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Thread: Spinal Cord Injury Network USA (SCINetUSA)

  1. #161
    Jim I was thinking along the lines of how far S.C.I. has come from no hope to getting hope through donations and to see the doctors and researchers explaining the trials lay man terms and showing some patience getting work done and results you hope to get and please do not show a video of happy S.C.I. playing and talking that life is not so bad and saying that this will not get the better of us well i hope not would the researchers not have some animals walking etc. you could explain and show what evidence hoping that the trials will work if you were to put a video on what would it be I pm you my hot mail for a news letter.

  2. #162
    Quote Originally Posted by Chaz19 View Post
    <snip.
    I guess I'm also confused on why a trial needs to involve many centers in order for it to be properly quantified. I think my confusion is based upon the fact that Geron is conducting such a small pilot study. For some reason my mind thinks that smaller would be faster, but I'm well aware of the fact that I don't have a strong understanding of the clinical trial process. Any thoughts?
    The Geron is a phase one for safety only. Ten patients and seven centers. If a center consents a patient and performs the procedure then they have to wait 30 days before they can enroll their second patient. The only apparent rational is to spread the patients across all centers. The proocols, consent and exclusions are far beyond what the Procord macrophage study required. If it proves safe then phase two will have a larger number of patients.

  3. #163
    Super Moderator Sue Pendleton's Avatar
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    This is what I meant Wise. I've seen the side effects of lithium even when there is no toxicity. That it is still the most effective drug going for classic manic/depression says a lot for it though when used under supervision.

    I would think that there are people on lithium with spinal cord injuries just by the number of people on it for mental illness. Some people must overlap. How soon can you expect an answer in the China trials on whether lithium improves function in chronic SCI?

    And just so my PMs do not fill up. I will not be trying lithium until I hear it works in the China trials. So ask your own doctors for information.

    Sue

    I did get a note on the name change. Needed that before talking to someone.
    Quote Originally Posted by Wise Young View Post
    I of course know that you are not suggesting that people take lithium. On the other hand, there are spinal-injured people who are already taking lithium. Let me take the opportunity to discuss lithium toxicity:
    Treatment of manic depression. For treatment of manic depression, a serum of level of 0.6-1.0 millimolar (mM) is recommended. We are assuming that the same levels that are beneficial for manic depression would be beneficial for spinal cord injury.
    Toxic levels. Serum levels of 1.6 mM or higher are considered to be toxic. By the way, for older people, toxicity has been reported at 1.0 mM or lower.
    Titration. Because the effective dose range is so close to the toxic does, it is necessary to titrate the dose in each person by testing serum levels of the drug. In our phase 1 clinical trial, people started with 250 mg bid (twice a day or 500 mg per day) and are tested 3 days later for serum levels. If the serum lithium levels are over 0.6 mM and less than 1.0 mM, we keep them on that. If the levels are less that 0.6 mM, we go to 250 mg tid (thrice a day, or 750 mg/day) and test three days later. If the serum levels are 0.6-1.0 mM, we stay at that dose. If it exceeds 1.0 mM, we drop back the dose. If it is less than 0.6 mM, we go to 500 mg bid (i.e. 1000 mg per day)... and so on.
    Toxicity. The main toxicity that we are worried about is brain damage. This usually occurs when lithium levels are greater than 1.6 mM for long periods (i.e. months). Kidney toxicity can occur but we have not seen it so far in people with chronic spinal cord injury that have been treated for 6 weeks. We were also worried about lithium aggravating neuropathic pain but so far we have not seen this either.

    In our experience, the dose of lithium required to achieve and maintain 0.6-1.0 mM levels of serum lithium varies greatly in people with spinal cord injury. Some people reach the target level with only 250 mg tid (i.e. 750 mg/day) and some people require as much as 500 mg tid (i.e. 1500 mg/day). While body weight is a predictor of the final dose that is necessary, it is not a good predictor because the main way that lithium is eliminated is excretion by the kidney. This clearance of lithium also depends on how much fluid a person drinks and their kidney function.

    In the United States, I have heard that manic depression affects about 3% of the population and about half of people who have manic depression take lithium. If true, this suggests that as many 4 million people in the United States are taking lithium. Many people have taken lithium for a lifetime. So, for people who tolerate lithium, it appears to be a safe drug. But, because toxicity levels are close to therapeutic levels, it must be administered by a doctor who is experienced with lithium and can titrate the dose.

    Lithium can cause kidney damage but this is often under special circumstances (Source):
    • Hyponatremia (low serum sodium)
    • Volume depleted (low fluid intake)
    • Low glomerular filtration rate (older people)

    Please note that about 10,000 people per year are admitted to hospital with lithium toxicity because the population of patients who take lithium may not be taking the drug correctly. Of these, about 20% involve moderate to severe toxicity with central nervous system damage and cardiovascular collapse. So, this is not an innocuous drug.

    Drugs that inhibit tubular reabsorption (such as aminophylline and carbonic anhydrase inhibitors) may increase renal secretion of lithium, therefore leading to a higher dose of lithium required to maintain serum levels of 0.6 to 1.0 mM. However, if the patient were to stop these drugs while taking lithium, the levels of serum lithium may rise to toxic levels.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  4. #164
    Quote Originally Posted by c473s View Post
    The Geron is a phase one for safety only. Ten patients and seven centers. If a center consents a patient and performs the procedure then they have to wait 30 days before they can enroll their second patient. The only apparent rational is to spread the patients across all centers. The proocols, consent and exclusions are far beyond what the Procord macrophage study required. If it proves safe then phase two will have a larger number of patients.
    Ok, so if seven center are used, seven patients will be treated roughly at the same time. After 30 days, then three more patients will be chosen for the safety study?

  5. #165
    Quote Originally Posted by Jim View Post
    Chuck,

    Donors will automatically be added to the mailing list and therefore will receive the eNewsletter. If they don't want to receive it, they will have that option also.

    skeaman & chaz,

    What specifically did you have in mind for the video?
    here are some scattered thoughts:
    • a layman introduction to the history of spinal cord injury research
    • an explanation of China SCINET and current status of lithium clinical trials
    • an animated or 3-D segment providing an image of what the therapy entails ( explained theory)
    • how does SCI affect people section?
    • how much money is needed? (Where are we now?)
    • examples of how the people can raise money
    • explaining short-term goals and providing updates quarterly/annually to keep people in the loop. How do you make a video, text, photos feel "real" or tangible to an average citizen. I'm not sure, but im sure an advertising or marketing agent would have ideas.
    • why fund SCI research when there are so many other causes?

  6. #166
    Chaz19,

    I listened in to this webinar and then downloaded this pdf. It's a lot of information all at once, but it answered questions I didn't even know I had. I think this is so helpful, and this way Dr. Young doesn't have to repeat himself again and again.

    Here's the webinar.
    http://www.thisabled.com/stem-cell-webinar.php


    Here's the pdf slideshow that went with it, updated, so they can be seen well.
    http://www.thisabled.com/StemCellWebinar.pdf

    I think that would answer your request for layman's history and for updated info on stem cell trials.

    --Flame carcanet

  7. #167
    Quote Originally Posted by skeaman View Post
    Jim I was thinking along the lines of how far S.C.I. has come from no hope to getting hope through donations and to see the doctors and researchers explaining the trials lay man terms and showing some patience getting work done and results you hope to get and please do not show a video of happy S.C.I. playing and talking that life is not so bad and saying that this will not get the better of us well i hope not would the researchers not have some animals walking etc. you could explain and show what evidence hoping that the trials will work if you were to put a video on what would it be I pm you my hot mail for a news letter.
    skeaman,

    I don't feel comfortable showing videos of walking rats or patients, even though I have both. The reason is because rats and people may be walking for reasons other than the treatment. It is always easy to select one example and it is human to think that everybody will respond like the example. Please understand that I am not against companies showing ads with beautiful smiling people using their products. That is marketing. I don't believe that it is a good idea to market experimental therapies that are on clinical trial. I also think that it is not a good idea to give numbers like 70% recovery of rats because the relationship of animal recovery to human recovery is tenuous and depends on both injury type and severity.

    On the other hand, I think that it is important that people know that animal studies have shown that the proposed therapy is beneficial in animals, that they are aware of the information concerning safety of the therapy, and they understand rationale for testing the therapy. There is no guarantee of treatment effect or safety. Participating in a clinical trial is a service that people are performing for the community. People are taking a risk on behalf of other people with spinal cord injury. An experimental therapy means that there is not yet convincing data indicating efficacy. They are taking the risk in order to help accelerate the development of therapies for spinal cord injury. That is why the clinical trial does not charge for the therapy. If the therapy works, that is great. If it doesn't work, we need to go on to something else and not waste valuable resources on something that is not safe or effective.

    In the case of umbilical cord blood and lithium, there is data from animal studies indicating that mononuclear cells alone and lithium alone are beneficial in spinal cord injury. We hypothesize that the combination of the two treatment would be better than each one alone. That is why the trial will test each of the therapy alone and the two therapies together. In order to ensure the highest likelihood of showing a significant treatment effect, we chose certain inclusion and exclusion criteria that would ensure that the patients have similar injuries. The greater the variability of people in each treatment group, the more subjects we will need to show a significant difference.

    The injury type and level also determines which outcome measures can be used. For example, if the study includes people with cervical and thoracic spinal cord injury, we must use an outcome measure that can be applied to both. Obviously, we cannot compare arm function in people with cervical and thoracic spinal cord injuries because the latter will not be affected by the injury. On the other hand, changes in motor and sensory scores are valid for both cervical and thoracic spinal cord injury. Likewise, comparison of walking scores may also be valid because both cervical and thoracic spinal cord injury cause impairment of walking.

    Safety considerations play a role in the inclusion and exclusion criteria. For example, we chose to exclude subjects with C4 or higher injuries because our treatment protocol calls for injection of cells above and below the injury site. A person with a C4 injury would require injection of cells into C3, the part of the spinal cord where the phrenic nucleus (that controls breathing) is located. I believe that we would need to do a separate phase 2 clinical trial just for high quads where the cells would be injected into the injury site and below. Such a clinical trial could also focus on motor and sensory recovery in the shoulders and arms. Because of the increased risk of cell injection into the upper cervical spinal cord, I think that it would be better to have more evidence in human trials showing that the treatment is safe and beneficial before doing it in somebody with high cervical injury.

    The cause of injury is also important. One of the most important differences between spinal cord injury is whether the lumbosacral gray matter was damaged (the part of the spinal cord where the neurons controlling the legs in the lower spinal cord). The spinal cord ends at vertebral level L1. Below L1, the spinal canal contains only spinal roots. The lumbosacral enlargement is located between T11 and L1 vertebral levels. Injury to this part of the spinal cord may lead to flaccid paralysis with consequent atrophy of muscles in the legs. Lumbosacral injuries may have a different response to treatment than injuries that primarily affect white matter in the lower cervical and upper thoracic spinal cord. The treatment with umbilical cord blood mononuclear cells and lithium is designed primarily for (the mononuclear cells) bridging the injury site and (the lithium) stimulating neurotrophin production. The therapy should stimulate axonal growth.

    For people with lumbosacral injuries, we need a different kind of cell therapy, i.e. neural stem cells that can replace neurons. We are working hard on establishing a cell source for neural stem cells. At the present, there are only three sources of neural stem cells. First, embryonic stem cells can be differentiated into neural stem cells. Second, fetal neural stem cells can be obtained from aborted fetuses. Third, adult neural stem cells can be obtained from a person's brain. The first two sources are not immune-compatible. While the last is immune-compatible (if obtained from the brain of the person), it is difficult to jsutify removing part of the brain to treat the spinal cord. By the way, while a number of groups have reported success in making neural stem cells from bone marrow or mesenchymal stem cells, these have not been particularly reproducible nor have the studies provided credible evidence of beneficial effects of such cells in animal spinal cord injury models.

    Fortunately, a new option has recently been made available for creating immune-compatible neural stem cells without having to take out a chunk of one's brain. These are induced pluripotent stem (IPS) cells. By insertion of four genes into skin cells (fibroblasts), several groups have shown that it is possible to create embryonic stem cell like pluripotent cells. Unfortunately, much work still needs to be done to ensure the safety of such cells because they have a propensity to grow into tumors when transplanted. We and many other groups are working hard testing IPS cells in animal models and figuring out how to make IPS cells safer. I believe that IPS cells will become available for clinical trials in about 3 years.

    Finally, what about other kinds of spinal cord injuries, such as those resulting from ischemia (loss of blood flow) or transverse myelitis (probably inflammation mediated)? I believe that these should not be tested together with traumatic spinal cord injury because both the causes and response of these injuries to umbilical cord blood mononuclear cells and lithium may be different. The best way is to carry out a separate phase 2 trial on people with ischemic and transverse myelitis. Such a trial would be open label and intended to establish safety and feasibility of the cell transplant and lithium therapy for transverse myelitis. Such a clinical trial could be done with about 20 people.

    Wise.
    Last edited by Wise Young; 06-30-2009 at 02:22 PM.

  8. #168
    Quote Originally Posted by Wise Young View Post
    skeaman,

    I don't feel comfortable showing videos of walking rats or patients, even though I have both. The reason is because rats and people may be walking for reasons other than the treatment. It is always easy to select one example and it is human to think that everybody will respond like the example. Please understand that I am not against companies showing ads with beautiful smiling people using their products. That is marketing. I don't believe that it is a good idea to market experimental therapies that are on clinical trial. I also think that it is not a good idea to give numbers like 70% recovery of rats because the relationship of animal recovery to human recovery is tenuous and depends on both injury type and severity.

    On the other hand, I think that it is important that people know that animal studies have shown that the proposed therapy is beneficial in animals, that they are aware of the information concerning safety of the therapy, and they understand rationale for testing the therapy. There is no guarantee of treatment effect or safety. Participating in a clinical trial is a service that people are performing for the community. People are taking a risk on behalf of other people with spinal cord injury. An experimental therapy means that there is not yet convincing data indicating efficacy. They are taking the risk in order to help accelerate the development of therapies for spinal cord injury. That is why the clinical trial does not charge for the therapy. If the therapy works, that is great. If it doesn't work, we need to go on to something else and not waste valuable resources on something that is not safe or effective.

    In the case of umbilical cord blood and lithium, there is data from animal studies indicating that mononuclear cells alone and lithium alone are beneficial in spinal cord injury. We hypothesize that the combination of the two treatment would be better than each one alone. That is why the trial will test each of the therapy alone and the two therapies together. In order to ensure the highest likelihood of showing a significant treatment effect, we chose certain inclusion and exclusion criteria that would ensure that the patients have similar injuries. The greater the variability of people in each treatment group, the more subjects we will need to show a significant difference.

    The injury type and level also determines which outcome measures can be used. For example, if the study includes people with cervical and thoracic spinal cord injury, we must use an outcome measure that can be applied to both. Obviously, we cannot compare arm function in people with cervical and thoracic spinal cord injuries because the latter will not be affected by the injury. On the other hand, changes in motor and sensory scores are valid for both cervical and thoracic spinal cord injury. Likewise, comparison of walking scores may also be valid because both cervical and thoracic spinal cord injury cause impairment of walking.

    Safety considerations play a role in the inclusion and exclusion criteria. For example, we chose to exclude subjects with C4 or higher injuries because our treatment protocol calls for injection of cells above and below the injury site. A person with a C4 injury would require injection of cells into C3, the part of the spinal cord where the phrenic nucleus (that controls breathing) is located. I believe that we would need to do a separate phase 2 clinical trial just for high quads where the cells would be injected into the injury site and below. Such a clinical trial could also focus on motor and sensory recovery in the shoulders and arms. Because of the increased risk of cell injection into the upper cervical spinal cord, I think that it would be better to have more evidence in human trials showing that the treatment is safe and beneficial before doing it in somebody with high cervical injury.

    The cause of injury is also important. One of the most important differences between spinal cord injury is whether the lumbosacral gray matter was damaged (the part of the spinal cord where the neurons controlling the legs in the lower spinal cord). The spinal cord ends at vertebral level L1. Below L1, the spinal canal contains only spinal roots. The lumbosacral enlargement is located between T11 and L1 vertebral levels. Injury to this part of the spinal cord may lead to flaccid paralysis with consequent atrophy of muscles in the legs. Lumbosacral injuries may have a different response to treatment than injuries that primarily affect white matter in the lower cervical and upper thoracic spinal cord. The treatment with umbilical cord blood mononuclear cells and lithium is designed primarily for (the mononuclear cells) bridging the injury site and (the lithium) stimulating neurotrophin production. The therapy should stimulate axonal growth.

    For people with lumbosacral injuries, we need a different kind of cell therapy, i.e. neural stem cells that can replace neurons. We are working hard on establishing a cell source for neural stem cells. At the present, there are only three sources of neural stem cells. First, embryonic stem cells can be differentiated into neural stem cells. Second, fetal neural stem cells can be obtained from aborted fetuses. Third, adult neural stem cells can be obtained from a person's brain. The first two sources are not immune-compatible. While the last is immune-compatible (if obtained from the brain of the person), it is difficult to jsutify removing part of the brain to treat the spinal cord. By the way, while a number of groups have reported success in making neural stem cells from bone marrow or mesenchymal stem cells, these have not been particularly reproducible nor have the studies provided credible evidence of beneficial effects of such cells in animal spinal cord injury models.

    Fortunately, a new option has recently been made available for creating immune-compatible neural stem cells without having to take out a chunk of one's brain. These are induced pluripotent stem (IPS) cells. By insertion of four genes into skin cells (fibroblasts), several groups have shown that it is possible to create embryonic stem cell like pluripotent cells. Unfortunately, much work still needs to be done to ensure the safety of such cells because they have a propensity to grow into tumors when transplanted. We and many other groups are working hard testing IPS cells in animal models and figuring out how to make IPS cells safer. I believe that IPS cells will become available for clinical trials in about 3 years.

    Finally, what about other kinds of spinal cord injuries, such as those resulting from ischemia (loss of blood flow) or transverse myelitis (probably inflammation mediated)? I believe that these should not be tested together with traumatic spinal cord injury because both the causes and response of these injuries to umbilical cord blood mononuclear cells and lithium may be different. The best way is to carry out a separate phase 2 trial on people with ischemic and transverse myelitis. Such a trial would be open label and intended to establish safety and feasibility of the cell transplant and lithium therapy for transverse myelitis. Such a clinical trial could be done with about 20 people.

    Wise.
    Thanks for replaying boy that is a long letter . I see where you are coming from I think I got the just of it we will just have to wait for 6 or 8 years can you say is that mis leading any body but if you can get fit and able people giving money they like to see what it is going to as I say we must branch out to other people ps i would love to be one of the 20 people as i am sure others would be

  9. #169
    Quote Originally Posted by Wise Young View Post
    skeaman,

    I don't feel comfortable showing videos of walking rats or patients, even though I have both. The reason is because rats and people may be walking for reasons other than the treatment. It is always easy to select one example and it is human to think that everybody will respond like the example. Please understand that I am not against companies showing ads with beautiful smiling people using their products. That is marketing. I don't believe that it is a good idea to market experimental therapies that are on clinical trial. I also think that it is not a good idea to give numbers like 70% recovery of rats because the relationship of animal recovery to human recovery is tenuous and depends on both injury type and severity.

    On the other hand, I think that it is important that people know that animal studies have shown that the proposed therapy is beneficial in animals, that they are aware of the information concerning safety of the therapy, and they understand rationale for testing the therapy. There is no guarantee of treatment effect or safety. Participating in a clinical trial is a service that people are performing for the community. People are taking a risk on behalf of other people with spinal cord injury. An experimental therapy means that there is not yet convincing data indicating efficacy. They are taking the risk in order to help accelerate the development of therapies for spinal cord injury. That is why the clinical trial does not charge for the therapy. If the therapy works, that is great. If it doesn't work, we need to go on to something else and not waste valuable resources on something that is not safe or effective.

    In the case of umbilical cord blood and lithium, there is data from animal studies indicating that mononuclear cells alone and lithium alone are beneficial in spinal cord injury. We hypothesize that the combination of the two treatment would be better than each one alone. That is why the trial will test each of the therapy alone and the two therapies together. In order to ensure the highest likelihood of showing a significant treatment effect, we chose certain inclusion and exclusion criteria that would ensure that the patients have similar injuries. The greater the variability of people in each treatment group, the more subjects we will need to show a significant difference.

    The injury type and level also determines which outcome measures can be used. For example, if the study includes people with cervical and thoracic spinal cord injury, we must use an outcome measure that can be applied to both. Obviously, we cannot compare arm function in people with cervical and thoracic spinal cord injuries because the latter will not be affected by the injury. On the other hand, changes in motor and sensory scores are valid for both cervical and thoracic spinal cord injury. Likewise, comparison of walking scores may also be valid because both cervical and thoracic spinal cord injury cause impairment of walking.

    Safety considerations play a role in the inclusion and exclusion criteria. For example, we chose to exclude subjects with C4 or higher injuries because our treatment protocol calls for injection of cells above and below the injury site. A person with a C4 injury would require injection of cells into C3, the part of the spinal cord where the phrenic nucleus (that controls breathing) is located. I believe that we would need to do a separate phase 2 clinical trial just for high quads where the cells would be injected into the injury site and below. Such a clinical trial could also focus on motor and sensory recovery in the shoulders and arms. Because of the increased risk of cell injection into the upper cervical spinal cord, I think that it would be better to have more evidence in human trials showing that the treatment is safe and beneficial before doing it in somebody with high cervical injury.

    The cause of injury is also important. One of the most important differences between spinal cord injury is whether the lumbosacral gray matter was damaged (the part of the spinal cord where the neurons controlling the legs in the lower spinal cord). The spinal cord ends at vertebral level L1. Below L1, the spinal canal contains only spinal roots. The lumbosacral enlargement is located between T11 and L1 vertebral levels. Injury to this part of the spinal cord may lead to flaccid paralysis with consequent atrophy of muscles in the legs. Lumbosacral injuries may have a different response to treatment than injuries that primarily affect white matter in the lower cervical and upper thoracic spinal cord. The treatment with umbilical cord blood mononuclear cells and lithium is designed primarily for (the mononuclear cells) bridging the injury site and (the lithium) stimulating neurotrophin production. The therapy should stimulate axonal growth.

    For people with lumbosacral injuries, we need a different kind of cell therapy, i.e. neural stem cells that can replace neurons. We are working hard on establishing a cell source for neural stem cells. At the present, there are only three sources of neural stem cells. First, embryonic stem cells can be differentiated into neural stem cells. Second, fetal neural stem cells can be obtained from aborted fetuses. Third, adult neural stem cells can be obtained from a person's brain. The first two sources are not immune-compatible. While the last is immune-compatible (if obtained from the brain of the person), it is difficult to jsutify removing part of the brain to treat the spinal cord. By the way, while a number of groups have reported success in making neural stem cells from bone marrow or mesenchymal stem cells, these have not been particularly reproducible nor have the studies provided credible evidence of beneficial effects of such cells in animal spinal cord injury models.

    Fortunately, a new option has recently been made available for creating immune-compatible neural stem cells without having to take out a chunk of one's brain. These are induced pluripotent stem (IPS) cells. By insertion of four genes into skin cells (fibroblasts), several groups have shown that it is possible to create embryonic stem cell like pluripotent cells. Unfortunately, much work still needs to be done to ensure the safety of such cells because they have a propensity to grow into tumors when transplanted. We and many other groups are working hard testing IPS cells in animal models and figuring out how to make IPS cells safer. I believe that IPS cells will become available for clinical trials in about 3 years.

    Finally, what about other kinds of spinal cord injuries, such as those resulting from ischemia (loss of blood flow) or transverse myelitis (probably inflammation mediated)? I believe that these should not be tested together with traumatic spinal cord injury because both the causes and response of these injuries to umbilical cord blood mononuclear cells and lithium may be different. The best way is to carry out a separate phase 2 trial on people with ischemic and transverse myelitis. Such a trial would be open label and intended to establish safety and feasibility of the cell transplant and lithium therapy for transverse myelitis. Such a clinical trial could be done with about 20 people.

    Wise.
    dear dr. young,
    it would bring a lot of hope to most of us to see the videos of people walking, about which you are talking about.
    please reconsider.
    thanks
    gautam

  10. #170
    Dr Young
    I am a C4/5 quad and would pay almost anything just to improve to a C5/6 level. The difference in functionality, independence, posture and comfort in the wheelchair is profound between these levels. It would relieve so much pressure on my wife.
    Is there any chance that this procedure could produce, not cure, but improvement?

    PLS

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