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Thread: Clinical Trials

  1. #541
    Dr. Young,
    Hi, I hope you are doing well. One question regarding the sites of cells injection , (sorry if you have answered it somewhere else) . You indicated that for those 41 subjects that they have received the cells transplants , you injected one injection above the injury site , and one injection below the injury site ; my question is :For those 41 subjects , was there any reason that you did not inject one injection INTO THE SITE OF INJURY in addition to those above and below the injury site? Do you think the outcome would be different if you inject three injections instead of two , one injection above the injury site , one injection into the injury site, and one injection below the injury site ? I always thought that the site of injury is where it needs most of the help that it can get in addition to the above and the below the injury sites.
    Thanks for your time and reply , and have a fantastic day.
    Last edited by kz; 08-22-2012 at 08:11 AM.

  2. #542
    Quote Originally Posted by kz View Post
    Dr. Young,
    Hi, I hope you are doing well. One question regarding the sites of cells injection , (sorry if you have answered it somewhere else) . You indicated that for those 41 subjects that they have received the cells transplants , you injected one injection above the injury site , and one injection below the injury site ; my question is :For those 41 subjects , was there any reason that you did not inject one injection INTO THE SITE OF INJURY in addition to those above and below the injury site? Do you think the outcome would be different if you inject three injections instead of two , one injection above the injury site , one injection into the injury site, and one injection below the injury site ? I always thought that the site of injury is where it needs most of the help that it can get in addition to the above and the below the injury sites.
    Thanks for your time and reply , and have a fantastic day.
    kz, I thought that I answered your question but it seems that I did not. There are several reasons that we did not inject into the injury site. First, the injury site is often quite thin. We are using a needle with a 2 mm bevel and the injury site may be 3-4 mm thick. So, it is easy to poke the needle all the way through or part of the bevel may stick out of the spinal cord and therefore the cells will leak out. Second, when we have injected cells into the middle of the injury site, we often see an island of cells separated from the surrounding tissues by a desert. However, when we inject into the surrounding cord, we often see the cells migrate into the injury site and form a bridge across the injury site.

    By the way, we make 4 injections into the spinal, one on each side (left and right) of the spinal cord above the injury site and one on each side (left and right) of the spinal cord below the injury site.

    Wise.

  3. #543
    Junior Member
    Join Date
    Sep 2012
    Location
    West Chester, PA
    Posts
    8
    Dr. Young,

    Pleasure to be able to post on this site, thank you. Forgive me if this was answered already, I searched through the threads as best I could.

    I have tried to make it to the open house dates at Rutgers, but couldn't make it due to travel schedules. I very much want to introduce myself to you and your team.

    I have what has been diagnosed as ADEM or Transverse Myelitis. Major area of damage is T4-T8. I have recovered to the point of using crutches, but can not make further progress in 2 years. My damage is in a discreet area, and not progressing any further as shown in multiple MRIs in the last 2 years.

    Would I make a good candidate in future trials to show repair of my myelin? I would very much like to consult with your team on my condition to see if my case would be of interest.

    I would travel to Rutgers at your convenience. It is about a 2 hour drive for me, so I will gladly do that if you or your team can make the time.

    Regards,

    John
    Last edited by JohnJH1; 09-27-2012 at 01:45 PM.

  4. #544
    John,

    To date, we have not stipulated in our ChinaSCINet phase I and II trials that the cause of the spinal cord injury, allowing the surgeons to make the decision, as long as the lesion is restricted to less than 3 segments and the subject is an AIS A classfication. To date, we have not had (to my knowledge) any case that is due to transverse myelitis (TM).

    I think that we are likely to restrict the diagnosis to traumatic spinal cord injury in our upcoming phase III trials in China, U.S., and Norway. The reasons are as follows. ADEM cases that are restricted to the spinal cord can be considered TM. However, many causes of TM are not due to ADEM and ADEM often involve the brain. Finally, ADEM has a autoimmune component.

    It would be great of course if you could come to the Open Houses. I try my best to hold one on the first Friday of every month. We are having one this coming Friday, as well as November 2. If you come, I can adjust my review of spinal cord injury therapies to cover treatments for TM.

    If it turns out that umbilical cord blood mononuclear cells and lithium are effective for spinal cord injury, I think that we (or some other group) will initiate a clinical trial for those with TM. In my opinion, the therapies for regenerating spinal cord should also be effective for TM.

    Wise.











    Quote Originally Posted by JohnJH1 View Post
    Dr. Young,

    Pleasure to be able to post on this site, thank you. Forgive me if this was answered already, I searched through the threads as best I could.

    I have tried to make it to the open house dates at Rutgers, but couldn't make it due to travel schedules. I very much want to introduce myself to you and your team.

    I have what has been diagnosed as ADEM or Transverse Myelitis. Major area of damage is T4-T8. I have recovered to the point of using crutches, but can not make further progress in 2 years. My damage is in a discreet area, and not progressing any further as shown in multiple MRIs in the last 2 years.

    Would I make a good candidate in future trials to show repair of my myelin? I would very much like to consult with your team on my condition to see if my case would be of interest.

    I would travel to Rutgers at your convenience. It is about a 2 hour drive for me, so I will gladly do that if you or your team can make the time.

    Regards,

    John

  5. #545

    lithium orotate

    Wise, have you ever considered using the natural, safer form of lithium in your trials? I've been supplementing with lithium orotate for years now and yet it's a very small amount. Maybe a large amount would be more effective in healing the damaged spinal cord? Thanks!

    Jan

  6. #546

    InVivo Therapeutics Requests Humanitarian Use Device Designation with FDA

    http://investorstemcell.com/featured...tion-with-fda/

    CAMBRIDGE, Mass. (December 14, 2012) – InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced that the Company has filed a request with the U.S. Food and Drug Administration (FDA) for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product. InVivo is currently working with the FDA on the final steps to seek approval to begin a clinical trial of the scaffolding in acute SCI in early 2013.

    Devices eligible for HUD designation are developed to treat rare diseases or conditions. InVivo has requested designation for the use of its biopolymer scaffolding in the treatment of complete functional spinal cord injuries that do not involve penetrating injury or the complete severing of the spinal cord.

    The request comes after an April 2012 meeting in which InVivo and the FDA discussed the requirements for the HUD designation and the potential for the device to be regulated and distributed under a Humanitarian Device Exemption (HDE). An HUD designation and a subsequent approved Humanitarian Device Exemption (HDE) would enable InVivo to commercialize the devices in the United States faster than the Pre-Market (PMA) approval process.

    Said InVivo Director of Regulatory Affairs Jack Bonasera, “The HUD/HDE provision provides a pathway for obtaining market approval from FDA for medical devices that may help people with rare diseases or conditions that otherwise would be remain unmet. InVivo is confident that the results of well designed pre-clinical studies will satisfy the primary HDE requirements in this type of devastating injury where no motor or sensory function is present below the level of neurological injury.”

    “HUD designation is not only important for speed-to-market but also represents a benchmark in InVivo’s commitment to patients with spinal cord injuries and other neurotrauma conditions. Our GMP team is ready to go, and our clean room is humming. We expect 2013 to be a breakout year for InVivo stakeholders as we advance additional products into the FDA process,” said Frank Reynolds, InVivo Chief Executive Officer.

    The Company expects to receive feedback from the FDA on the HUD request in January 2013.

    About InVivo Therapeutics

    InVivo Therapeutics Holdings Corp. is utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed from traumatic spinal cord injuries. The company was founded in 2005 based on proprietary technology co-invented by Robert S. Langer, ScD. Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital. In 2011, the company earned the prestigious 2011 David F. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

    Safe Harbor Statement
    Certain statements contained in this press release that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934, and the Company intends that such statements are subject to the safe harbor created thereby. These statements include, but are not limited to, those relating to the expected approval of the FDA to conduct human clinical trials for the Company’s products, the expected commencement date of any approved human clinical trials, the expected size of the pilot study, the expectation that the scaffold product will be regulated under a HDE pathway, and the expected acceleration of commercialization of the Company’s products resulting therefrom. These forward-looking statements are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to obtain FDA approval to conduct human clinical trials; whether the human clinical trials produce acceptable results; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our Annual Report on Form 10-K for the year ended December 31, 2011 and subsequent filings with the SEC.
    Forward-looking statements contained in this press release speak only as of the date of this release. Subsequent events or circumstances occurring after such date may render these statements incomplete or out of date. The Company undertakes no obligation and expressly disclaims any duty to update such statements.
    "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---->

  7. #547
    Quote Originally Posted by FellowHawkeye View Post
    Wise, have you ever considered using the natural, safer form of lithium in your trials? I've been supplementing with lithium orotate for years now and yet it's a very small amount. Maybe a large amount would be more effective in healing the damaged spinal cord? Thanks!

    Jan
    Hi, Jan. To my knowledge, lithium carbonate is very safe, the most common "natural" form of the mineral, and more used and studied than any other form of lithium. I don't think that the anion is all that important. Other forms of lithium that are approved and available include lithium chloride, lithium carbonate, and lithium sulfate. I don't know or think that there are large differences in bioavailability between the chloride, carbonate, and sulfate salts. However, I don't know about orotate.

    Wise.

  8. #548

    World’s 1st Human Embryonic Stem Cell Trial for Spinal Cord Injury – Katie Sharify’s

    World’s 1st Human Embryonic Stem Cell Trial for Spinal Cord Injury – Katie Sharify’s Story

    Published on Nov 28, 2012

    Katie Sharify was one of five people with spinal cord injuries to participate in the world's first clinical trial testing human embryonic stem cells. The Geron sponsored trial was supported by California's Stem Cell Agency (CIRM). In this video Katie speaks about her clinical trial experience with a group of scientists who were meeting to discuss the best ways of advancing stem cell clinical trials. CIRM communications manager Amy Adams interviewed Katie and her doctor, Stephen McKenna.

    To learn more about the efforts of California's Stem Cell Agency (CIRM) to accelerate the development of new therapies for chronic disease and injury, visit our home page at: California Institute for Regenerative Medicine
    For more information about CIRM-funded spinal cord injury research, visit our fact sheet: Spinal Cord Injury Fact Sheet | California Institute for Regenerative Medicine
    Category
    Science & Technology
    License
    Standard YouTube License



    http://www.spinalcordinjuryzone.com/...sharifys-story
    "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---->

  9. #549

    InVivo Therapeutics Submits Updated IDE to FDA to Begin Spinal Cord Injury Human Stud

    http://investorstemcell.com/stem-cel...y-human-study/

    InVivo Therapeutics Submits Updated IDE to FDA to Begin Spinal Cord Injury Human Study - See more at: http://investorstemcell.com/stem-cel....TmApl3Sm.dpuf

    02/28 06:00 AM
    CAMBRIDGE, Mass.–(BUSINESS WIRE)– InVivo Therapeutics Holdings Corp. (NVIV:$1.92,00$0.11,006.08%) , a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced the Company has submitted an updated Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) requesting permission to begin human studies in order to test its biopolymer scaffolding for the treatment of acute SCI.
    The updated IDE submission is in response to exchanges since InVivo’s April 12, 2012 meeting with the FDA. The filing contains additional information regarding the manufacturing and pre-clinical testing of the scaffolding device. Once approved, the IDE will allow InVivo to conduct an open-label human study to collect safety and efficacy data to support FDA approval of the first in-cord treatment for SCI. The Company is also working with the FDA in order to have the scaffolding device designated as a Humanitarian Use Device (HUD), a designation that InVivo expects will create a faster path to market.
    “We are prepared to safely treat acute SCI patients, and in the coming months we hope to have the first opportunity to translate to humans the positive effect from the scaffold that we observed in our 2008, 2009, and 2011 non-human primate studies,” said Frank Reynolds, InVivo Chief Executive Officer. “Our technology remains the only treatment to have demonstrated functional recovery when applied to non-human primates with SCI, and this first study has the potential to change the treatment options for neurotrauma patients forever.
    “We’ve all heard that ‘an ounce of prevention is worth a pound of cure,’ and over a hundred people on the InVivo team have worked tirelessly since 2008 to bring this ‘ounce of prevention’ to patients. We intend to intervene shortly after injury to minimize the advancement of scarring and to provide functional recovery within weeks of treatment.” Continued Reynolds, “I want to thank our Chief Medical Officer, Dr. Eric Woodard, and our Chief Technology Officer, Brian Hess, along with their teams, for their deep and never ending commitment to SCI patients. We look forward to receiving feedback from the FDA and to getting started on this historical first-in-man clinical trial.”
    Said Brian Hess, InVivo Chief Technology Officer, “We appreciate the collaborative dialogue we have had with the FDA. Since our April 2012 meeting, we’ve established regulatory processes to treat neurotrauma with biomaterials, and we’ve completed knowledge transfer with the FDA that we believe will benefit all of our additional products in development. We expect to bring a wide range of neurotrauma treatments to patients as quickly as possible with the potential for two new 510(k) products to hit the market in late 2014. In addition to the scaffolding device for SCI, we are developing products for conditions such as pain, fibrosis, and drug delivery, and we continue to make excellent progress in these applications as well.”
    About InVivo Therapeutics (NVIV:$1.92,00$0.11,006.08%)
    InVivo Therapeutics Holdings Corp. (NVIV:$1.92,00$0.11,006.08%) is utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed from traumatic spinal cord injuries. The company was founded in 2005 based on proprietary technology co-invented by Robert S. Langer, ScD. Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital. In 2011, the company earned the prestigious David F. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
    Safe Harbor Statement
    Certain statements contained in this press release that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934, and the Company intends that such statements are subject to the safe harbor created thereby. These statements include, but are not limited to, those relating to the expected approval of the FDA to conduct human clinical trials for the Company’s products, the expected commencement date of any approved human clinical trials, the expected size of the pilot study, the expectation that the scaffold product will be regulated under a HDE pathway, and the expected acceleration of commercialization of the Company’s products resulting therefrom. These forward-looking statements are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to obtain FDA approval to conduct human clinical trials; whether the human clinical trials produce acceptable results; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our Annual Report on Form 10-K for the year ended December 31, 2011 and subsequent filings with the SEC.
    Forward-looking statements contained in this press release speak only as of the date of this release. Subsequent events or circumstances occurring after such date may render these statements incomplete or out of date. The Company undertakes no obligation and expressly disclaims any duty to update such statements.
    Source: InVivo Therapeutics Holdings Corp. (NVIV:$1.92,00$0.11,006.08%)
    - See more at: http://investorstemcell.com/stem-cel....TmApl3Sm.dpuf
    "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---->

  10. #550
    Junior Member
    Join Date
    Sep 2012
    Location
    West Chester, PA
    Posts
    8
    Quote Originally Posted by Wise Young View Post
    John,

    To date, we have not stipulated in our ChinaSCINet phase I and II trials that the cause of the spinal cord injury, allowing the surgeons to make the decision, as long as the lesion is restricted to less than 3 segments and the subject is an AIS A classfication. To date, we have not had (to my knowledge) any case that is due to transverse myelitis (TM).

    I think that we are likely to restrict the diagnosis to traumatic spinal cord injury in our upcoming phase III trials in China, U.S., and Norway. The reasons are as follows. ADEM cases that are restricted to the spinal cord can be considered TM. However, many causes of TM are not due to ADEM and ADEM often involve the brain. Finally, ADEM has a autoimmune component.

    It would be great of course if you could come to the Open Houses. I try my best to hold one on the first Friday of every month. We are having one this coming Friday, as well as November 2. If you come, I can adjust my review of spinal cord injury therapies to cover treatments for TM.

    If it turns out that umbilical cord blood mononuclear cells and lithium are effective for spinal cord injury, I think that we (or some other group) will initiate a clinical trial for those with TM. In my opinion, the therapies for regenerating spinal cord should also be effective for TM.

    Wise.
    Dr. Young,

    Thank you for your engagement in this cause, it gives many of us hope.

    It has been hard for me to get to Rutgers for the Open Houses. Dr. Morton and I have exchanged a few emails about this and I let her know I would confirm when I could make the trip ahead of time. It would be great to learn about any therapies or trials that could look at TM in the future.

    If there is any information that would help explain my diagnosis I could get that from my neurologist. Dr. Morton has my contact information.

    Thank you again. I look forward to attending one of the sessions.

    John Hess

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