David Templeton / Pittsburgh Post-Gazette













    [COLOR=#00A85B !important][/COLOR]


    Three years ago, Michael Fraser broke his neck in a diving accident near his Vandergrift home but remembers little about it.
    But in April, the man with quadriplegia underwent an experimental neural stem-cell procedure that wasn?t only a life-changing experience but could represent the first interventional treatment for spinal cord injuries.
    Mr. Fraser, 24, now can lift himself from his wheelchair into bed without assistance. He breathes more freely and deeply and has greater core strength with better dexterity. Previously he could manage only a half-mile on his arm-powered elliptical but now does two to three miles, he said.


    His condition so vastly improved that the Robert Morris University graduate who previously couldn?t work plans to move to Atlanta with his brother, Cori Fraser, and become an insurance actuary. ?Honestly, whenever I signed up for the [UPMC clinical] trial, I kept myself in check and did not expect something crazy,? he said. ?But this definitely has exceeded my expectations.?
    PG graphic: Spinal-injury treatment
    (Click image for larger version)


    Hope now is on the horizon for those with traumatic spinal cord injuries that the neural stem-cell treatment can restore some motor and sensory function. If ongoing clinical trials confirm early results and lead to U.S. Food and Drug Administration approval, it could represent the long-awaited therapeutic treatment for people with paraplegia and quadriplegia.
    Two early phase trials showed promise. With a Phase II trial now underway, StemCells Inc. of Newark, Calif., is recruiting patients in Pittsburgh and nationwide who have cervical (neck area) spinal cord injuries resulting in full paralysis of the legs and at least partial paralysis of the arms.
    The company is seeking 40 total participants, including a baseline group, with one-third already on board.
    Describing the project as ?medically and scientifically important,? Stephen I. Huhn, the neurosurgeon serving as StemCells Inc.?s vice president of clinical research and chief medical officer, said the randomized, blinded trial will test more definitely whether the surgical stem-cell procedure succeeds in restoring function and sensation in patients.
    ?As challenging as spinal cord injury is and given how difficult it is to treat, this is a very powerful place to be,? he said. ?We never have been able to offer a therapeutic intervention to restore function in people, and we may be able to do that. It?s exciting and that?s the advance we?re trying to make.?
    Last May, StemCells Inc., a biotech company whose stock is traded on NASDAQ, said seven of 12 patients with thoracic spinal cord injuries who underwent the stem cell procedure experienced new sensations inches below the injury level in middle of the back. The focus was establishing safe stem-cell dosage levels, but it also produced beneficial results.
    Another Phase I trial that concluded in July involved six patients with cervical spinal cord injuries resulting in quadriplegia, including Mr. Fraser at UPMC. Five of the six patients, each on a different stem-cell dose, showed improved upper-body strength while four of six also developed better dexterity six months after the surgery, Dr. Huhn said.

    It?s ?tremendously exciting? to work on a new phase in spinal cord injury medicine, said Michael C. Munin, a University of Pittsburgh School of Medicine professor in the department of physical medicine and rehabilitation and principal investigator for the Pittsburgh trial. He and Dr. Huhn explained the process.
    Neural stem cells from fetuses are acquired through a nonprofit organization that collects tissue after elective abortions; the patients sign release forms donating the tissue. In StemCell Inc.?s laboratories, the cells proliferate in a culture. During a delicate surgical procedure, thousands of the cells are injected near or on the spinal cord above and below the damage site.

    Exactly how the stem cells work isn?t fully understood, Dr. Munin said, but they possibly receive signals from existing spinal cord cells that cause their transformation into neurons ? the key nerve cells in the spinal cord and brain ? and supportive ?glial? cells that coat the nerves with myelin among other functions to protect and enhance nerve function.

    Studies using rabbits showed that the stem cells create a bridge around the damage site while likely producing chemicals necessary for their survival and proliferation. Adding to the optimism is what Mr. Fraser is experiencing: Functional improvements are continuing with time.

    Since his accident, Mr. Fraser said, he has maintained a positive attitude through an amazing family-support system.

    But his results from the stem-cell procedure, he said, have been nothing short of incredible: ?You can pray every night, but when you see improvements in a year like I have, it?s just a blessing,? he said.
    Those interested in joining the trial should call 412-692-2084.

    David Templeton: dtempleton@post-gazette.com or 412-263-1578.




    Last edited by SCI-Nurse; 02-26-2016 at 09:08 AM.

  2. #2
    Thanks for the article post PC720. The article doesn't specifically say it, but my understanding is that they have 13 trial sites located across the U.S. Interesting article.

  3. #3
    Senior Member marvin_cr's Avatar
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    While Dr. Wise waits for the some "mythical" publication of his work, others doing UMB work will pass him by. If you don't want others to pass you by, you need to get something in the publics eye, even if it's just teaser.

  4. #4
    Quote Originally Posted by marvin_cr View Post
    While Dr. Wise waits for the some "mythical" publication of his work, others doing UMB work will pass him by. If you don't want others to pass you by, you need to get something in the publics eye, even if it's just teaser.
    Hi Marvin! I don't know if there is anyone else doing umbilical cord cell trials.
    Both StemCells Inc. and Neuralstem are different aged "neural stem cells".
    There's a few other small trials using other various cell types for sure.

    Here is a list of trials ongoing and some listed as completed at this LINK if anyone is interested.
    Last edited by GRAMMY; 02-26-2016 at 01:52 PM.

  5. #5
    Senior Member Moe's Avatar
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    UPMC?s clinical trial showing promise with spinal cord injuries

    February 26, 2016 12:00 AM
    By David Templeton / Pittsburgh Post-Gazette

    Three years ago, Michael Fraser broke his neck in a diving accident near his Vandergrift home but remembers little about it.
    But in April, the man with quadriplegia underwent an experimental neural stem-cell procedure that wasn?t only a life-changing experience but could represent the first interventional treatment for spinal cord injuries.

    Mr. Fraser, 24, now can lift himself from his wheelchair into bed without assistance. He breathes more freely and deeply and has greater core strength with better dexterity. Previously he could manage only a half-mile on his arm-powered elliptical but now does two to three miles, he said.

    His condition so vastly improved that the Robert Morris University graduate who previously couldn?t work plans to move to Atlanta with his brother, Cori Fraser, and become an insurance actuary. ?Honestly, whenever I signed up for the [UPMC clinical] trial, I kept myself in check and did not expect something crazy,? he said. ?But this definitely has exceeded my expectations.?

    Hope now is on the horizon for those with traumatic spinal cord injuries that the neural stem-cell treatment can restore some motor and sensory function. If ongoing clinical trials confirm early results and lead to U.S. Food and Drug Administration approval, it could represent the long-awaited therapeutic treatment for people with paraplegia and quadriplegia.
    Two early phase trials showed promise. With a Phase II trial now underway, StemCells Inc. of Newark, Calif., is recruiting patients in Pittsburgh and nationwide who have cervical (neck area) spinal cord injuries resulting in full paralysis of the legs and at least partial paralysis of the arms.
    The company is seeking 40 total participants, including a baseline group, with one-third already on board.

    Describing the project as ?medically and scientifically important,? Stephen I. Huhn, the neurosurgeon serving as StemCells Inc.?s vice president of clinical research and chief medical officer, said the randomized, blinded trial will test more definitely whether the surgical stem-cell procedure succeeds in restoring function and sensation in patients.
    ?As challenging as spinal cord injury is and given how difficult it is to treat, this is a very powerful place to be,? he said. ?We never have been able to offer a therapeutic intervention to restore function in people, and we may be able to do that. It?s exciting and that?s the advance we?re trying to make.?

    Last May, StemCells Inc., a biotech company whose stock is traded on NASDAQ, said seven of 12 patients with thoracic spinal cord injuries who underwent the stem cell procedure experienced new sensations inches below the injury level in middle of the back. The focus was establishing safe stem-cell dosage levels, but it also produced beneficial results.
    Another Phase I trial that concluded in July involved six patients with cervical spinal cord injuries resulting in quadriplegia, including Mr. Fraser at UPMC. Five of the six patients, each on a different stem-cell dose, showed improved upper-body strength while four of six also developed better dexterity six months after the surgery, Dr. Huhn said.

    It?s ?tremendously exciting? to work on a new phase in spinal cord injury medicine, said Michael C. Munin, a University of Pittsburgh School of Medicine professor in the department of physical medicine and rehabilitation and principal investigator for the Pittsburgh trial. He and Dr. Huhn explained the process.
    Neural stem cells from fetuses are acquired through a nonprofit organization that collects tissue after elective abortions; the patients sign release forms donating the tissue. In StemCell Inc.?s laboratories, the cells proliferate in a culture. During a delicate surgical procedure, thousands of the cells are injected near or on the spinal cord above and below the damage site.
    Exactly how the stem cells work isn?t fully understood, Dr. Munin said, but they possibly receive signals from existing spinal cord cells that cause their transformation into neurons ? the key nerve cells in the spinal cord and brain ? and supportive ?glial? cells that coat the nerves with myelin among other functions to protect and enhance nerve function.

    Studies using rabbits showed that the stem cells create a bridge around the damage site while likely producing chemicals necessary for their survival and proliferation. Adding to the optimism is what Mr. Fraser is experiencing: Functional improvements are continuing with time.
    Since his accident, Mr. Fraser said, he has maintained a positive attitude through ?an amazing family-support system.?
    But his results from the stem-cell procedure, he said, have been nothing short of incredible: ?You can pray every night, but when you see improvements in a year like I have, it?s just a blessing,? he said.

    Those interested in joining the trial should call 412-692-2084.

    David Templeton: dtempleton@post-gazette.com or 412-263-1578

    SOURCE

  6. #6
    Where from can we get a few more details about this patient, like his previous level and AIS, and what's the change?

  7. #7
    Are treating completes, but I don't know how this is considered a potential treatment for Pratik's considering they won't let anyone participate in the trial that's been injured longer than two years. Everyone knows after two years unfortunately recovery even from experimental therapy's is much more unlikely, that is what's told to us at lease
    Last edited by JamesMcM; 03-01-2016 at 05:32 PM.

  8. #8
    No one has ever recovered. Two years is as good a guess as two centuries.

  9. #9
    Actually that is false, I talked to someone named Doug Smith Who injured himself in professional hockey! he damaged the spinal cord of the C5 vertebrae, and was paralyzed from the neck down for a short period of time. Soon after surgery he regains the movement of of his toe and according to him he continued to work that connection relentlessly until he slowly started regaining more and more function. As that happened he continued to work harder with the more he regained. after around two or three years, I believe he was nearly fully recovered. Meaning anyone untrained would never know he had an accident, other than himself of course... he says there still problems. There's One other guy that's been mentioned on here too, I wouldnt consider them chronic recoveries but they begin their "battle of recovery" within the two-year mark



    As it stands for myself, I know for a fact I could've recovered more if I've worked harder right after the injury! Sadly I was a very severe injury and A high one, so I couldn't do much of anything on my own... but more importantly the hospital that I went to had no kind of exercise equipment for someone of my limited movement! Such as the lokomats little brother the Erigo, Which can be started very early in acute care. If you were lucky enough to be admitted in the hospital that had one I believe they try and get spinal injury patients in them five times a week. But I was provided with nothing but a 20 minute stretch couple times a week, that will lift your spirit! So I was left with simple visualizations As my only form of exercise and "just trying to move" ( which like anything I could've always worked harder at), which I believe can play a role, Especially in the incomplete injuries. But only go so far on its own... After six months functional recovery from rehabilitation exercises alone becomes less likely ( nearly impossible if you haven't been doing any kind of real stimulation for those six months ), a year even more so , Two years almost impossible as I am now approaching my fourth year 100% undoubtedly correctly diagnosed complete not a chance in hell! It's all about preventing the steady rotting and decay now...
    Last edited by JamesMcM; 03-01-2016 at 05:51 PM.

  10. #10
    At 2 1/2 years out I am still trying to get that toe to move. If that damn toe moves I'm off to the races! I have busted my ass trying to recover. I think it's a bit much to think that if you do the right exercises at the acute stage you will recover. I agree that exercise will affect the rate and maybe the extent but ultimately minimally. It's biology.

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