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    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
    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; 11 Jul 2011, 11:14 PM. Reason: edit
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

    Comment


      #3
      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.

      Comment


        #4
        Thanks Manouli for keeping HOPE ALIVE!!!

        Comment


          #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; 12 Jul 2011, 1:38 PM.
          http://spinalcordresearchandadvocacy.wordpress.com/

          Comment


            #6
            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?

            Comment


              #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; 12 Jul 2011, 4:07 AM.
              http://spinalcordresearchandadvocacy.wordpress.com/

              Comment


                #8
                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

                "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

                Comment


                  #9
                  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.

                  Comment


                    #10
                    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; 12 Jul 2011, 2:57 PM.
                    http://spinalcordresearchandadvocacy.wordpress.com/

                    Comment


                      #11
                      Originally posted by tarheelandy View Post
                      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.
                      I am anxious to see them move forward!
                      http://spinalcordresearchandadvocacy.wordpress.com/

                      Comment


                        #12
                        Originally posted by Jawaid View Post
                        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?
                        Geron has only enrolled 2 patients in Phase 1 safety for the GRNOPC-1 in complete acutes. Many more patients and a review of the findings will be needed before they can even consider additional criteria for chronics...I highly doubt that all the work can be completed in a 2-3 year time frame. They have a long way to go before making future trial decisions.
                        They are literally at an incubator stage, so nobody knows for sure what the adult chicken will look like even if they can get it there.
                        Last edited by GRAMMY; 12 Jul 2011, 3:32 PM.
                        http://spinalcordresearchandadvocacy.wordpress.com/

                        Comment


                          #13
                          @ grammy: thank you for that info

                          @ tarheelandy: didn't neuralstem file that IND for chronics initially quite some months ago. Isn't the FDA suppose to respond like in 3 months? I thought I heard that somewhere?
                          Anyway, it's like taking Forever. I am more interested in neuralstem than geron
                          "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

                          Comment


                            #14
                            Originally posted by tarheelandy View Post
                            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.
                            Almost a year ago we saw this press release for a SCI clincial trial.
                            16 total patients.
                            Chronic SCI (1 to 2 years) post injury.
                            Asia A
                            Thoracic Patients First
                            Cervical Patients Second


                            Public release date: 25-Aug-2010
                            Neuralstem files FDA application for first chronic spinal cord injury stem cell trial

                            Neuralstem, Inc. (NYSE Amex:CUR) announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin a Phase I safety clinical trial for chronic spinal cord injury with its spinal cord stem cells. This multicenter Phase I safety trial will enroll a total of 16 long-term, or chronic, spinal cord injury patients, with an American Spinal Injury Association (ASIA) Grade A level of impairment, one-to-two years post-injury. ASIA A refers to a patient with no motor or sensory function in the relevant segments and is considered to be complete paralysis.
                            "We are filing an application with the FDA to test our spinal cord stem cells in a second medical condition with substantial unmet needs," said Neuralstem CEO and President, Richard Garr. "The proposed trial is primarily designed to test the safety of both our cells and delivery method in chronic spinal cord injury patients."
                            "We are very encouraged by what we have learned transplanting the first six ALS (Amyotrophic Lateral Sclerosis) patients in our FDA-approved trial in Atlanta," said Chief Scientific Officer and Chairman of Neuralstem's Board of Directors, Karl Johe, Ph.D. "We believe that it is the right time to leverage what we have learned with ALS in spinal cord injury. We will be looking at secondary endpoints as well, by which we hope to measure some degree of functional recovery.

                            As in the ALS trial, we are proposing to transplant patients with injuries in the thoracic (mid-back) regions first. Once the safety of the surgeries has been established, we plan to transplant patients whose injuries are in the cervical (upper spinal cord) region."

                            Potential Mechanism of Therapeutic Action


                            Clinical studies with chronic SCI patients have demonstrated that, even several years after motor- and sensory-complete SCI, intensive and task-specific rehabilitation can improve motor function as measured by the ASIA Impairment Scale (AIS). These clinical experiences, together with results from numerous animal studies of SCI, illustrate that even the complete, chronically-injured cord can undergo some degree of recovery and reorganization. Transplantation of Neuralstem's human spinal stem cells (HSSC) is meant to provide a neuron-rich substrate to the injured segments of a patient's spinal cord to promote further repair, regeneration, and reorganization. The goal is to harness this inherent plasticity and promote reorganization by combining stem cell transplantation with the modern concept of activity-guided rehabilitation.
                            Currently, no predictive animal model of chronic human SCI exists. However, in a rat model of ischemia-induced spinal cord injury that generates the condition of permanent paraplegia, transplantation of Neuralstem's HSSC into the injury site leads to significant motor recovery (reported in NEUROSCIENCE, June 29, 2007, in conjunction with the University of California at San Diego). Detailed analysis revealed robust graft survival, extensive neuronal differentiation, and integration of grafted cells into the host circuitry, all outcomes which we believe are essential for recovery of function in human patients. Similar results were obtained by Neuralstem in rodent models of ALS in which transplanted HSSC again showed extensive neuronal differentiation and integration with host neuronal circuitry, and led to the rescue of at-risk motor neuron populations (reported in Transplantation, October, 2006, and Journal of Comparative Neurology, March 2009, in conjunction with Johns Hopkins University). These studies further demonstrated that Neuralstem's HSSC transplants secreted important neuroprotective agents and extended long-distance axons into the host.
                            Neuralstem believes that, in chronic SCI, our HSSC transplants may promote reorganization of segmental circuitry over the long-term. In the cervical region of the spinal cord, this could result in improved breathing capacity and recovery of sensori-motor functions of the upper limbs. Segmental reorganization induced by, and utilizing graft-derived neurons, may also result in improved locomotion.
                            Neurons differentiated from Neuralstem's HSSC grafts in chronic thoracic injuries may serve as a bridge to connect the axons located above the site of injury to neurons of segments below the injury site. HSSC grafts may also encourage axons to regenerate through the graft to segments below the injury.
                            ###



                            About Chronic Spinal Cord Injury There are more than 10,000 new spinal cord injuries (SCI) in the US each year. At the time of a recent survey done by the Christopher & Dana Reeve Foundation, there were approximately 840,000 people living with chronic SCI. According to the National Spinal Cord Injury Association, 85% of SCI patients who survive the first 24 hours are still alive 10 years later.

                            About Neuralstem
                            Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in a Phase I safety clinical trial for Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig's disease. The company is also targeting major central nervous system diseases in addition to ALS, including traumatic spinal cord injury, ischemic spastic paraplegia, and Huntington's disease. The company has also submitted an IND application to the FDA for a Phase I safety trial in chronic spinal cord injury. Through its proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company plans to initiate clinical trials to treat Alzheimer's disease and major depression with its lead compound, as well as pursue additional indications, including traumatic brain injury, posttraumatic stress syndrome, stroke and schizophrenia.
                            http://www.eurekalert.org/pub_releas...-nff082510.php
                            http://spinalcordresearchandadvocacy.wordpress.com/

                            Comment


                              #15
                              Originally posted by GRAMMY View Post
                              I am anxious to see them move forward!
                              Grammy, thanks for taking the time to provide us with all the informative info.

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