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Thread: For those who understand spanish (Dr. Vaquero)

  1. #201
    Senior Member KIM's Avatar
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    Quote Originally Posted by JamesMcM View Post
    No I understand it doesn't depend on you! I just mean that really you've been our only source of information on this clinical trial, you have been talking about it for quite some time I think we all doubted what you were saying, seems we were mistaken! There have been no quadriplegics treated? Does the doctor plan on doing any cervical injuries? Any idea why he chose only paraplegics. And how much money is needed?
    Well so far you guys are finding the info I posted some but not all you are discusing, these are the results 1/2 phase and Im c6 complete I will tell how Im doing whenever it happens . More phases are to come this are the first steps safety and so on with these results . Lets see what the next phases provide. Quad are beeing done in this phase we are now. About money it is needed but hell this trial is a lot cheaper than others mentioned in this forum. Maybe a million dollars could complete the whole trial.

  2. #202
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    I truly appreciate Nowhere Man's review of the paper. One thing puzzles me though. You seem to have a very high regard for Dr. Young. Isn't his the study where there was great improvement in walking scores attributed to stem cells but also coincident with extensive walking training. So much so that there is no way to separate the effects of cells vs. training? That methodology seems highly suspect to me. Perhaps I misunderstand.

    As for this paper, I'm encouraged by the fact that they focused on chronic complete. Way too many studies use acute test subjects where there is no way to determine if the investigators modifications are the cause for changes observed.

  3. #203
    Quote Originally Posted by Mize View Post
    I truly appreciate Nowhere Man's review of the paper. One thing puzzles me though. You seem to have a very high regard for Dr. Young. Isn't his the study where there was great improvement in walking scores attributed to stem cells but also coincident with extensive walking training. So much so that there is no way to separate the effects of cells vs. training? That methodology seems highly suspect to me. Perhaps I misunderstand.
    In our upcoming US Phase IIb Trial there will be 3 groups of 9. Umbilical cord blood injections + lithium + intensive walking, umbilical cord blood injections + intensive walking, only intensive walking. All subjects ASIA A, chronic, C5 - T10.

  4. #204
    Quote Originally Posted by Nowhere Man View Post
    Thank you for posting this. Its way better than the paper itself. People should skip the paper and just read the supplementary data.

    This is my opinion on the paper. I make many assumptions.

    a) I do not trust Dr. Vaquero. That is my personal opinion. This is based on his animal studies that to me were too good to be true. So, I take this study with a huge grain of salt. At least, this study does not claim anything too outrageous nor does it claim long distance regeneration (although he says its possible). So that is a plus. Here is Dr. Young's opinion on one of Dr. Vaquero's animal studies: http://sci.rutgers.edu/forum/showthr...hlight=Vaquero
    (Post #21). Dr. Vaquero claimed that treated rats had a bbb (walking) score of 17 out of 21 possible. 21 = normal rat. The control groups had bbb score of 0. No lab had ever had such results and no lab has anything even close to that since. It's been 10 years! Dr. Young says "If these results are as robust as they claim, there should be many laboratories showing these results. Let's see if this is true." Well, it's been 10 years!

    b) Things like bowel, bladder, and sexual recovery is based on a questionnaire to the patients. Right there, I throw it out. SCI patients, especially SCI, make shit up in their heads as recovery. SCI lie to themselves about any phantom sensation because they badly want to recover. I've seen people here claim recovery for scam stem cell centers & foot rub doctors. If you want me to believe in recovery of sensation or control in b,b,s, then it must be witnessed firsthand by clinicians and regulatory agencies or video. It's simple to do.
    But, nonetheless, there was no claimed FULL recovery of bladder, bowel, or sexual function. Except in 1 patient, in which they claim he had recovered ability to urinate and feel bladder normally.

    "From a clinical point of view, the improvement in bladder sphincter control results in the appearance of a feeling of "full bladder" and at a later stage by the identification of strange sensations, sometimes described as "flushing or heat" followed a few minutes later, of involuntary bladder emptying. The presence of these feelings, sometimes late in the follow-up (after 9 months, in patients 11 and 17) allows patients to are without collector when they are at home, as it gives them time to go to empty your bladder. One patient (patient 04) without any sensation of bladder filling prior to treatment, emptied his bladder by catheterization, he started feeling urination three month after surgery and evolved to a total control, emptying the bladder completely and entirely voluntary, at the end of the follow-up.(pg. 53).

    But there were many who reported partial sensation or partial control of bladder. As for bowel function:
    "It was a surprising and almost constant the information from patients about that after surgery, bowel movement was improved, so that they noticed peristalsis, and defecation was clearly modified in terms of frequency and time they needed, going even to defecate daily and within minutes, without need of laxatives. As the improvement observed with the IANR-SCIFRS scale, improvement is immediate and very strong in the first 3 months after surgery, it is progressive in time and is described as extremely rewarding in almost all periodic reports from our patients and their videotaped statements.(pg.62 supp.)."

    Nothing in that about being able to voluntarily defecate or feel the need to go. Its very ambiguous when they talk about peristalsis & reduced bowel program times. That could very well mean nothing. But the mean score on their scale used was 1.25 after 12 months. 1.0 = "Partial control without sensation or no control with partial sensation"(p.41-42 supp). So there were reports by the patients of having partial control or sensation.

    Sexual function:
    "In the IANR-SCIFRS scale, a final section related to sexual function, that rate independently, is contemplated. It applies only to men, and has also been subject of evaluation and statistical analysis throughout the study. Our analysis showed a progressive improvement, reaching statistical significant difference compared to baseline at 3 months after surgery. This improvements generally consisted of an increase in number and duration of erections, increased sensitivity, and even recovery of ejaculations, previously lost. One patient (patient 14, with SCI at D7-D8 level) reported involuntary loss of sperm that he had not had since the time of the SCI, more than 25 years ago."
    --So I'm guessing, the "One patient" who reported "involuntary loss of sperm", is the best recovery they had? I don't see any mention of voluntary ejaculation or Orgasm. So imo, sexual function was not restored.

    Again, the bbs was via a questionnaire. Meaningless to me, because I know SCI and how they make shlt up. The only objective evidence was urodynamics.
    "The ratio of maximum cystometric capacity and detrusor pressure determines bladder compliance, and, therefore, an increase in bladder compliance objectively reflects the improvements in bladder function after treatment. (p. 10)."

    I disagree that urodynamics of capacity & detrusor pressure objectively reflects sensation &/or control. I don't know why they couldn't test the patients for sensation/control while they already had them in the room while they had them in a chair, with sensors in their bladder & potentially up the rear (as many urodynamic tests do)!

    c) I'm pretty sure the patient with best motor return was the woman in the swimming pool. Not functional at all. Not much motor return via ASIA tests (mean score went from roughly 50 to 53). But scores ignore ab muscles which is where these patients were injured. Seems like there was a lot of recovery of pin-prick and light touch sensations (mean went from roughly 57 to 80) as you guys can see on the pictures of bodies with yellow & red. At least Asia tests are objective. So that does sound good that patients are gaining skin sensations. But they could be very dull sensations and not pre-injury like, I'm not sure.

    d) Overall, I don't trust Dr. Vaquero. But in this paper, he doesn't make any wild claims. Since most recoveries start by 3 months, as early as a week, this looks to me like a re-awakening intact circuitry as opposed to long distance regeneration. Especially because reported recovered sensation/motor was at the appropriate locations. Regeneration would not restore sensory axons to exact target in brain. Plus animal studies showed no long distance regeneration. But, that is ok. I think everyone needs to restore whatever remaining axons they have. If these results are true, I bet it would be even better in incomplete SCI. I'd love to hear Dr.Young's opinion, and that of other SCI scientists.
    Yeah, what makes me so hesitant to scream hurray is how many bone marrow stem cellclinical trials ( I don't even know how many times they've been attempted in animals ) there have been that have shows little to no improvements. Around the One year mark after I was injured I was searching the clinical trial.gov website there were quite a few of them, ( this could've been one of them) some already completed;nothing came of them though. In fact I've expressed on here more than once my confusion why researchers continue to try using bone marrow stem cells to treat spinal cord, because of how often I seen that were being used, but but nothing coming from it. Then all of a sudden this, comes out. And I'm left wondering what makes these cells differentFrom all the other clinical trials using cells taken from bone marrow. I understand that stem cells can be reprogrammed so to speak, and that's what they claim to do in the Russian trial: they harvest cells from the bone marrow and "reprogram" them to neural stem cells;which have been stated to have the most potential. Is this the case here, where the stem cells designed or reprogrammed to have more potential, I haven't seen any mention of that. the injection process could be what makes the difference, but I don't know what the standard procedure to administering stem cells to cord is. In the link that nowhere man provided, Dr. Young did mention that they seem to be using far too many cells in their animal models.

    You're absolutely correct, people do delude themselves in search of recoveryafter SCI among other things. I imagine that becomes much more "prominent" after a potential treatment. And I watched the video with the lady in the pool, the walking or more so standing was interesting , But everything else all of the floating leg movements if you put me in the pool my legs would do the same thing with involuntary spasms. They can respond in a functional movement,caused by touch or movements from the rest of my body. Not saying that that was the case, just something worth noting.

    One last thing, all of these injuries that had improved bladder capacity;there's just one thing im wondering. Something I'm very concerned about for myself (all of us should be), bladder shrinkage! It's obviously more prominent with indwelling catheter's, basically the bladder can shrink and harden permanently. I've been told by my urologist that can become irreversible, I'm just wondering how could the bladder capacity increase; if that were to have taken place, with so many patients so long post injury it's likely that it has happened. maybe that's why some of the patient bladder capacity didn't change or improve as much! At the same time I was wondering if the "reactivating" of bladder function would reverse bladder shrinkage (if that's even the case)
    Last edited by JamesMcM; 06-18-2016 at 02:23 AM.

  5. #205
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by JamesMcM View Post
    Yeah, what makes me so hesitant to scream hurray is how many bone marrow stem cellclinical trials ( I don't even know how many times they've been attempted in animals ) there have been that have shows little to no improvements. Around the One year mark after I was injured I was searching the clinical trial.gov website there were quite a few of them, ( this could've been one of them) some already completed;nothing came of them though. In fact I've expressed on here more than once my confusion why researchers continue to try using bone marrow stem cells to treat spinal cord, because of how often I seen that were being used, but but nothing coming from it. Then all of a sudden this, comes out. And I'm left wondering what makes these cells differentFrom all the other clinical trials using cells taken from bone marrow. I understand that stem cells can be reprogrammed so to speak, and that's what they claim to do in the Russian trial: they harvest cells from the bone marrow and "reprogram" them to neural stem cells;which have been stated to have the most potential. Is this the case here, where the stem cells designed or reprogrammed to have more potential, I haven't seen any mention of that. the injection process could be what makes the difference, but I don't know what the standard procedure to administering stem cells to cord is. In the link that nowhere man provided, Dr. Young did mention that they seem to be using far too many cells in their animal models.

    You're absolutely correct, people do delude themselves in search of recoveryafter SCI among other things. I imagine that becomes much more "prominent" after a potential treatment. And I watched the video with the lady in the pool, the walking or more so standing was interesting , But everything else all of the floating leg movements if you put me in the pool my legs would do the same thing with involuntary spasms. They can respond in a functional movement,caused by touch or movements from the rest of my body. Not saying that that was the case, just something worth noting.

    One last thing, all of these injuries that had improved bladder capacity;there's just one thing im wondering. Something I'm very concerned about for myself (all of us should be), bladder shrinkage! It's obviously more prominent with indwelling catheter's, basically the bladder can shrink and harden permanently. I've been told by my urologist that can become irreversible, I'm just wondering how could the bladder capacity increase; if that were to have taken place, with so many people post injury it's likely that it has happened. maybe that's why some of the patient bladder capacity didn't change or improve as much! At the same time I was wondering if the "reactivating" of bladder function would reverse bladder shrinkage (if that's even the case)
    Proper questions
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  6. #206
    Basically it's stated the stem cells are mixEd in vitro with "Various chemicals" that's all I can really find. Who knows what those chemicals are, neurotrophins maybe,I have no idea how that would be beneficial!

  7. #207
    Quote Originally Posted by JamesMcM View Post
    In the link that nowhere man provided, Dr. Young did mention that they seem to be using far too many cells in their animal models.
    Not that I know anything about science, but if you are testing for safety wouldn't it make sense to overload an animal to see if you could provoke a bad reaction?

    If no reaction with too many cells, then does it show better safety than if you had used a lower amount?

  8. #208
    This is very good news and holds a lot of promise.

    It is intersting that there is a disussion about the dosage of stemcells. In the Stemcells Inc. Phase 2 cervical trial the dosage was 15/30/40 million HuCNS‐SC? cells.

    In the Vaquero-trial the dosage is 130 to 260 million cells as I can understand it. Maybe there is something there.

    It would also be interesting to know if its possible to continue the injections for several years.

    I think that the images of swimming pool are great - its a huge leap forward. It has implications for muscles, bones, pressure wounds and overall health + a probably a lot more.




    "Given that

    our cell therapy medicament had a concentration of
    105 cells/μ L, the amount of administered cells per microinjection
    ranged from 5 ?~ 106 MSCs to 150 ?~ 106
    MSCs (average, approximately 36 ?~ 106 MSCs). In
    each patient, in addition to injections into the injured
    spinal cord tissue, 30 ?~ 106 MSCs (300 μ L) were administered
    in the perilesional subarachnoid space by
    means of an intrathecal catheter (mod BOC 8711,
    Medtronic Inc.). Intramedullary injections of MSCs
    were performed through a laminectomy and durotomy,
    and we used a microinjection pump (mod 310,
    Stoelting Co.) connected to a 100-μ L Hamilton syringe
    with a 20-gauge needle, at a microinjection rate of
    10 μ L/min, which was modified depending on the morphological
    characteristics of the lesion and the tissue
    consistency. After cell administration, the dura mater
    was hermetically closed, to prevent leakage. Three
    months after surgery, all patients received another
    30 ?~ 106 MSCs into the subarachnoid space by lumbar
    tapping through a 20-gauge needle.The total number
    of MSCs administered to each patient ranged from
    130 ?~ 106 to 260 ?~ 106 (mean, 202.5 ?~ 106 ; SD,
    46.73 ?~ 106 ). Surgical planning in the patients of the
    series is provided in the Supplementary Appendix (See
    Supplementary Figures S3 to S14 )."

  9. #209
    Quote Originally Posted by niallel View Post
    Not that I know anything about science, but if you are testing for safety wouldn't it make sense to overload an animal to see if you could provoke a bad reaction?

    If no reaction with too many cells, then does it show better safety than if you had used a lower amount?
    Yeah you would think, but from what Dr. Young wrote it sounded like that amount of stem cells would basically overflow the lesion

    " cells: 50 µliters. This is 50 cubic millimeters. They used 25 µliter Hamilton syringes, suggesting that they had to change syringes mid-injection. The rat spinal cord itself is only 3 mm in diameter and the impact site has a volume of probably 10-20 µliters. So, they are injecting over a suspension of cells that is over twice the volume of the spinal cord itself. The cells must be going every where."

  10. #210
    Quote Originally Posted by Nowhere Man View Post
    Thank you for posting this. Its way better than the paper itself. People should skip the paper and just read the supplementary data.

    This is my opinion on the paper. I make many assumptions.

    a) I do not trust Dr. Vaquero. That is my personal opinion. This is based on his animal studies that to me were too good to be true. So, I take this study with a huge grain of salt. At least, this study does not claim anything too outrageous nor does it claim long distance regeneration (although he says its possible). So that is a plus. Here is Dr. Young's opinion on one of Dr. Vaquero's animal studies: http://sci.rutgers.edu/forum/showthr...hlight=Vaquero
    (Post #21). Dr. Vaquero claimed that treated rats had a bbb (walking) score of 17 out of 21 possible. 21 = normal rat. The control groups had bbb score of 0. No lab had ever had such results and no lab has anything even close to that since. It's been 10 years! Dr. Young says "If these results are as robust as they claim, there should be many laboratories showing these results. Let's see if this is true." Well, it's been 10 years!

    b) Things like bowel, bladder, and sexual recovery is based on a questionnaire to the patients. Right there, I throw it out. SCI patients, especially SCI, make shit up in their heads as recovery. SCI lie to themselves about any phantom sensation because they badly want to recover. I've seen people here claim recovery for scam stem cell centers & foot rub doctors. If you want me to believe in recovery of sensation or control in b,b,s, then it must be witnessed firsthand by clinicians and regulatory agencies or video. It's simple to do.
    But, nonetheless, there was no claimed FULL recovery of bladder, bowel, or sexual function. Except in 1 patient, in which they claim he had recovered ability to urinate and feel bladder normally.

    "From a clinical point of view, the improvement in bladder sphincter control results in the appearance of a feeling of "full bladder" and at a later stage by the identification of strange sensations, sometimes described as "flushing or heat" followed a few minutes later, of involuntary bladder emptying. The presence of these feelings, sometimes late in the follow-up (after 9 months, in patients 11 and 17) allows patients to are without collector when they are at home, as it gives them time to go to empty your bladder. One patient (patient 04) without any sensation of bladder filling prior to treatment, emptied his bladder by catheterization, he started feeling urination three month after surgery and evolved to a total control, emptying the bladder completely and entirely voluntary, at the end of the follow-up.(pg. 53).

    But there were many who reported partial sensation or partial control of bladder. As for bowel function:
    "It was a surprising and almost constant the information from patients about that after surgery, bowel movement was improved, so that they noticed peristalsis, and defecation was clearly modified in terms of frequency and time they needed, going even to defecate daily and within minutes, without need of laxatives. As the improvement observed with the IANR-SCIFRS scale, improvement is immediate and very strong in the first 3 months after surgery, it is progressive in time and is described as extremely rewarding in almost all periodic reports from our patients and their videotaped statements.(pg.62 supp.)."

    Nothing in that about being able to voluntarily defecate or feel the need to go. Its very ambiguous when they talk about peristalsis & reduced bowel program times. That could very well mean nothing. But the mean score on their scale used was 1.25 after 12 months. 1.0 = "Partial control without sensation or no control with partial sensation"(p.41-42 supp). So there were reports by the patients of having partial control or sensation.

    Sexual function:
    "In the IANR-SCIFRS scale, a final section related to sexual function, that rate independently, is contemplated. It applies only to men, and has also been subject of evaluation and statistical analysis throughout the study. Our analysis showed a progressive improvement, reaching statistical significant difference compared to baseline at 3 months after surgery. This improvements generally consisted of an increase in number and duration of erections, increased sensitivity, and even recovery of ejaculations, previously lost. One patient (patient 14, with SCI at D7-D8 level) reported involuntary loss of sperm that he had not had since the time of the SCI, more than 25 years ago."
    --So I'm guessing, the "One patient" who reported "involuntary loss of sperm", is the best recovery they had? I don't see any mention of voluntary ejaculation or Orgasm. So imo, sexual function was not restored.

    Again, the bbs was via a questionnaire. Meaningless to me, because I know SCI and how they make shlt up. The only objective evidence was urodynamics.
    "The ratio of maximum cystometric capacity and detrusor pressure determines bladder compliance, and, therefore, an increase in bladder compliance objectively reflects the improvements in bladder function after treatment. (p. 10)."

    I disagree that urodynamics of capacity & detrusor pressure objectively reflects sensation &/or control. I don't know why they couldn't test the patients for sensation/control while they already had them in the room while they had them in a chair, with sensors in their bladder & potentially up the rear (as many urodynamic tests do)!

    c) I'm pretty sure the patient with best motor return was the woman in the swimming pool. Not functional at all. Not much motor return via ASIA tests (mean score went from roughly 50 to 53). But scores ignore ab muscles which is where these patients were injured. Seems like there was a lot of recovery of pin-prick and light touch sensations (mean went from roughly 57 to 80) as you guys can see on the pictures of bodies with yellow & red. At least Asia tests are objective. So that does sound good that patients are gaining skin sensations. But they could be very dull sensations and not pre-injury like, I'm not sure.

    d) Overall, I don't trust Dr. Vaquero. But in this paper, he doesn't make any wild claims. Since most recoveries start by 3 months, as early as a week, this looks to me like a re-awakening intact circuitry as opposed to long distance regeneration. Especially because reported recovered sensation/motor was at the appropriate locations. Regeneration would not restore sensory axons to exact target in brain. Plus animal studies showed no long distance regeneration. But, that is ok. I think everyone needs to restore whatever remaining axons they have. If these results are true, I bet it would be even better in incomplete SCI. I'd love to hear Dr.Young's opinion, and that of other SCI scientists.
    Since no one has come up with solid arguments to support the idea things are better than you say in your review, I guess your review is correct.
    In God we trust; all others bring data. - Edwards Deming

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