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Thread: Geron's GRNOPC1 2010 Phase I Update (Now Asterias's AST-OPC1)

  1. #1
    Senior Member Moe's Avatar
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    Geron's GRNOPC1 2010 Phase I Update (Now Asterias's AST-OPC1)

    As some may know Asteria took over Geron's 2010 PI trial... disappointing results I may say, what y'all think?

    Read:

    http://asteriasbiotherapeutics.com/o...al-focus/opc1/

    "Results from First-in-Man Clinical Trial of AST-OPC1 in Spinal Cord Inury

    In a Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. The subjects received low levels immunosuppression for the next 60 days.
    Delivery of AST-OPC1 was successful in all five subjects with no serious adverse events associated with the administration of the cells, with AST-OPC1 itself, or the immunosuppressive regimen.
    Immune monitoring of subjects through one year post-transplantation showed no evidence of antibody-based or cellular immune responses to AST-OPC1
    In four of the five subjects, serial MRI scans indicated that reduced spinal cord cavitation may have occurred."

    "There were no unexpected neurological degenerations or improvements."

    Ok... just re-read the last one... Gotta love these confusing double-negative sentences... so were there neurological degenerations or improvements, or not??

    I assume that they meant this:
    -There was no neurological degeneration to the Spinal Cord. (non was predicted)
    -No neurological improvements were detected through the whole Phase 1 trial.
    Last edited by Moe; 05-25-2014 at 06:59 PM.

  2. #2
    Senior Member lunasicc42's Avatar
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    I don't think any neurological improvements are really expected in a phase 1 trial anyway ...but this doesn't affect me anyway ...
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  3. #3
    Quote Originally Posted by lunasicc42 View Post
    I don't think any neurological improvements are really expected in a phase 1 trial anyway ...but this doesn't affect me anyway ...
    There were originally only 2 million cells injected. The numbers will rise this time in the quest for a theraputic dose.

  4. #4
    Quote Originally Posted by c473s View Post
    There were originally only 2 million cells injected. The numbers will rise this time in the quest for a theraputic dose.
    You're right c473s. The agency approved the next trial phase based on the results of a five-patient Phase 1 trial who had neurologically complete thoracic spinal cord injury. Each patient in that trial only received a very low dose of 2 Million AST-OPC1 cells and have been followed for two to three years. The next phase of the trial will have 10X that much administered now that safety has been good so far upon follow-up. No Phase 1 gets the full monte when they're trying to work on cell safety.

    The new clinical trial differs from the original clinical study in that doses up to 10 times higher will be tested. In addition, the trial will focus on patients with neurologically-complete cervical spinal cord injuries. Because of the anatomy of the spinal cord and the existence of more sensitive outcomes measures to assess movement of the arms and hands, it is currently believed that detection of efficacy is much more likely to occur in patients with cervical injuries. It is this patient population that we anticipate will be the target for the first registration clinical trials of AST-OPC1. The results of the Phase 1/2a clinical trial are expected to provide support for a Phase 2b expansion study that will be conducted to more thoroughly demonstrate safety and efficacy of the product.

    On August 21, 2014, we received notice from the United States Food and Drug Administration (FDA) of clearance to initiate a Phase 1/2a clinical trial of our product, AST-OPC1, in patients with complete cervical spinal cord injury. The approved trial follows the successful completion of the Phase 1 clinical study of the product, and is designed to assess safety and activity of escalating doses of AST-OPC1 in patients with complete cervical spinal cord injuries, the first targeted indication for AST-OPC1.

    AST-OPC1 is a population of cells derived from human embryonic stem cells that contains oligodendrocyte progenitor cells (OPCs). OPCs and oligodendrocytes perform supportive functions for nerve cells in the central nervous system. The foundation for this newly cleared Phase 1/2a clinical trial comes from results from the Phase 1 clinical trial of AST-OPC1, which met its primary endpoints of safety and feasibility when administered to five patients with neurologically-complete, thoracic spinal cord injury. The five patients were administered a low dose of two million AST-OPC1 cells and have been followed to date for two to three years. No serious adverse events were observed associated with the delivery of the cells, the cells themselves, or the short-course immunosuppression regimen used. There was no evidence of expanding masses, expanding cysts, infections, cerebrospinal fluid leaks, increased inflammation, neural tissue deterioration or immune responses targeting AST-OPC1 in the patients. In four of the five subjects, serial MRI scans performed throughout the two to three year follow-up period indicate that reduced spinal cord cavitation may have occurred and that AST-OPC1 may have had some positive effects in reducing spinal cord tissue deterioration.

    The new Phase 1/2a clinical trial will be an open-label, single-arm study testing three escalating doses of AST-OPC1 in 13 patients with subacute, C5-C7, neurologically-complete cervical spinal cord injury. These individuals will have essentially lost all sensation and movement below their injury site with severe paralysis of the upper and lower limbs. AST-OPC1 will be administered 14 to 30 days post-injury. Patients will be followed by neurological exams to assess the safety and activity of the product. Selection of the clinical trial sites is underway and we expect to begin patient enrollment during the first quarter of 2015.

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    Last edited by GRAMMY; 08-27-2014 at 02:43 PM.

  5. #5
    What was the best recovery seen in animal studies?

    Anybody knows?

    Paolo
    In God we trust; all others bring data. - Edwards Deming

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