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Thread: Have the Miami Project already strated with they clinical trial ???

  1. #1

    Have the Miami Project already strated with they clinical trial ???

    Hi guys

    I found this in a spanish forum is a message from Nick Buoniconti and Marc Buoniconti to one of the members check this out....

    Una carta que recibi hoy de Nick Buoniconti y Marc Buoniconti...

    WE'VE BEGUN
    Dear Friend:
    This has been one of the most exciting days ever at The Miami Project and The Buoniconti Fund! As one of The Miami Project’s biggest supporters, I wanted you to be one of the first to know that Miami Project doctors and scientists have performed the first ever FDA approved Schwann cell transplantation in an individual with a new spinal cord injury.
    The transplantation procedure was conducted by Drs. Allan Levi and Jim Guest. The participant had a neurologically complete thoracic spinal injury and received the transplantation of autologous Schwann cells approximately 4 weeks post-injury. There have been no adverse events and the team is moving forward with the trial. The procedure is a Phase 1 clinical trial designed to evaluate the safety and feasibility of transplanting the patient’s own Schwann cells.
    “This historic clinical trial represents a giant step forward in a field of medicine where each tangible step has tremendous value. The trial and these first patients in this trial specifically, are extremely important to our mission of curing paralysis,” said Dr. Barth Green, Co-Founder.
    “The Miami Project team includes hundreds of scientists, clinicians, and technicians who have joined hands to make the ‘impossible possible’, for which this trial is a key goal and dream now being realized. This achievement reaffirms that the tens of millions of dollars and the incalculable work hours were well invested in this first of a kind human Schwann cell project.”
    Led by Miami Project Scientific Director Dr. Dalton Dietrich, the Schwann cell clinical trial team at The Miami Project is composed of a multi-disciplinary group of basic science and clinical faculty members, scientific staff, and regulatory personnel focused on advancing the trial.
    “As a basic scientist, the hope is always to increase knowledge and discovery. Not every day are you able to see that translated into the clinical realm with the hopes of bettering the lives of those suffering, so this Phase I clinical trial is a vital step for the field of SCI research, and for The Miami Project team that has been working diligently on this therapeutic concept for more than a quarter of a century. This trial, when completed successfully, will lay the critical foundation for future cell-based therapies to target spinal cord injuries,” said Dr. Dietrich.
    Because of YOUR support and the dedication of our scientists and doctors, a cure for paralysis is on the horizon. No longer are we just talking about cells in petri dishes with the hopes that some day in the distant future they could be translated into a possible new therapy. Today, we are actually operating on people and testing the safety of Schwann cells in people with a spinal cord injury.
    This is such an exciting time at The Miami Project and I hope we can count on your continued support. Thank you for believing in us.
    Sincerely,
    Nick Buoniconti Marc Buoniconti
    keep (rolling) Walking

    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  2. #2
    Yes, the first transplant was announced in the news yesterday. It's good that it's finally moving forward as it's been a long time coming.

    This is such an exciting time at The Miami Project and I hope we can count on your continued support. Thank you for believing in us.
    Sincerely,
    Nick Buoniconti Marc Buoniconti
    I have no idea if or how they intend to move to chronic applications though. Certainly Dietrich and Guest didnt seem to allude to a chronic application. In which case, it's a hard sell to ask the chronic community to donate to MP.

  3. #3
    Excellent. Wise.

  4. #4
    Finally!!!!! I hope things go smooth for this trial.

  5. #5

    Thumbs up

    Quote Originally Posted by Johnnie Walked View Post
    Hi guys

    I found this in a spanish forum is a message from Nick Buoniconti and Marc Buoniconti to one of the members check this out....

    Una carta que recibi hoy de Nick Buoniconti y Marc Buoniconti...

    WE'VE BEGUN
    Dear Friend:
    This has been one of the most exciting days ever at The Miami Project and The Buoniconti Fund! As one of The Miami Project’s biggest supporters, I wanted you to be one of the first to know that Miami Project doctors and scientists have performed the first ever FDA approved Schwann cell transplantation in an individual with a new spinal cord injury.
    The transplantation procedure was conducted by Drs. Allan Levi and Jim Guest. The participant had a neurologically complete thoracic spinal injury and received the transplantation of autologous Schwann cells approximately 4 weeks post-injury. There have been no adverse events and the team is moving forward with the trial. The procedure is a Phase 1 clinical trial designed to evaluate the safety and feasibility of transplanting the patient’s own Schwann cells.
    “This historic clinical trial represents a giant step forward in a field of medicine where each tangible step has tremendous value. The trial and these first patients in this trial specifically, are extremely important to our mission of curing paralysis,” said Dr. Barth Green, Co-Founder.
    “The Miami Project team includes hundreds of scientists, clinicians, and technicians who have joined hands to make the ‘impossible possible’, for which this trial is a key goal and dream now being realized. This achievement reaffirms that the tens of millions of dollars and the incalculable work hours were well invested in this first of a kind human Schwann cell project.”
    Led by Miami Project Scientific Director Dr. Dalton Dietrich, the Schwann cell clinical trial team at The Miami Project is composed of a multi-disciplinary group of basic science and clinical faculty members, scientific staff, and regulatory personnel focused on advancing the trial.
    “As a basic scientist, the hope is always to increase knowledge and discovery. Not every day are you able to see that translated into the clinical realm with the hopes of bettering the lives of those suffering, so this Phase I clinical trial is a vital step for the field of SCI research, and for The Miami Project team that has been working diligently on this therapeutic concept for more than a quarter of a century. This trial, when completed successfully, will lay the critical foundation for future cell-based therapies to target spinal cord injuries,” said Dr. Dietrich.
    Because of YOUR support and the dedication of our scientists and doctors, a cure for paralysis is on the horizon. No longer are we just talking about cells in petri dishes with the hopes that some day in the distant future they could be translated into a possible new therapy. Today, we are actually operating on people and testing the safety of Schwann cells in people with a spinal cord injury.
    This is such an exciting time at The Miami Project and I hope we can count on your continued support. Thank you for believing in us.
    Sincerely,
    Nick Buoniconti Marc Buoniconti
    Here complete news: http://www.themiamiproject.org/page.aspx?pid=1076

  6. #6
    I know every bit helps but ughh... Three years for the data from a phase 1 study on acutes?

  7. #7
    here is today's article:


    Miami Project Performs First Schwann Cell Transplant
    Jan


    MIAMI (CBSMiami) – The Miami Project to Cure Paralysis has taken their first step in a clinical trial involving the transfer of Schwann cells to assist in the healing of a spinal cord injury.

    Led by Miami Project Scientific Director Dr. Dalton Dietrich, the Schwann cell clinical trial team performed the first ever FDA approved Schwann cell transplantation in an individual with a new spinal cord injury.

    “This historic clinical trial represents a giant step forward in a field of medicine where each tangible step has tremendous value. The trial and these first patients in this trial specifically, are extremely important to our mission of curing paralysis,” said Dr. Barth Green, neurosurgeon and Co-Founder and Chairman of The Miami Project.

    read....

    http://miami.cbslocal.com/2013/01/24...ll-transplant/

  8. #8
    Quote Originally Posted by ay2012 View Post
    I know every bit helps but ughh... Three years for the data from a phase 1 study on acutes?
    That's the standard procedure..

    You may want to read this:

    http://www.bio-itworld.com/issues/20...o-the-FDA.html

    Risk aversion is the inherent enemy of progress....

    This is the part 1:

    http://www.bio-itworld.com/2011/08/2...ess-model.html

    This is also very interesting if you have time:

    http://pipeline.corante.com/archives...py_science.php

    If you had time to read all the above you are probably discouraged... so this may help:

    http://www.youtube.com/watch?v=WO4tIrjBDkk

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

  9. #9
    Senior Member Moe's Avatar
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  10. #10
    Senior Member lunasicc42's Avatar
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    an e-mail that I sent to the miami project concerning this Acute trial and it's relevance to the chronic trial...

    hello, my name is anthony waters and I have a question about the Spinal
    cord injury trial:

    Is it correct to assume that if this trial proves safety, that it will
    also help with the starting of the chronic trials to commence based on
    safety data collected from this trial, or will it start anew separate?

    Hi Anthony,
    Yes, you are correct!
    Best wishes,
    Kim
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

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