Page 1 of 2 12 LastLast
Results 1 to 10 of 18

Thread: To Wise Young re: compassionate use

  1. #1
    Senior Member Stormycoon's Avatar
    Join Date
    Feb 2006
    Location
    B-vILLE Oregon
    Posts
    482

    To Wise Young re: compassionate use

    Hi I know you've been in contact with him in the past, and his company and work were tightly sidelined by the FDA. I started investigating and coMmunicating directly with Dr.Ahfors back in ''06. It seemed his work was being streamlined to a quick clinical approach, then company restructure took place amongst other derailing objects. To cut to the chase, on the New World Labs website it says Regeneration Matrix has been or used ''compassionate use'' [SIZE=13px]Medical professionals use the term “compassionate use” to refer to the treatment of a seriously ill patient using a new, unapproved drug when no other treatments are available.[/SIZE]
    [SIZE=13px]Drugs that are being tested but have not yet been approved by the US Food and Drug Administration (FDA) are called investigational drugs. These drugs are generally available only to people who are taking part in a clinical trial (a research study that is testing the drug). Being able to use one of these drugs when you are not in a clinical trial has many names, but is most commonly referred to as compassionate use.

    I was wondering if you're aware of the outcome or details of any of these studys or if you could try to contact him and check since they wont answer anything.[/SIZE]

  2. #2
    Stormy, thanks. Yes, I have spoke to Jan-Eric Ahlfors several times and was fascinated by what he is trying to do. He was developing ways to differentiate cells consistently and providing scaffolds that would support their growth when transplanted. I have not heard of any clinical trials yet, at least not for spinal cord injury. Unfortunately, I have been spending most of my time in Asia and have not been to meetings that he has been attending.

    Unlike some people who are looking for villains in the slow progress in spinal cord injury trials, I don't consider the FDA to be a major obstacle. In fact, I regard them an ally and not an opponent. If you have a therapy that restores function in chronic spinal cord injury, the FDA will treat it with high priority and give the therapy fast-track and "compassionate use" consideration. In fact, they did that with a Purdue device to stimulate regeneration in the spinal cord, after only phase II trials. This is because there is nothing out there that is effective. However, the moment the first therapy has been approved by the FDA, subsequent therapies will not be as rapidly approved.

    In my opinion, the real obstacles in the United States are the high cost of clinical trials and requirements for safety before you can take something to clinical trials. For example, to transplant cells into the spinal cord and to rehabilitate the people after the surgery, it will cost us $150,000 per person, i.e. at least $50,000 for the surgery, $50,000 for 6-week outpatient rehabilitation, and then $50,000 for 3-6 months of locomotor training. If I want to study the effects of umbilical cord blood mononuclear cells in 40 subjects with spinal cord injury, the clinical costs will cost $6 million. That is not including the cost of hiring the CRO (clinical research organization) to monitor the trial, the company that is required to make clinical grade cells that can be transplanted, clinical trial insurance, the training, shipping, and the personnel needed to apply to the FDA. I am conservatively expecting the total costs of the trial to exceed $200,000 per patient or about $8-10 million. By the way, this is cheap.

  3. #3
    Senior Member lunasicc42's Avatar
    Join Date
    Oct 2004
    Location
    Lutz, Fl USA*********C456
    Posts
    2,334
    "however, the moment the first therapy has been Approved by the FDA, subsequent trials will 'not' be as rapidly Approved ".... Was that a typo?

    I thought it will speed up

  4. #4
    Senior Member Stormycoon's Avatar
    Join Date
    Feb 2006
    Location
    B-vILLE Oregon
    Posts
    482
    Yes it is quite apparent throughout the history of CareCure, mosts opinion of the FDA is a negative one. Some countries more/less lenient. His site even states, "with realistic FDA hurdles" in regards to the obvious. Given why he upped and went back to Canada if they're any more of the emphasized. I realize you have to comply with every standard they establish into the framework and you being an accredited M.D. along side their policys aren't going to bash them.
    As far as "If you have a therapy that restores function in chronic spinal cord injury, the FDA will treat it with high priority and give the therapy fast-track and "compassionate use" consideration" I don't want to go on a rant but theres been an array of therapies shown to do that, come on man!
    I respect and thank you for your diligent work. Thanks for your reponse.

  5. #5
    Super Moderator Sue Pendleton's Avatar
    Join Date
    Jul 2001
    Location
    Wisconsin USA
    Posts
    11,007
    Actually Wise is right on the money on this. Once any regenerative therapy is found that restores ANY function and is reasonably safe than the next therapy is competing against the first one instead of against a baseline injury especially in chronic cases. In acutes the most a new therapy need beat is methylprednisolone and that still has never been proven to not help preserve the function that the trials showed and the FDA approved. So if new therapy one regenerates 3 neurological levels or 20% of the cord then the next up has to not only equal or better the safety of therapy one but cause substantially better performance like 6 neuro levels or 40% of the cord or to do the same in much better time.

    The trial creations may speed up as hospitals and rehabs get better at the surgeries, tasking of rehab and data collection and correlating but the FDA will look for a better outcome. Right now all we have is methylprednisolone at the acute stage of the first 8 and preferably 3 hour mark. There is no approved treatment for chronic injuries right now.

    I think funding may speed up as countries realize and charitable donors see that if partial cures are doable than full cures should be also. People like to back a winner.

  6. #6
    Senior Member Stormycoon's Avatar
    Join Date
    Feb 2006
    Location
    B-vILLE Oregon
    Posts
    482
    what happened with that field oscilating implant unit that showed great success/?

  7. #7
    It is available for prescription under the compassionate use program, after just a phase II study. Wise.

  8. #8
    How do you qualify for compassionate use of a drug or treatment? I've never heard of this in Canada.

  9. #9
    Compassionate use is a program through the FDA (USA). I don't know if Canada has anything comparable:

    http://www.fda.gov/ForConsumers/ByAu.../ucm176098.htm

    (KLD)

  10. #10
    Super Moderator Sue Pendleton's Avatar
    Join Date
    Jul 2001
    Location
    Wisconsin USA
    Posts
    11,007
    James, if Canada has something like our compassionate use program you might try searching for Fidia Inc and their drug Sygen or GM-1. It remained available under compassionate use after going through phase 2 for SCI until the US part of the company ran out of money. It is an Italian company I think and Sygen had a good safety record for other uses in Europe. It should lead you to the Canadian agency in charge of such things.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •