Page 2 of 2 FirstFirst 12
Results 11 to 20 of 20

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

  1. #11
    Quote 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!

  2. #12
    Quote 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; 07-12-2011 at 03:32 PM.

  3. #13
    Senior Member lunasicc42's Avatar
    Join Date
    Oct 2004
    Location
    Lutz, Fl USA*********C456
    Posts
    2,305
    @ 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

  4. #14
    Quote 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

  5. #15
    Quote 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.

  6. #16
    You are welcomed Patty. I'm happy you stay interested in the progress towards a cure. I always enjoy your sweet posts.

  7. #17
    Senior Member
    Join Date
    May 2005
    Location
    Pakistan
    Posts
    1,168
    Thank you dear Grammy for all detailed info.

    Things are bit discouraging for old and lower injuries but we have to keep waiting.

    Neuralstem and Stemcell Inc will be treating chronic lower injuries but i guess still wait of 2 to 3 years.

    Grammy something should be done regarding criteria of the trials. Lower injuries should be included in the trials. Need to push Ethic Committees. If they say chronics they should be chronics no matter of how much old injury is.

  8. #18
    Senior Member tarheelandy's Avatar
    Join Date
    Jan 2008
    Location
    Athens, Ga
    Posts
    545
    Blog Entries
    2
    I had actually bought Geron stock and sold it to buy "Cur" when they announced the ALS trial. As far as I know, they have not taken seed money from a big pharma like Geron has from Merck. I am not at all opposed to that , I just like the fact that Mr. Garr can follow his own agenda......

  9. #19
    Has anyone read the blog by Tory Minus Head in the clouds?

  10. #20
    Quote Originally Posted by fanette32 View Post
    Has anyone read the blog by Tory Minus Head in the clouds?
    Yes. We're all watching T.J. with baited breath and sincerely hope his stem cells from Geron work for him. He is a brave soul and has decided to advocate heavily for stem cell research and regenerative medicine. Wish him the best!

Similar Threads

  1. Replies: 1
    Last Post: 11-28-2010, 05:02 AM
  2. Replies: 42
    Last Post: 01-22-2007, 09:11 PM
  3. Key info about the China Human Clinical Trial Network
    By Corinne Jeanmaire in forum Cure
    Replies: 0
    Last Post: 12-03-2006, 01:36 PM
  4. HUMAN CLINICAL TRIAL IN JAPAN
    By manouli in forum Cure
    Replies: 4
    Last Post: 12-10-2004, 05:32 AM
  5. VA Medical Center Probed on Clinical Trial Deaths
    By antiquity in forum Health & Science News
    Replies: 0
    Last Post: 02-06-2003, 07:56 PM

Posting Permissions

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