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Thread: ChinaSCINet Trials

  1. #1

    ChinaSCINet Trials

    Quote Originally Posted by Boomer
    Hello Dr. Wise Young. My name is Paul.I am a T-12 complete para. You are probably getting sick of getting asked about the 2008 stem cell trials in China so I will keep this short. It's just I can't get any questions answered up here in Saskatchewan , Canada. Anyways I would like to know where I can get updated on maybe becoming a clincal trial patient and if not when will this procedure be available to the public. Thanks for your time and your work. Paul.............
    Paul, let me try to answer your question here. Although I have tried answering this question many times, most people may have not see what I wrote or I have not answered their questions. In the past, I have tried to summarize the trials first and then answered the questions at the end. This time, let me answer a set of questions as best as I can. Please note that not all the decisions have been made and therefore I don't have answer for all the questions.

    Can I be a subject in this clinical trial?
    • The answer is yes but neither the details nor the timing the trials have been determined. My most optimistic estimate is that the phase 3 trial will not begin until mid-2008. The reason is that we must complete two other phase 2 trials before we get to the phase 3 trial testing the combination of umbilical cord blood mononuclear cell transplants and lithium.
    • We also have several difficult hurdles in front of us. This includes getting China's Ministry of Health and sFDA approval for the first combination cell transplant plus drug combination therapy. It will be the the first multicenter cell transplantation clinical trial study.
    • While people from outside China can participate in the study, the study is obvious in China and participants are required to participate in the clinical trial in China, including all followup visits.


    What are the planned clinical trials?
    • Phase 1 Oral lithium. We are currently doing a phase 1 open-label oral lithium trial in 20 subjects. The goal is to assess the safety and feasilibility of giving a 6-week course of lithium to people with chronic spinal cord injury. The lithium does will be gradually increased from 250 mg twice a day until a serum level of 0.6-10 mM is reached and then maintained to the 6th week. This study is being done only at Hong Kong University.
    • Phase 1/2 Cord blood mononuclear cell (CBMC) transplants. We will transplant HLA-matched CBMC into 60 patients with chronic spinal cord injury. At the present, it looks as if we will transplant about 8 million cells through 4 injections sites above and below the injury site though small laminectomies. Half of the subjects will be randomized to receive a single bolus of methylprednisolone (30 mg/kg) at the time of transplantation. The goal is to ascertain whether the cells can be safely transplanted into spinal cords of people with chronic spinal cord injury and whether methylprednisolone can be safely used to improve survival of the cells. Magnetic resonance imaging and neurological outcome will be assessed at 6 weeks and 6 months after transplantation. Subjects will be expected to stay in the hospital for 6 weeks. The study will likely be carried out at 6 hospitals in China.
    • Phase 2 Oral lithium. We will randomize 60 subjects with chronic spinal cord injury to a 6-week course of lithium or placebo, assess neurological outcome at 6 weeks and 6 months. The goal is to ascertain whether lithium alone has any effects on neurological recovery in people with chronic spinal cord injury. This study will be carried out in China.
    • Phase 3 CBMC transplant ± lithium. We will transplanted HLA matched CBMC into the spinal cord of 400 people with chronic spinal cord injury. After transplantation, they will be randomized to lithium or no lithium for 6 weeks. The subjects will then be followed at 6 week, 6 months, and 12 months. The protocol will be similar to the phase 1/2 CBMC transplant trial. Subjects will be expected to stay in the hospital for 6 weeks.


    What is the rationale for the study?
    • Several laboratories have shown that umbilical cord blood cells transplanted ot the spinal cord improve recovery of rats with spinal cord injury. These studies have been difficult to replicate. In preliminary studies, we have shown that both rat neonatal blood and human umbilical cord blood mononuclear cells will survive when transplanted into spinal cord of immunosuppressed rats and tha lithium strongly stimulates these cells to secrete neurotrophins (or growth factors that stimulate axonal growth).
    • Our goal is to test a combination therapy consisting of three components: a cellular bridge across the injury site, a continuing source of growth factors, and blockers of axonal growth inhibitors. The planned clinical trials will test the individually and then together two components of the combination, i.e. the cell bridge and the source of growth factors. We are hoping to add growth inhibitor blockers as the third part of the combination.


    What are the expected results of the trials?
    • We of course hope that the trials will show that the cord blood mononuclear cells and lithium will be beneficial for neurological recovery.
    • Three outcomes are possible.
      1. Neither transplant or transplant+lithium improves neurological scores of subjects. This would indicate that neither therapies are effective.
      2. The tranplant alone did not improves neurological scores while transplant plus lithium significantly improves neurological scores compared to transplant alone and before transplant. This would strongly argue for a beneficial effect of lithium and CBMC transplants.
      3. Both the transplant + placebo and transplant + lithium differ from pre-injury and differ significantly from each other. This would suggest that CBMC has some beneficial effect and that CBMC plus lithium is more effective.


    What are some inclusion criteria for the trials?
    • Age 18-60. We are contemplating limiting the subjects to those between the ages of 18 to 60.
    • Chronic spinal cord injury. All will be people who have had stable neurological function for a year or more after injury. Stable means no change in ASIA category for 12 months.
    • Injury severity. We are planning to allow subjects who are ASIA (American Spinal Injury Asociation) category A, B, or C. This means that we will be accepting complete an dincomplete patients.
    • C5 to T10. We are planning to include all subjects with spinal cord injury at C5 through T10. Many of our hospitals cannot manage ventilator dependent patients and injury to T10 or lower may involve the lumbar enlargement and cauda equina.


    What are some exclusion criteria?
    • Age. Subjects that are <18 and >60 years of age will be excluded. Those under age 18 may not be able to give informed consent. Those over 60 may have increased complications from surgery due to age.
    • Neurological status. People who are still recovering substantially will not excluded from the trial because we will not be able to tell whether ithe treatment induced the recovery or this is the natural course of recovery.
    • Health. Any signficant medical condition (besides spinal cord injury) will be grounds for excluding the subject, including heart, lung, kidney, intestinal, hormonal, and other conditions that is not under adequate control.
    • Other trials. Subjects will be excluded if they are participating in another clinical trial. If they have participated in another clinical trial within the past year, they may be excluded.
    • Allergies. Subjects will be excluded if they have a history of allergy to lithium or commonly used antibiotics that will be part of the clinical trial.
    • Physician discretion. The investigator of the center has the descretion to exclude any subject for any reason.


    What are some risks of the trial?
    • Surgery. All the subjects will undergo surgery. The surgery will involve exposure of the spinal cord through two laminectomy (cutting the bone off the back of the spinal cord) just above and below the injury site. As with all surgeries, there will be small risk of damage to the spinal cord, infection, and other surgical complications.
    • Transplant. Four injections of HLA-matched cord mononucelar cells will be made above and below the injury site, at the dorsal root entry zones. This approach deliberately avoids exposing the injury site itself where the anatomy may be complicated and adhesions are present. The routes of injection also avoids injury to any of the matter tracts. Because the injections are made under direct visual control, blood vessels can be avoided.
    • Tumors. The likelihood of tumors forming from cord blood mononuclear cells is very low. HLA-matched cord blood cell transplants have been done in many thousands of people for over 20 years. These cells will not be manipulated or exposed in any way before transplantation. Animal studies indicate that they are very well behaved in the spinal cord and respect the bondaries of the spinal cord, as well as gray and white matter.
    • Lithium toxicity. The safety profile of lithium is well-known. At serum levels of 1 mM or less, lithium has relatively little or no toxic side effects. However, at serum levels above 1.5-2.0 mM that is maintained for long periods, people may experience nausea, vomiting, and other symptoms of lithium toxicity. Care will be taken to titrate the doses and to monitor serum lithium levels in the trial. In case of accidental overdoses, dialysis will be carried out.
    • Neuropathic pain. We are uncertain what lithium will do for neuropathic pain. Because lithium is known to increase neurotrophic factors which may stimulate axonal growth and sprouting, there is a possibility that it may increase neuropathic pain. We will be looking for increases in pain in the phase 1 trial. It is possible that if lithium does cause severe neuropathic pain, the treatment will be discontinued.
    • Drug interactions. Lithium may interact with certain drugs, particularly those that have affects of the kidney, including blood pressure and other medications. This is because lithium is cleared primarily through the urine and any drug that changes renal clearance of ions may affect lithium levels.


    I am sure that there may be other questions but people can ask and I can answer.

    Wise.
    Last edited by Wise Young; 03-30-2007 at 06:47 PM.

  2. #2
    Banned adi chicago's Avatar
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    if i had oeg procedure done by dr.huang july 2006 i still can have a new procedure done in the proximate future without any complications?
    thank you.
    Last edited by adi chicago; 03-30-2007 at 07:06 PM.
    • Dum spiro, spero.
      • Translation: "As long as I breathe, I hope."

  3. #3
    Quote Originally Posted by adi chicago
    if i had oeg procedure done by dr.huang july 2006 i still can have a new procedure done in the proximate future without any complications?
    thank you.
    I have proposed to the group that we allow all people who have not been part of an active clinical trial protocol elsewhere for one year to be part of our trial. Note that this is rather controversial. Some investigators don't want to have subject who may have received another therapy. I personally think that it shouldn't make that much difference as long as the subject still has room for recovery (i.e. is not an ASIA D or E) and has been stable neurological function for at least a year.

    Please note, however, that the surgeon does have discretion to turn down a patient for any reason. The reason is that the surgeon has to judge the risk of surgery and care. If the surgeon thinks that there is risk in doing the surgery and is not comfortable with doing so, I want to encourage the surgeon to exclude the subject from the study. So, for example, if the surgeon thinks that he will have a hard time getting to the spinal cord because of your previous surgery, he/she may exclude you. However, I think that this is unlikely.

    I also want to point out that while some of the centers have facilities for overseas patients, many do not. As the time for the trial gets closer, I will poll the centers concerning their willingness to take overseas subjects. We are also working on an arrangement with a major hospital in Beijing to provide such services but there is a lot to do yet before I can talk about this.

    Wise.

  4. #4
    Banned adi chicago's Avatar
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    thank you dr.wise .i will wait and i will never give up until sci will be history.
    sometimes i am so anxious regarding a new procedure and a 100%cure.
    god bless you ...do your job ...i will do mine[to stay alive and never give up].
    i hope we will meet one day.
    • Dum spiro, spero.
      • Translation: "As long as I breathe, I hope."

  5. #5
    Neuropathic pain. We are uncertain what lithium will do for neuropathic pain. Because lithium is known to increase neurotrophic factors which may stimulate axonal growth and sprouting, there is a possibility that it may increase neuropathic pain. We will be looking for increases in pain in the phase 1 trial. It is possible that if lithium does cause severe neuropathic pain, the treatment will be discontinued.
    Hi Dr. Young,

    To better assess this risk, will subjects with neuropathic pain be included to determine if lithium exacerbates their pain?
    Last edited by antiquity; 04-01-2007 at 11:18 AM.

  6. #6
    Dr. Young,
    I am new here and am just trying like veryone else to find that "cure" that will work for my husband. My "cure" was a miracle by the grace of God, my husbands just has not shown up yet. What would be the expected costs of this on the patient? Also, How long post injury must he be?

    I know I am SO Naive, and SO impatient, but if it worked on lab rats and other little experiments, why is it so difficult to get to work on humans? We need this so bad.

    Thank you for your time and work!
    Jenny--6 year post recovered SCI C-6, C-7
    --10 month post husband still recovering C-5, C-6

  7. #7
    Hi, Dr. Wise i don't clear about inclusive criteria you post due to i have a limitation of understanding english.

    C5 to T10. We are planning to include all subjects with spinal cord injury at C5 through T10. Many of our hospitals cannot manage ventilator dependent patients and injury to T10 or lower may involve the lumbar enlargement and cauda equina.

    i'm T11-12 sci so i suspected i can join with this clinical trial or not. if not. In the future if this testing is successful, in practice i can get treatment by this ways or not. please tell me , Thank you.

  8. #8
    Quote Originally Posted by npsychopedia
    Hi, Dr. Wise i don't clear about inclusive criteria you post due to i have a limitation of understanding english.

    C5 to T10. We are planning to include all subjects with spinal cord injury at C5 through T10. Many of our hospitals cannot manage ventilator dependent patients and injury to T10 or lower may involve the lumbar enlargement and cauda equina.

    i'm T11-12 sci so i suspected i can join with this clinical trial or not. if not. In the future if this testing is successful, in practice i can get treatment by this ways or not. please tell me , Thank you.
    npsychopedia, at least in the upcoming clinical trial (cord blood mononuclear cell ± lithium), we will not be accepting patients that are T11-T12. However, if the trial shows successful results, I believe it can and will be tried on people with T11-12.

    Wise.

  9. #9
    Quote Originally Posted by 99ss00ws6
    Dr. Young,
    I am new here and am just trying like veryone else to find that "cure" that will work for my husband. My "cure" was a miracle by the grace of God, my husbands just has not shown up yet. What would be the expected costs of this on the patient? Also, How long post injury must he be?

    I know I am SO Naive, and SO impatient, but if it worked on lab rats and other little experiments, why is it so difficult to get to work on humans? We need this so bad.

    Thank you for your time and work!
    Jenny--6 year post recovered SCI C-6, C-7
    --10 month post husband still recovering C-5, C-6

    Jenny,

    Both of the therapies that we are testing in ChinaSCINet should be reasonably inexpensive and available around the world. At the present, most umbilical cord blood sources are providing units of HLA-matched cord blood at about $22,000 each. The cost of lithium should be trivial, perhaps $20. There is the cost of surgery, of course, possibly less than $10,000. If our trial is successful and the results are accepted in the United States (and confirmed by a clinical trial in the United States), it should be covered by insurance as well. Thus, I believe that the costs should be low and eventually covered by insurance.

    Wise.

  10. #10
    Quote Originally Posted by antiquity
    Hi Dr. Young,

    To better assess this risk, will subjects with neuropathic pain be included to determine if lithium exacerbates their pain?
    We are not excluding patients with neuropathic pain. Wise.

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