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Thread: Asterias Biotherapeutics' Stem Cell Program Is Dead On Arrival

  1. #31
    I forgot to say that around minute 12 of the video it is explained the recovery that was observed in the animal study and the kind of SCI they had.

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

  2. #32
    Quote Originally Posted by c473s View Post
    Interesting that CIRM was the source of the 14 million dollar grant to continue this study. Dr. Oz sits on that board. Maybe you have insight into that ? I am confused by your interpretation of the video in light of the funding grant.
    You're evidentially going to get a play by play commentary off the video I posted...

  3. #33
    Maybe on Monday there is interim news.
    http://asteriasbiotherapeutics.com/i...news-releases/

  4. #34
    Quote Originally Posted by c473s View Post
    Maybe on Monday there is interim news.
    http://asteriasbiotherapeutics.com/i...news-releases/
    Awesome news!!!

    http://asteriasbiotherapeutics.com/a...l-cord-injury/

    Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, today announced that the third patient was successfully dosed at Chicago-based Rush University Medical Center in a Phase 1/2a clinical trial evaluating activity of escalating doses of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI). This represents the final patient treated at the initial low-dose (2 million cells) safety cohort. The results of the study continue to support a robust safety profile for AST-OPC1, with no serious adverse events observed in any of the three treated patients to date.

    The first patient in this cohort was dosed at Shepherd Center in Atlanta and has completed the 2-month post-injection assessment. This patient has progressed from a complete ASIA Impairment Scale (AIS) A injury to an incomplete AIS B injury. The principal investigator at Shepherd Center, Dr. Donald Peck Leslie, said, “This progress in the first patient is very encouraging and is observed in less than 5 percent of our AIS A patients at this stage of their recovery.”

    (This trial will progress up to 20 million cells in the future). So far, so good!


    Last edited by GRAMMY; 08-31-2015 at 12:56 PM.

  5. #35
    Quote Originally Posted by c473s View Post
    Maybe on Monday there is interim news.
    http://asteriasbiotherapeutics.com/i...news-releases/
    The Company expects to begin enrollment of the second dose cohort following Data Monitoring Committee review of the 30-day post-injection safety data from all three patients. The second cohort will enroll five patients who will receive 10 million AST-OPC1 cells. “The safety data in this first cohort now paves the way for testing the higher doses of AST-OPC1 (10-20 million cells) that we believe correspond most closely to the doses that showed the greatest efficacy in animal studies,” commented Dr. Edward Wirth, Chief Medical Officer of Asterias

    It doesn't sound like the next cohort will be delayed. They should be starting up pretty fast. Dr. Wirth will be presenting at W2W this year too! Lots to hear about here.

  6. #36

  7. #37
    - AST-OPC1 Safety Profile Continues To Be Favorable -

    Asterias has dosed 25 subjects with AST-OPC1 in the SCiStar study and a total of 30 subjects including the five subjects from the previous Phase 1 safety trial. The results-to-date, which include subjects from the Phase 1 safety trial who have been followed for as long as seven years, continue to support the safety of AST-OPC1. In particular, there have been no serious, unexpected, adverse events related to AST-OPC1, the injection procedure, or the drug used for immunosuppression in any of the 30 subjects. Additionally, long-term follow up in the Phase 1 safety trial with annual magnetic resonance imaging scans through five years post-injection of AST-OPC1 has shown no evidence of adverse changes in any of the subjects treated with AST-OPC1

    The SCiStar trial completed enrollment in December 2017and is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in 25 subjects with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A subjects have lost all motor and sensory function below their injury site, while AIS-B subjects have lost all motor function but may have retained some minimal sensory function below their injury site. AST-OPC1 is administered 21 to 42 days post-injury. Subjects will be followed by neurological exams and imaging procedures to assess the safety and activity of the product. Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides$14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1. Additional information on the Phase 1/2a trial, including trial sites, can be found http://www.clinicaltrials.gov/ www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website ("https://www.globenewswire.com www.SCiStar-study.com)

    LINK
    Last edited by GRAMMY; 06-06-2018 at 04:49 PM.

  8. #38
    If I understand correctly, the goal of Asteria's therapy is NOT to provide axonal regrowth, neither replacement of lost neurons from the injury, they intend to remyelinate axons. Am I correct ?.. If so, as complete injuries means heavy to damage to both axons and neurons, testing AST-OPC1 on complete injuries is not likely to give spectaculary results.. What do you think ?..

  9. #39

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