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Thread: Possible opportunity

  1. #21
    Quote Originally Posted by Pauly1 View Post
    Contacted Dr. Kim on Facebook for a quote and overview of services. He wants US$60k, placing him on the premium end of the market for what is the most legit SCI stem cell therapy. Compare then Puhua & Wumedical in China want 25k and 30k respectively using neural stem cells. Panama is in the 35k range.

    Here's Dr. Kim reply on Facebook

    Has he done clinical trials?

  2. #22
    Jim, according to http://www.pharmicell.com/eng/pr/rep...l.html?seq=100, yes:

    Pharmicell proves the ‘effectiveness’ of stem cell therapy for spinal cord injury

    Stronger effects are shown with multiple dosing

    The promising research findings for patients with spinal cord injury (SCI) introduced in an international journal are drawing a big attention from the academic community.

    Pharmicell(005690) unveiled its findings on 29th that studies on the effects of Cellgram-SCI, stem cell therapeutics, to treat patients with spinal cord injury suggest that multiple dosing is much more effective than single dose use.

    Prof. Jeon Sang Yong of Seoul Asan Medical Center and his team have been using ‘Cellgram-SCI produced by Pharmicell to treat paralyzed patients on clinical trials and revealed their findings on the latest edition of the Journal of ‘Neurosurgery’, the official journal of the AANS (American Association of Neurological Surgeons).

    This is the second time that Jeon and his team presented treatment effects proven by clinical research using ‘Cellgram-SCI’ in the journal since 2012. In the previous clinical study, the Cellgram was injected into patients’ body three times but this time only one single dose was applied.

    Two rounds of clinical trials indicate that multiple dosing is way better than single dosing to improve the conditions of tetraplegia patients damaged by chronic spinal cord injury in the kinematic and neurological context,” said Jeon


    He more added, “Yet, MRI/DTI test results of some patients with improved conditions despite single dose of stem cell therapy injection show fiber continuity on the injured parts their spinal cord which was non-existent before the treatment, and that implies neural regeneration led by the stem cell therapy.”

    “Since regenerative ability of nerve cells is limited, stem cell-based therapies are desperately needed,” said Kim, Hyeon-Soo, head of Pharmicell. “These encouraging results from the trial will give a hope to patients suffering from incurable diseases including paralyzed patients damaged by spinal cord injury.”
    Last edited by Pauly1; 09-13-2017 at 09:34 AM.

  3. #23
    Quote Originally Posted by Jim View Post
    Has he done clinical trials?
    I'm not finding any publication with actual trial results yet.

  4. #24
    Grammy, from http://celltrials.info/2017/01/02/ce...year-review-2/ I found:

    Big failures of clinical trials
    .. Third, South Korean Phase 3 clinical trial, assessing efficacy if autologous bone marrow-derived mesenchymal stem cells in patients with chronic spinal cord injury was terminated in the middle due to futility. Only 2 patients out of 16 analyzed showed functional improvement. The study was supported by company Pharmicell.
    Looked back to 2016 and found the linked article on webarchive, the abstract being:

    Abstract

    BACKGROUND:

    In our previous report, 3 of 10 patients with spinal cord injury who were injected with autologous mesenchymal stem cells (MSCs) showed motor improvement in the upper extremities and in activities of daily living.

    OBJECTIVE:
    To report on the results of a phase III clinical trial of autologous MSCs therapy.
    METHODS:
    Patients were selected based on the following criteria: chronic American Spinal Injury Association B status patients who had more than 12 months of cervical injury, and no neurological changes during the recent 3 months of vigorous rehabilitation. We injected 1.6 ? 107 autologous MSCs into the intramedullary area at the injured level and 3.2 ? 107 autologous MSCs into the subdural space. Outcome data were collected over 6 months regarding neurological examination, magnetic resonance imaging with diffusion tensor imaging, and electrophysiological analyses.

    RESULTS:
    Among the 16 patients, only 2 showed improvement in neurological status (unilateral right C8 segment from grade 1 to grade 3 in 1 patient and bilateral C6 from grade 3 to grade 4 and unilateral right C8 from grade 0 to grade 1 in 1 patient). Both patients with neurological improvement showed the appearance of continuity in the spinal cord tract by diffusion tensor imaging. There were no adverse effects associated with MSCs injection.
    CONCLUSION:

    Single MSCs application to intramedullary and intradural space is safe, but has a very weak therapeutic effect compared with multiple MSCs injection. Further clinical trials to enhance the effect of MSCs injection are necessary.

    The full text in the webarchive article goes into significant depth on how the MSC stem cells were cultivated and the method used for injection at the injury site.

    We see they found that multiple injections of the MSC stem cells yield better results.

  5. #25
    Senior Member lunasicc42's Avatar
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    so is it essentially a NothingBurger with very modest results... I am interpreting mixed signals
    "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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  6. #26
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    Waiting is better

  7. #27
    Quote Originally Posted by Jawaid View Post
    Waiting is better
    Yup. Found 2 recent articles citing Pharmicell's MSC cell as still under clinical trials and emerging tech.

    Sep-2017: Translational Advances in the Management of Acute Spinal Cord Injury: What is New? What is Hot?
    Mar-2017: Traumatic Spinal Cord Injury—Repair and Regeneration

    Though if you have US$60k deep pockets and are OK with some improvements then Pharmicell has a history of SCI-related research and (likely) Dr.Kim is qualified to implant those MSC stem cells.
    Last edited by Pauly1; 09-13-2017 at 02:57 PM.

  8. #28
    Quote Originally Posted by lunasicc42 View Post
    so is it essentially a NothingBurger with very modest results... I am interpreting mixed signals

    Big failures of clinical trials

    Third, South Korean Phase 3 clinical trial, assessing efficacy if autologous bone marrow-derived mesenchymal stem cells in patients with chronic spinal cord injury was terminated in the middle due to futility. Only 2 patients out of 16 analyzed showed functional improvement. The study was supported by company Pharmicell.

    (The phase 3 was terminated for lack of efficacy in chronic SCI). I wouldn't pay $60,000 for a therapy that couldn't cut the mustard in a trial. This is why clinical trials take place to begin with. It protects the patients from paying money for treatments that will probably only lighten their wallets as opposed to helping them. No is NO. The Signal: "terminated/failure"

    Last edited by GRAMMY; 09-13-2017 at 06:02 PM.

  9. #29
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by GRAMMY View Post
    Big failures of clinical trials

    Third, South Korean Phase 3 clinical trial, assessing efficacy if autologous bone marrow-derived mesenchymal stem cells in patients with chronic spinal cord injury was terminated in the middle due to futility. Only 2 patients out of 16 analyzed showed functional improvement. The study was supported by company Pharmicell.

    (The phase 3 was terminated for lack of efficacy in chronic SCI). I wouldn't pay $60,000 for a therapy that couldn't cut the mustard in a trial. This is why clinical trials take place to begin with. It protects the patients from paying money for treatments that will probably only lighten their wallets as opposed to helping them. No is NO.


    Boo.
    "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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  10. #30
    Grammy, they are reporting progress with different dosages:

    2012: 3 of 10 patients with spinal cord injury who were injected with autologous mesenchymal stem cells (MSCs) showed motor improvement in the upper extremities and in activities of daily living.
    dosage: 4 ? 10 cells were injected into the intradural space of 10 patients with American Spinal Injury Association class A or B injury caused by traumatic cervical SCI. After 4 and 8 weeks, an additional 5 ? 10 MSCs were injected into each patient through lumbar tapping.

    2016: Single MSCs application to intramedullary and intradural space is safe, but has a very weak therapeutic effect compared with multiple MSCs injection. Further clinical trials to enhance the effect of MSCs injection are necessary.
    Dosage: We injected 1.6 ? 107 autologous MSCs into the intramedullary area at the injured level and 3.2 ? 107 autologous MSCs into the subdural space.

    2020: we wait for their progress report with higher dose.

    Commercially Dr. Kim advised (and priced) 3 doses of the US$20k cellgram MSC stem cells which appears to take into consideration that a single dose was inadequate.

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