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Thread: Medical College selected as one of 7 sites for first clinical trial to use human embr

  1. #1

    Medical College selected as one of 7 sites for first clinical trial to use human embr

    is this a new one?



    Medical College selected as one of 7 sites for first clinical trial to use human embryonic stem cells

    By Mark Johnson of the Journal Sentinel
    July 11, 2011 5:26 p.m. |(1) Comments

    The Medical College of Wisconsin is to be one of seven sites for the first trial to use human embryonic stem cells in the treatment of spinal cord injuries.

    Only 10 people will be enrolled nationwide in this Phase 1 study to test the safety and tolerability of cells cells called oligodendrocyte progenitor cells, which have been grown from human embryonic stem cells. Oligodendrocyte progenitor cells are the forerunners of a kind of brain cell that provides insulation to the wiring system in the brain.



    read...

    http://www.jsonline.com/blogs/news/125381128.html

  2. #2

    Angry

    Quote Originally Posted by manouli View Post
    is this a new one?



    Medical College selected as one of 7 sites for first clinical trial to use human embryonic stem cells

    By Mark Johnson of the Journal Sentinel
    July 11, 2011 5:26 p.m. |(1) Comments

    The Medical College of Wisconsin is to be one of seven sites for the first trial to use human embryonic stem cells in the treatment of spinal cord injuries.

    Only 10 people will be enrolled nationwide in this Phase 1 study to test the safety and tolerability of cells cells called oligodendrocyte progenitor cells, which have been grown from human embryonic stem cells. Oligodendrocyte progenitor cells are the forerunners of a kind of brain cell that provides insulation to the wiring system in the brain.



    read...

    http://www.jsonline.com/blogs/news/125381128.html
    Oh my God, this is exactly the type of trial, therapy that i would benefit from and wouldnt you know it, ITS FOR ACUTES. I'm very happy for ACUTES but man we Chronics need some love too.


    manouli,

    i dont know how you do it but thank you very much for finding these kind of articles.
    Last edited by ineedmyelin; 07-11-2011 at 11:14 PM. Reason: edit

  3. #3
    Moderator jody's Avatar
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    soon though, things are rolling in the right direction. maybe it really will be 3-5 years to a cure. it seems to be getting closer and more real than in the past.

    thanx manouli for your articles.

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    Thanks Manouli for keeping HOPE ALIVE!!!

  5. #5
    No Manoluli, this is not a new one.

    This is the Geron safety Phase 1 trial that was started last year and has been highly publicized. The Medical Center of Wisconsin is one of the 7 medical facility enrolling sites. Not new clincal information, but GERON is working hard on regenerative medicine. We will see where their current studies take them and exactly what clinical trials will be initiated. Geron is the first company doing human embryonic cell trials for SCI. Additional information and video's of the CEO can be found here. unite2fightparalysis.org/clinicaltrials

    hESC - Derived Oligodendrocyte Progenitor Cells (GRNOPC1)

    Spinal Cord Injury
    The Phase 1 clinical trial is designed to assess the safety and tolerability of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) Impairment Scale grade A subacute thoracic spinal cord injuries. Patients who will be eligible for the Phase 1 trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T11 spinal segments and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury.
    Although the primary endpoint of the trial is safety, the protocol includes secondary endpoints to assess efficacy, such as improved neuromuscular control or sensation in the trunk or lower extremities.
    Geron has selected seven U.S. medical centers as candidates to participate in this study and in planned protocol extensions. The trial is currently open for enrollment at the following sites:
    Stanford University/Santa Clara Valley Medical Center
    Palo Alto/San Jose, CA
    Contact: Maria Coburn
    Telephone: 650-723-5575
    Email: GRNOPC1@stanford.edu
    Principal Investigator: Gary K. Steinberg, M.D., Ph.D.

    Shepherd Center
    Atlanta, GA
    Contact: Issi Clesson
    Telephone: 404-350-7651
    Email: ismari_clesson@shepherd.org
    Contact: Michelle Tidwell
    Telephone: 404-367-1317
    Email: michelle_tidwell@shepherd.org
    Principal Investigator: David Apple, M.D.

    Northwestern Medicine
    Chicago, IL
    Contact: Narina Simonian
    Telephone: 312-695-1607
    Email: n-simonian@northwestern.edu
    Principal Investigator: Richard G Fessler, M.D., Ph.D.

    Thomas Jefferson University Hospital
    Philadelphia, PA
    Contact: Mary Ann Sheridan
    Email: maryann.sheridan@jefferson.edu
    Contact: Kristin Salgado
    Email: kristin.salgado@jefferson.edu
    Principal Investigator: James S Harrop, MD

    The Medical College of Wisconsin
    Milwaukee, WI
    Contact: Laura Wollenweber
    Telephone: 414-805-5403
    Email: GERONstudy@mcw.edu
    Principal Investigator: Shekar Kurpad, MD
    Last edited by GRAMMY; 07-12-2011 at 01:38 PM.

  6. #6
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    How much time Geron will take to start trials with chronics? 2 to 3 years or before?

    Will they be taking all kind of injuries including lower injuries or criteria will remain same?

  7. #7
    Nobody knows yet. They've only just enrolled 2 people into phase 1 safety acutes. The estimated completition date isn't until October 2012. I very much doubt before 2-3 yrs... but who knows.
    Last edited by GRAMMY; 07-12-2011 at 04:07 AM.

  8. #8
    Senior Member lunasicc42's Avatar
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    grammy: where can I read that geron intends human studies for chronics? I have read so many conflicting stories and opinion, but not real literature
    "That's not smog! It's SMUG!! " - randy marsh, southpark

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  9. #9
    Senior Member tarheelandy's Avatar
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    Don't forget that Neuralstem has submitted and IND for chronics. They will be using the technology they are currently using in their ALS trial in Atlanta @ Emory.

  10. #10
    Quote Originally Posted by lunasicc42 View Post
    grammy: where can I read that geron intends human studies for chronics? I have read so many conflicting stories and opinion, but not real literature

    http://www.geron.com/GRNOPC1Trial/grnopc1-sec1.html
    HUMAN EMBRYONIC STEM CELLS


    Human embryonic stem cells (hESCs) are nature’s master stem cells. They are a self‑renewing source for the scalable manufacturing of functional replacement cells for every tissue and organ in the body. The hESCs with which Geron works were derived from surplus in vitro fertilized embryos originally created as part of an in vitro fertilization (IVF) procedure. The embryos, which would otherwise have been destroyed, were donated for research by the parental donors under informed consent. The hESC line that is used to produce GRNOPC1 is the H1 line. Studies using this line qualify for U.S. federal research funding, although no federal funding was received for the development of the product or to support the clinical trial.




    hESCs have two characteristics that make them different from other naturally occurring stem cells. First, they are immortal – they express the enzyme telomerase that enables the cells to divide endlessly in tissue culture. This allows scalable manufacturing of therapeutic cells derived from a master cell bank. Second, hESCs have the ability to differentiate into any of the more than 200 functional, specialized cells that make up the tissues and organs of the human body. Geron scientists have learned how to grow undifferentiated hESCs under carefully defined conditions, enabling them to be numerically expanded to form large cell banks (hundreds of vials of frozen undifferentiated hESCs) that serve as uniform starting material for manufacturing procedures that convert the undifferentiated hESCs into functional therapeutic cells. Geron scientists have learned how to manufacture seven different types of functional cells from hESCs:
    • neural cells to treat chronic degenerative diseases of the nervous system;
    • cardiomyocytes for the treatment of congestive heart failure and myocardial infarction;
    • islets for the treatment of diabetes;
    • chondrocytes for the treatment of osteoarthritis;
    • hepatocytes for ADME drug testing;
    • dendritic cells cells for immunotherapy for cancer and infectious diseases; and
    • osteoblasts for the treatment of osteoporosis and bone fractures.
    These functional cells are produced from hESCs by specific processes in which the frozen, banked hESCs are thawed, numerically expanded in their undifferentiated state and then treated with specific biologicals and growth factors to induce them to differentiate into specific functional cell types for therapeutic use. Each cell type requires a unique manufacturing “recipe.” All of the differentiated cells produced by the manufacturing process are normal, healthy cells that have not been genetically modified and which have characteristics similar to the equivalent “natural” cell type present in the body.



    Geron is working in the field of regenerative medicine. Results of the Phase 1 safety trial can pave the way for chronic trials to begin. No other trials can really be designed or implemented until they have a look at this Phase 1 safety in acutes.
    Last edited by GRAMMY; 07-12-2011 at 02:57 PM.

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