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Thread: question about miami project newsletter that I got today

  1. #1
    Senior Member lunasicc42's Avatar
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    question about miami project newsletter that I got today

    it says that they got approval from the FDA for expanded access for a single patient to perform a bone marrow mesenchymal stemcell treatment for Spinal cord injury .
    What does that mean ?

    It doesn't specify Acute or chronic ,thoracic or cervical ...just basically what I mentioned .
    Anyone have any further information ?
    "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!!!! "


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  2. #2
    Hey luna, at their Sports Legends Dinner in Sept I remember them saying in the video presentation they planned to move to chronics with the MSC's.

  3. #3
    Senior Member lunasicc42's Avatar
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    k,thanks
    "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
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  4. #4
    Am I reading that right, single, as in 1 patient will be part of this study? LOL.

  5. #5
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by Barrington314mx View Post
    Am I reading that right, single, as in 1 patient will be part of this study? LOL.

    I dunno but I guess so .I e-mailed them with a request to get further information but have not heard back yet
    "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
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  6. #6
    Senior Member lunasicc42's Avatar
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    does anyone else get the miami project e-newsletter?I can't figure out how to take a screenshot with my setup
    "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
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  7. #7
    Senior Member lunasicc42's Avatar
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    test

    sorry ,this is my best try to relay the information





    APRIL 2014
    2 MINUTE UPDATE

    RESEARCH | PARALYSIS SUPPORT | EVENTS | CHAPTERS | VIDEO | DONATE | PUBS | NEWS | CONTACT

    SINGLE PATIENT APPROVAL FROM THE FDA TO PERFORM A BONE MARROW MESENCHYMAL STEM CELL TREATMENT REGIMAN

    Miami Project to Cure Paralysis researchers Drs. Barth A. Green, James Guest and W. Dalton Dietrich, along with Dr. Joshua Hare of the University of Miami’s Stem Cell Institute, recently received permission from the FDA for expanded access for a single patient to perform a bone marrow mesenchymal stem cell (BMSC) treatment for spinal cord injury (SCI). The FDA has approved this one-time research intervention, and The Miami Project to Cure Paralysis / University of Miami will use the results from this study to help them develop bone marrow stem cell transplantation as a potential treatment method for SCI. The results from this study will also be valuable to other scientists studying SCI and will be published for other researchers to use.

    A bone marrow stromal stem cell is a cell of the bone marrow that has the potential to differentiate into several cell types. In spinal cord injury studies these cells have been shown to localize around blood vessels and release molecules that can enhance tissue survival and reduce the inflammatory response. Infusing bone marrow stromal stem cells into the spinal fluid is considered research and not approved by the Food and Drug Administration (FDA) as a medical treatment. The investigators do have FDA approval to transplant bone marrow stromal stem cells in other conditions such as problems with the heart with no evidence of long-term harmful side effects.

    12th ANNUAL BUONICONTI FUND CELEBRITY GOLF INVITATIONAL
    AT THE BEAR'S CLUB WITH JACK NICKLAUS PRESENTED BY TUDOR GROUP
    Sunday, May 4 and Monday, May 5, 2014 Jack and Barbara Nicklaus with Lynn and Nick Buoniconti

    It’s time to reserve your spot to play golf on the absolutely amazing course, The Bear’s Club in Jupiter, Florida for the 12th annual Buoniconti Fund Celebrity Golf Invitational hosted by golf legend Jack Nicklaus at his home course. This is your chance to join Jack Nicklaus along with Nick and Marc Buoniconti and their Celebrity Friends for the one-of-a-kind tournament, Celebrity Dinner and Buy It Now Store with amazing jewelry, sports memorabilia, trips and more. Golf with a celebrity on the magnificent Nicklaus designed course and participate in a fun competition on Sunday, May 4 and Monday, May 5, 2014. Since its inception, the event has raised critical funding for the ongoing research programs at The Miami Project to Cure Paralysis. Special thanks to our Official Sponsor, Delta Air Lines and our Hotel Sponsor, PGA National Resort & Spa.

    Call today to reserve your foursome! For more information on sponsorships or purchasing a foursome, please call Stephanie Sayfie Aagaard at 305-243-4656 or email saagaard@miami.edu

    ASH'S ADVICE

    Ashley MooreFinally, it's spring! I know all of you living up north are rejoicing over the end of a long winter. The weather has turned from a hostile, frozen tundra to a beautiful, sunny paradise. Let's take advantage of it and go outside. Spring is the time to get up and get active again, both in mind and body. If you are new to the whole spinal cord injury thing, you may be wondering whether keeping active during spring even applies to you anymore. I am here to tell you it does. It is even more important for people like us to keep active in mind and body because living with a spinal injury makes it even harder to maintain good health on a daily basis. Below, I have listed a few tips to keep your mind and body active this spring.

    • Go outside and feel the warmth of the sun! Remember my article on Poikilothermia? Living with a spinal cord injury does not allow one to regulate body temperature. Going out and doing things in the sunlight, under the protection of sun block or clothing of course, can not only warm you up, but put your mind in a better, more healthy place. According to Rodale News, light deficiency can cause "fatigue, irritability, depression, carbohydrate craving, sleep problems, and weight gain." Only thirty minutes of sunlight a day can dramatically improve these symptoms due to increasing transmitter levels in your brain, giving one a feeling of relaxed well-being. Instead of staying inside where your mind has nothing to do, go outside and keep your mind happily active.

    • Keep learning! Whether it be learning a new story by reading a novel, learning about other people or places in this world by watching a documentary, or learning more about living and coping with a spinal cord injury by researching online, keep your mind active this spring by filling it with knowledge. I know how scary and confusing it is when you are forced to learn how to live life with a spinal cord injury. Learning more about the injury and how others are coping with it can give you a new source of hope.

    • Go to physical therapy! Normally, people with new spinal cord injuries attend rehabilitation to learn how to adapt to daily tasks like getting in and out of bed, self grooming, and eating with his or her new limitations. Physical therapy also works on improving muscle strength. People often see themselves regain some arm or leg movement after extensive physical therapy. Rehabilitation can come in all sorts of forms. Fun things to do during spring that fall under the physical therapy category include sports and yoga. Yes, even with a spinal cord injury you can play a sport or go to a yoga class! Check out the Paralympics website and see how many sports you can do to keep your body active even in a wheelchair. Going to yoga can keep your mind active as well. Get online and look for classes.

    These tips are good to keep in mind, but I have one more to tell you about. On Saturday, April 5, 2014, The Miami Project to Cure Paralysis hosted their Fourth Annual Community Open House. Individuals from all over with new spinal cord injuries came together at The Lois Pope LIFE Center to talk about health and wellness research, meet the scientists, and go on a behind the scenes tour of The Miami Project. It is a wonderful way for a person living with a spinal cord injury to keep his or her mind and body active and educated on the process to a cure.

    RUN, WALK OR ROLL FOR THE BUONICONTI FUND
    (COMPLIMENTARY ADMISSION)

    Have you ever run a race with no finish line? Compete in the Wings For Life World Run and see how you fare when the finish line is chasing you. Everyone starts at the BB&T Center and the course heads into Everglade National Park, and where you finish is up to you! This innovative run will push you to extremes while raising funds for research into spinal cord injury. In this race where everyone is running for those who can't, the top male and female finishers in Sunrise will earn a spot in any race venue in 2015, and the top runner wins a trip around the world.

    It's going down on May 4, 2014, starting at 6 AM ET at the BB&T Center, come out to challenge yourself and run for a cure!

    First come, first serve...complimentary spaces are limited and you must reserve your space by Friday, April 25th at 12:00pm (EST). Call (305) 243-4656 today to reserve your space!

    4th ANNUAL COMMUNITY OPEN HOUSE

    2014 Community Open HouseThe Miami Project to Cure Paralysis held its’ 4th annual Community Open House event on April 5, 2014. The first part of the afternoon was a very interactive discussion about health and wellness research related to spinal cord injury. Important topics brought up were about spasticity, pain, exercise, mobility, and sleep disruptions. Our scientists really value these opportunities to hear real life experiences from various individuals living with paralysis.

    The second part of the afternoon focused on basic science research, including the characteristics of and use of Schwann cells for repair strategies, high tech approaches for discovery of regenerative strategies, and deep brain stimulation to manipulate motor signals in the spinal cord.

    Finally, the day was rounded out with behind the scenes tours of a cell biology lab, regeneration and microscopy lab, human sensory and pain lab, and a robotic exercise/locomotion lab. We welcome these special opportunities to open our doors to the public, answer questions, and hear feedback.

    NATIONAL CHAPTERS OF THE BUONICONTI FUND

    The Woody Foundation hosts its 3rd annual Woody Golf Classic to benefit the Miami Chapter of The Buoniconti Fund on Thursday, May 1 at International Links Miami. Foursomes and sponsorships are available, please call 305-243-3863.

    Join the Orlando Chapter on Saturday, May 10 for Island Luau Jam at Winter Park Farmer’s Market in Orlando, FL. Sample some of the area’s tastiest food and cocktails, and dance the night away with RockIt Fly and Mix on Wheels. For tickets and sponsorship, visit www.thebuonicontifund.com/orlando

    The Miami Chapter invites you to attend their annual Happy Hour at Scotty’s Landing in Coconut Grove on Thursday, May 8. Relax and enjoy good friends near Biscayne Bay with music from Live Bait. Tickets and sponsorship available at www.thebuonicontifund.com/miami

    Training to participate in your next race, walk, mudder or triathlon? Help us cross the finish line in finding a cure for paralysis while you improve your endurance and test your limits. Check out our “Chapters Challenge” and raise funds and awareness for The Miami Project to Cure Paralysis http://chapterschallenge.thebuonicontifund.com

    There’s no better time to raise funds and awareness for spinal cord injury research. You can help us find a cure! If you’d like to be more involved in your local Chapter or start a new Chapter, please contact Kristin Wherry, Director of National Chapters, at bfchapters@med.miami.edu or call (305) 243-3863.

    BILL SIMS

    Bill SimsBill Sims started at The Miami Project in 1988 in support of the fundraiser Wheels Across America. The event followed and supported a paralyzed rider in a wheelchair as he travelled from Los Angeles to New York to raise money and awareness of The Miami Project’s research efforts. His knowledge and love for the organization quickly became apparent, and for the next 26 years he served in many capacities including manager of information systems and operations manager. No role or title was beyond Bill and his expertise. Helping The Miami Project improve in all areas was his main mission. He dedicated his life to The Miami Project. Over the years he contributed greatly in streamlining The Miami Project’s computer and telecommunications systems, ensuring they were integrated and working properly. In the operation of the Lois Pope LIFE Center, Bill worked tirelessly on the upkeep and its smooth operation. As further proof of his complete dedication to the cause, he stayed to ensure the integrity of the building and its systems during countless hurricanes and the Y2K computer scare.

    A native of Syracuse, New York, Bill demonstrated early his willingness to help others. Before coming to Miami he worked as operations manager and then CEO of the Onondaga Community College Student Services Association for more than 10 years. At the same time, he also worked as an Emergency Medical Technician in the Syracuse area. Those who knew him best at The Miami Project will remember his infectious smile, his love of reminiscing about past events or his beloved dogs, and his dry sarcastic wit. He will be deeply missed by his many friends and his Miami Project “family”.
    JOIN, FOLLOW OR BE PART OF OUR SOCIAL MEDIA NETWORK

    The Buoniconti Fund to Cure Paralysis/The Miami Project are on Facebook, Twitter and Google+!

    Join our Fan Page on Facebook, Follow us on Twitter and Be Part of our Google+ circle today to get the latest news on spinal cord injury research, events, pictures, videos, links to articles and much more.

    HUMAN STUDIES FOR CHRONIC SCI BEING CONDUCTED AT THE MIAMI PROJECT

    The Miami Project clinical researchers currently have 17 research studies available for people who have had a spinal cord injury. They are investigating questions regarding exercise science, rehabilitation training, pain, male fertility, aging, and neuroprosthetics. Learn more about these studies and how to participate. Additionally, there are important research opportunities for people with paralysis to participate in online surveys about factors that encourage or discourage participation in clinical trials and factors that influence weight management.

    SHOP AT OUR eBAY STORE TODAY!!

    We have new items in our eBay store! Shop for a cause today!

    TREE OF HOPE

    Tree of HopeHonor someone special and have their name engraved on the Tree of Hope!

    At the entrance to The Miami Project's Family and Education Center stands the Tree of Hope. This bronze sculpture of memory and honor recognizes the generosity of donors to an annual giving campaign that will raise more than $300,000 for research. With a gift of $100 to $35,000, your name - or the name of someone you would like to honor - will be engraved on the Tree of Hope.

    THE 2014 WINTER EDITION OF THE PROJECT MAGAZINE IS AVAILABLE!

    Research Review 2013The latest edition of The Project magazine is the 2013 Research Review, which highlights the work completed by Miami Project scientists during 2013.

    Our feature article focuses on the inflammation after spinal cord injury (SCI) and the technological advances we are making. This edition includes additional stories about staying healthy after SCI, Schwann cell transplantation after severe peripheral nerve injury, and our active clinical trials and studies. Also included are spotlight stories on three of our faculty members, Drs. Bunge, Green, and Liebl. Finally, all of our 39 faculty members are profiled along with listings of their publications and active grants from 2013; there is a joint message from the Scientific Director and the Chairman; highlights of training our next generation of neuroscientists; and details of many of our educational activities. Don’t miss it!!



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    "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

  8. #8
    Their trial is set up for a total of 8 patients and it's based on dose escalation. I would imagine the initial patient got a very low dose and there wasn't any adverse events reported so the FDA gave the nod to increase the dosage in the next single patient only. It's a slow methodical process that the FDA monitors very closely.

    http://www.clinicaltrials.gov/ct2/sh...project&rank=1

  9. #9
    Senior Member lunasicc42's Avatar
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    Yes ,that is a listing for the Acute Schwann cell trial ,(relatively old news )
    This new newsletter that I got yesterday said that they got another permission to test MSCS .I wish I could present the newsletter .does anyone else get the miami project e-newsletter ?
    "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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