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Thread: First stem cell drug approved for any indication

  1. #1
    Banned Faye's Avatar
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    Lightbulb First stem cell drug approved for any indication

    Just so we have a basis of comparison:

    PROCHYMAL is currently being evaluated for the treatment of GVHD and Crohn's Disease. The Phase III trial for GVHD is anticipated to be the final trial before the drug is submitted to FDA, Canadian and European regulatory agencies for full approval. PROCHYMAL has been granted Fast Track status by FDA. The Fast Track program was established by FDA to accelerate the development of drugs that show promise for treating life threatening conditions. The drug has also been granted Orphan Drug status by FDA. Orphan Drug designation provides incentives to companies that develop drugs for small, underserved patient populations.


    Basic Eligibility Criteria
    Up to 240 patients will be enrolled in the ( Phase III )trial. Male and female patients are eligible and must be between the ages of 6 months and 60 years old. Patients must have steroid refractory Grade B-D acute GVHD.

    If you have or know someone who has GVHD, or if you would like more information, please contact us at Prochymal@Osiris.com.

    http://www.osiristx.com/clinical_trials_prochymal.php

    Fast Track status and Orphan Drug Status allows for smaller trials:

    We do not need a large clinical trial network!!!

    "There’s far too much unthinking respect given to authority,” Molly Ivins explained; “What you need is sustained outrage.”
    Kerr, Keirstead, McDonald, Stice and Jun Yan courageously work on ESCR to Cure SCI.

    Divisiveness comes from not following Christopher Reeve's ESCR lead.
    Young does ASCR.
    [I]I do not tear down CRPA, I ONLY make peopl

  2. #2
    Banned Faye's Avatar
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    The ChinaSCI net trial could start right now.

    24 million is NOT needed, a smaller trial would suffice.

    "There’s far too much unthinking respect given to authority,” Molly Ivins explained; “What you need is sustained outrage.”
    Kerr, Keirstead, McDonald, Stice and Jun Yan courageously work on ESCR to Cure SCI.

    Divisiveness comes from not following Christopher Reeve's ESCR lead.
    Young does ASCR.
    [I]I do not tear down CRPA, I ONLY make peopl

  3. #3
    Quote Originally Posted by Faye
    The ChinaSCI net trial could start right now.

    24 million is NOT needed, a smaller trial would suffice.
    Faye, I don't understand what you are talking about.

    Wise.

  4. #4
    Banned Faye's Avatar
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    Quote Originally Posted by Wise Young
    Faye, I don't understand what you are talking about.

    Wise.
    I'm with spider on there is no need to do 700 people in a clinical trial. If orphan drug status can be obtained, this is absolutely NOT necessary.

    Osiris is actual proof stem cell therapies can be fast-tracked even in the US.

    Geron and Neuralstem are not far behind for spinal cord injury trials right here in the US, without the need for a huge clinical trial network.

    "There’s far too much unthinking respect given to authority,” Molly Ivins explained; “What you need is sustained outrage.”
    Kerr, Keirstead, McDonald, Stice and Jun Yan courageously work on ESCR to Cure SCI.

    Divisiveness comes from not following Christopher Reeve's ESCR lead.
    Young does ASCR.
    [I]I do not tear down CRPA, I ONLY make peopl

  5. #5
    Prochymal is an ASC therapy. Osiris was able to perform three clinical trials testing the drug in 2006 (Source), because they had 16 centers who knew how to run the trials and evaluate the results (i.e., a clinical trial network) available to them. (Source)

    Yep, clinical trial networks suck.
    ...it's worse than we thought. it turns out the people at the white house are not secret muslims, they're nerds.

  6. #6
    Banned Faye's Avatar
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    Quote Originally Posted by Steven Edwards
    Prochymal is an ASC therapy. Osiris was able to perform three clinical trials testing the drug in 2006 (Source), because they had 16 centers who knew how to run the trials and evaluate the results (i.e., a clinical trial network) available to them. (Source)
    Steven, Steven, ChinaSCINET is also ASC therapy!!

    The Phase II trial is a randomized, prospective, open label trial, being conducted at 16 leading cancer centers in the US.
    You don't think we have 8-10 SCI centers or more?

    You want me to start naming them?

    Kessler,
    Shepherd,
    Craig and so on......

    "There’s far too much unthinking respect given to authority,” Molly Ivins explained; “What you need is sustained outrage.”
    Kerr, Keirstead, McDonald, Stice and Jun Yan courageously work on ESCR to Cure SCI.

    Divisiveness comes from not following Christopher Reeve's ESCR lead.
    Young does ASCR.
    [I]I do not tear down CRPA, I ONLY make peopl

  7. #7
    Quote Originally Posted by Faye
    Steven, Steven, ChinaSCINET is also ASC therapy!!
    I was just adding that info for people who may have thought Prochymal was an ESC therapy. ChinaSCINet will be able to test ESC therapies when they become available.

    You don't think we have 8-10 SCI centers or more?

    You want me to start naming them?

    Kessler,
    Shepherd,
    Craig and so on......
    Who are trained to use the same outcome measures, do therapy the same way, perform trials the same, prepare cells the same way? We have NACTN, but not 16 centers.

    BTW, for the small phase II trial, it took 16 centers to test 32 patients. Without the 16 centers trained to do everything the same way, the small trial would have been impossible.

    In order to receive fast-track status, Osiris had to first complete a two-year Phase I safety trial. (Source) This trial included 46 patients. (Source)

    Most SCI trials will begin as Phase I/II studies, which will be necessary to receive fast-track status. A clinical trial network will help therapies receive fast-track status.
    ...it's worse than we thought. it turns out the people at the white house are not secret muslims, they're nerds.

  8. #8
    The size of the clinical trial network is not related to the size of any clinical trial. No matter the size of a clinical trial, a network will allow it to be completed faster.

    We want a "large clinical trial network". The word "large" is referring to the size of the NETWORK, not the size of the TRIALS.

    Perhaps we shall have to alter the phrasing. We need a "large network for clinical trials". That might be a little tougher to spin.

  9. #9
    Banned Faye's Avatar
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    Quote Originally Posted by Steven Edwards
    Who are trained to use the same outcome measures, do therapy the same way, perform trials the same, prepare cells the same way? We have NACTN, but not 16 centers.

    BTW, for the small phase II trial, it took 16 centers to test 32 patients. Without the 16 centers trained to do everything the same way, the small trial would have been impossible.

    In order to receive fast-track status, Osiris had to first complete a two-year Phase I safety trial. (Source) This trial included 46 patients. (Source)

    Most SCI trials will begin as Phase I/II studies, which will be necessary to receive fast-track status. A clinical trial network will help therapies receive fast-track status.
    Sure it may have taken 16 centers to do the Osiris trial......., but you've not proven to anyone that these were part of an official "clinical trial network".

    For all we know Osiris worked up a protocol, contacted the 16 centers and proceded with the SMALL 32 patient phase II trial( 32 patients!), just like I assume Geron is going to handle theirs and Neuralstem theirs.

    So what I contend is:

    1. There is No need for a subsidized bureaucracy ie clinical trial network
    and

    2. There is No need for large trials as small ones can be completed fast and lead to ODA status even here in the US.
    Last edited by Faye; 02-18-2007 at 12:35 PM.

    "There’s far too much unthinking respect given to authority,” Molly Ivins explained; “What you need is sustained outrage.”
    Kerr, Keirstead, McDonald, Stice and Jun Yan courageously work on ESCR to Cure SCI.

    Divisiveness comes from not following Christopher Reeve's ESCR lead.
    Young does ASCR.
    [I]I do not tear down CRPA, I ONLY make peopl

  10. #10
    Quote Originally Posted by Faye
    Sure it may have taken 16 centers to do the Osiris trial......., but you've not proven to anyone that these were part of an official "clinical trial network".
    16 leading cancer centers, including MD Anderson in Houston, who is experienced in bone marrow transplants. (Source) While they did approach the centers, it's not a stretch to believe each center was experienced at running clinical trials. Or to believe the at least some of centers were involved in the Phase I studies, thus making the 16 centers a multi-year effort.

    Can you tell me 10 centers in the US who have doctors experienced at injecting or transplanting cells into the human spinal cord?

    1. There is No need for a subsidized bureaucracy ie clinical trial network
    Let me ask you this: How would a clinical trial network hurt us? How would reducing a company's workload hurt us?

    2. There is No need for large trials as small ones can be completed fast and lead to ODA status even here in the US.
    Small ones in two years.
    ...it's worse than we thought. it turns out the people at the white house are not secret muslims, they're nerds.

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