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Thread: To Wait or Not to Wait: Overseas’ Stem Cell Treatments

  1. #51
    Faye, try laying paralyzed in that bed and see if 20% chance according to 75% of the researchers doesn't look a whole lot better than 0% chance according to 100% of the researchers. It's all they've got to give us.

    There is no way to know if my incomplete sci is due to MP. My MRI looked bad though. I'd a lot rather wonder if it was the MP that gave me all my return than curse the doctors for not giving it to me, and wondering if that was to blame for my lack of return.

    Vito, yes, she's banned under her real name, Faye. I don't know why they are messing around with her right now. Happily, I'm not a moderator and that's not my problem.

  2. #52
    Quote Originally Posted by betheny
    There is no way to know if my incomplete sci is due to MP. My MRI looked bad though. I'd a lot rather wonder if it was the MP that gave me all my return than curse the doctors for not giving it to me, and wondering if that was to blame for my lack of return.

    Not to get into the whole mp argument but I gotta say this sounds like the same reasoning used by people that received experimental procedures.

    not that I think mp doesn't work. I received it after my spine began to swell and wasn't a quad because of it. if it wasn't because of mp i could care less as long as it stoped the swelling im fine with whatever did it.

  3. #53
    Quote Originally Posted by Eric.S
    Not to get into the whole mp argument but I gotta say this sounds like the same reasoning used by people that received experimental procedures.
    how so? mp has been proven to cause no harm, unlike experimental procedures.

  4. #54
    Quote Originally Posted by cass
    how so? mp has been proven to cause no harm, unlike experimental procedures.
    I thought that methylprednisolone put the patient at greater risk of surgical wound infection, so it is not without adverse effect.
    Daniel

  5. #55
    Quote Originally Posted by cass
    how so? mp has been proven to cause no harm, unlike experimental procedures.
    granted..

    And for the record I have no issues with clinical trials testing for safety. I feel that it is important and necessary but in my mind beyond safety i feel its overly cumbersome. if the procedure or product is not effective let the medical professionals decide its worthiness.

    After safety is assured I don't see what concern the fda should have. as you can see by those questioning mp it doesn't seem to matter anyway because there seems to be skeptics of even fda approved procedures.

  6. #56
    Quote Originally Posted by Eric.S
    Not to get into the whole mp argument but I gotta say this sounds like the same reasoning used by people that received experimental procedures.

    not that I think mp doesn't work. I received it after my spine began to swell and wasn't a quad because of it. if it wasn't because of mp i could care less as long as it stoped the swelling im fine with whatever did it.
    When I got mp, I wouldn't call it experimental. It was stocked in the hospital ER. I knew about it because of an article in Reader's Digest LOL! I have plenty of friends that have gotten experimental therapies. I only wish they hadn't all been taken advantage of. I think it is lucky that no one has gotten paralyzed worse from the experiments.

  7. #57
    Quote Originally Posted by dan_nc
    I thought that methylprednisolone put the patient at greater risk of surgical wound infection, so it is not without adverse effect.
    Dan,

    NASCIS 2 showed that the incidence of wound infection in the methylprednisolone treated group was 7% compared to 3.5% in the control group. This was not statistically significant. It was also a complication that could be readily treated with antibiotics, did not pose a risk to the patient, and could be prevented if the patients were given prophylactic antibiotic.

    For many years after our study was published, even though we did not recommend this practice, many neurosurgeons used methylprednisolone to treat patients during surgery where the spinal cord was manipulated. They would give the patient a 30 mg/kg bolus of methylprednisolone at the time of surgery. If the patient woke up with increased neurological deficit, they would give 5.4 mg/kg/hour for 23 hours. Otherwise, they would stop the drug. Note that high dose methylprednisolone was used to treat SARS in China.

    When we were doing the trial, we were concerned with several possible complications from methylprednisolone. The first was asepetic necrosis of the femoral head or other joints. Long-term steroid use is known to cause this problem. In fact, patients in China that received methylprednisolone for 7-10 days or longer developed this complication and many had to get hip replacements. The second are gastric hemorrhage. The patients in our study were all treated with the H2 blocker cimetidine and there was no increased incidence of gastric or duodenal hemorrhage. Third, high dose steroids may cause some depression of memory and confabulation. While this may have occurred in some patients, it was not consistent and did not last longer than the period of steroid administration.

    In NASCIS 3, we did find a statistically significant increased incidence of severe pneumonia in the 48-hour course of methylprednisolone, although there was no difference in the incidence of overall pneumonia. Based on this observation, we recommended that the 48-hour course of the drug be used only when the treatment was delayed to 3-8 hours after injury. Because there was no difference in the neurological outcomes of patients that received the 24-hour and 48-hour course of methylprednisolone, we reocmmended that people those that could be treated from 0-3 hours after injury receive only the 24-hour course.

    Wise.

  8. #58
    Faye was banned and is unfortunately now appears to be returning as Jaycee, continuing to post false information and claims on this site. Jaycee is banned.

    Wise.

  9. #59
    Mike,

    I am not sure that I understand your confusion. Four double-blind randomized clinical trials had been carried out to assess methylprednisolone in spinal cord injury. In my opinion, the results were clearly positive and probably 90% of doctors in the United States and Canada use the drug for people with acute spinal cord injury for trauma. Because the trials did not address the question of gunshot induced spinal cord injury, there is no consensus concerning its use for such injuries. The two major trials were:
    • NASCIS 2. This trial compared the 24-hour course of methylprednisolone (MP) against placebo control. There were about 170 patient in the MP and placebo groups. Half of the patients were treated within 8 hours and half were treated between 8-24 hours. At 6 months, those patients that were treated within 8 hours recovered 21% of their motor score compared to 8% in the control if they were "complete" spinal cord injury. Incomplete patients recovered 75% of their motor score compared to 59% of the motor score when they were treated with 8 hours. Patients treated more than 8 hours after injury did not show any difference in motor or sensory improvement. The total average improvement of motor scores was about 20% greater in the MP treated group. Similar improvement differences were observed in the sensory scores. These results were maintained at 12 months after injury. There was no significant difference in complication rates between the two groups. The study recommended that people with acute spinal cord injury be treated as soon as possible after spinal cord injury with the 24-hour course of methylprednisolone. (Note that the study had a third treatment arm, naloxone. Patients treated with naloxone were in between those treated with placebo and those treated with MP.)
    • NASCIS 3. This trial compared the 24-hour course of MP with a 48-hour course of MP. There were again about 170 patients in the 24h MP and the 48h MP group. Half of the patients were treated within 3 hours and the other half were treated between 3-8 hours. At 6 months after injury, there was no difference in motor or sensory recovery between the two groups treated within 3 hours. However, in patients treated between 3-8 hours after injury, the 48h MP group had better recovery than the 24h MP group. The 48h MP group showed significantly greater incidence of severe pneumonia. The study recommended that 24-hour course of MP in all cases if the treatment can be initiated within 3 hours after injury. The 48-hour course of MP should be used if they were treated between 3-8 hours. Both studies recommended against the use of MP when it could not be started within 8 hours after injury. (Note that the study also included a treatment arm with an anti-oxidant tirilazad mesylate).

    In the late 1990's, several neurosurgeons in Canada concluded that they were not convinced by the data presented in the clinical trials (Hurlbert, 2001). There was one small 100-patient trial that had been carried out in France in the late 1990's, indicating no difference in the outcomes of patients that had been treated with placebo, MP, or nimodipine (a calcium channel blocker). Usually, when there is a conflict with clinical trial results, the way that such conflicts are resolved is by meta-analysis where all the results of the trials are pooled together. In 2002, Bracken did such an analysis for the Cochran Review (widely accepted as the most rigorous of the clinical trial data analysis journals) and showed that the methylprednisolone results were still statistically significant, even if the results of the French trial were incorporated into the analysis.

    Regarding Kevin Everett, doctors try to do there best for the patients. Evertee had been treated early with methylprednisolone, as he should have been. He was then operated on and they used hypothermia during the surgery to cool down his spinal cord. There are both animal and some human clinical trial data suggesting that hypothermia and methylprednisolone together are beneficial for spinal cord injury. However, to my knowledge, there has never been a study of hypothermia alone in patients.

    Please note that it is not clear whether Everett was ASIA A before his surgery. While there were several comments from his surgeon shortly after his surgery that his prognosis was bleak, I was not able to find any definitive statement concerning his ASIA classification before surgery. However, apparently, within a day after surgery, he began moving his legs. He was classified as a Central Cord Syndrome, a form of ASIA C incomplete. Note that ASIA C patients have a greater than 90% of recovering independent walking by 12 months after injury, according to a recent study by Dobkin, et al. (2006).

    It is not clear (at least to me) whether Everett's recovery was due to methylprednisolone, the hypothermia, or simply because he was incomplete to begin with before surgery. However, the fact that he was a central cord incomplete after surgery indicates that he has high likelihood of recovering walking, if he works hard at it. Generally, people with central cord syndromes recover their legs first and then eventually their arms as well. Remember Dennis Byrd? He was a defensive lineman for the New York Jets when he also did a spearing tackle. When he got to the hospital, he had only a little bit of touch sensation on one leg (I was told this by the neurosurgeon). He received methylprednisolone but no hypothermia. In any case, he walked out of the hospital on crutches about 6 weeks later (Source). Everett had early decompresson and methylprednisolone. Did hypothermia help? I don't know for sure but it probably did and I applaud its use. Miami Project has long been interested and studied the effects of hypothermia in stroke and spinal cord injury. For example, this year, Khan, et al. (2007) published paper suggesting that people with spinal cord injury sometimes get hypothermic and this may be beneficial for recovery. Many groups have used hypothermia to protect the spinal cord (Khoynezhad, et al, 2005).

    Finally, please, Christopher Reeve's spinal cord was not severed. There is no evidence that this is so. Note that Christopher recoverd substantial sensory function (over 75% of his body) by 2-3 years after injury. He also recovered ability to move is left index finger about 5 years after injury and ability to lift 5 lb weights with his legs in the swimming pool at 7 years after injury. Chrstiopher received methylprednisolone at 30 minutes after injury.

    Wise.

    Literature cited
    1. Hurlbert RJ (2001). The role of steroids in acute spinal cord injury: an evidence-based analysis. Spine. 26: S39-46. Department of Clinical Neurosciences, University of Calgary, Foothills Hospital, 1403 29th Street NW, Calgary, Alberta T2N 2T9, Canada. jhurlber@ucalgary.ca. STUDY DESIGN: Literature review. OBJECTIVES: The purpose of this article is to review the available literature and formulate evidence-based recommendations for the use of methylprednisone in the setting of acute spinal cord injury (SCI). SUMMARY OF BACKGROUND DATA: Since the early 1990s, methylprednisolone has become widely prescribed for the treatment of acute SCI. Arguably, it has become a standard of care. METHODS: Through an electronic database search strategy and by cross-reference with published literature, appropriate clinical studies were identified. They were reviewed in chronologic order with respect to study design, outcome measures, results, and conclusions. RESULTS: Nine studies were identified that attempted to evaluate the role of steroids in nonpenetrating (blunt) spinal cord injury. Five of these were Class I clinical trials, and four were Class II studies. All of the studies failed to demonstrate improvement because of steroid administration in any of the a priori hypotheses testing. Although post hoc analyses were interesting, they failed to demonstrate consistent significant treatment effects. CONCLUSIONS: From an evidence-based approach, methylprednisolone cannot be recommended for routine use in acute nonpenetrating SCI. Prolonged administration of high-dose steroids (48 hours) may be harmful to the patient. Until more evidence is forthcoming, methylprednisolone should be considered to have investigational (unproven) status only.
    2. Bracken MB (2002). Steroids for acute spinal cord injury (Cochrane Review). Cochrane Database Syst Rev. CD001046. Department of Epidemiology and Public Health, Yale School of Medicine, 60 College street, Box 20834, New Haven, Connecticut, USA, 06520-8034. brackenmb@maspo3.mas.yale.edu. BACKGROUND: Acute spinal cord injury is a devastating condition typically affecting young people with a preponderance being male. Steroid treatment in the early hours of the injury is aimed at reducing the extent of permanent paralysis during the rest of the patient's life. OBJECTIVES: To review randomized trials of steroids for acute spinal cord injury. SEARCH STRATEGY: The review draws on the search strategy developed by the Cochrane Injuries Group. In addition, files of the National Acute Spinal Cord Injury Study have been reviewed and a Medline search conducted. SELECTION CRITERIA: All published or unpublished randomized controlled trials of steroid treatment for acute spinal cord injury in any language. DATA COLLECTION AND ANALYSIS: Data have been abstracted from original trial reports. For the NASCIS, Japanese and French trials, additional data (e.g. SDs) have been obtained from the original authors. MAIN RESULTS: There are few trials in this area of medical care. Only one steroid has been extensively studied, methylprednisolone sodium succinate, which has been shown to improve neurologic outcome up to one year post injury if administered within eight hours of injury and in a dose regimen of: bolus 30mg/kg administered over 15 minutes with a maintenance infusion of 5.4 mg/kg per hour infused for 23 hours. The initial North American trial was replicated in a Japanese trial but not in the one from France. Data has been obtained from the latter studies to permit appropriate meta-analysis of all three trials. This analysis indicates significant recovery in motor function after methylprednisolone therapy when administration commences within eight hours of injury. A more recent trial indicates that if methylprednisolone therapy is given for an additional 24 hours (for a total of 48 hours), additional improvement in motor neurologic function and functional status is observed. This is particularly observed if treatment cannot be started until between three to eight hours after injury. The same methylprednisolone therapy has been found effective in whiplash injuries and a modified regimen found to improve recovery after surgery for lumbar disc disease. REVIEWER'S CONCLUSIONS: High dose methylprednisolone steroid therapy is the only pharmacological therapy shown to have efficacy in a Phase Three randomized trial when it can be administered within eight hours of injury. A recent trial indicates additional benefit by extending the maintenance dose from 24 to 48 hours if start of treatment must be delayed to between three and eight hours after injury. There is an urgent need for more randomized trials of pharmacological therapy for acute spinal cord injury.
    3. Dobkin B, Apple D, Barbeau H, Basso M, Behrman A, Deforge D, Ditunno J, Dudley G, Elashoff R, Fugate L, Harkema S, Saulino M and Scott M (2006). Weight-supported treadmill vs over-ground training for walking after acute incomplete SCI. Neurology. 66: 484-93. Department of Neurology, University of California Los Angeles, Neurologic Rehabilitation and Research Program, Reed Neurologic Research Center, Los Angeles, CA 90095, USA. bdobkin@mednet.ucla.edu. OBJECTIVE: To compare the efficacy of step training with body weight support on a treadmill (BWSTT) with over-ground practice to the efficacy of a defined over-ground mobility therapy (CONT) in patients with incomplete spinal cord injury (SCI) admitted for inpatient rehabilitation. METHODS: A total of 146 subjects from six regional centers within 8 weeks of SCI were entered in a single-blinded, multicenter, randomized clinical trial (MRCT). Subjects were graded on the American Spinal Injury Association Impairment Scale (ASIA) as B, C, or D with levels from C5 to L3 and had a Functional Independence Measure for locomotion (FIM-L) score < 4. They received 12 weeks of equal time of BWSTT or CONT. Primary outcomes were FIM-L for ASIA B and C subjects and walking speed for ASIA C and D subjects 6 months after SCI. RESULTS: No significant differences were found at entry between treatment groups or at 6 months for FIM-L (n = 108) or walking speed and distance (n = 72). In the upper motor neuron (UMN) subjects, 35% of ASIA B, 92% of ASIA C, and all ASIA D subjects walked independently. Velocities for UMN ASIA C and D subjects were not significantly different for BWSTT (1.1 +/- 0.6 m/s, n = 30) and CONT (1.1 +/- 0.7, n = 25) groups. CONCLUSIONS: The physical therapy strategies of body weight support on a treadmill and defined overground mobility therapy did not produce different outcomes. This finding was partly due to the unexpectedly high percentage of American Spinal Injury Association C subjects who achieved functional walking speeds, irrespective of treatment. The results provide new insight into disability after incomplete spinal cord injury and affirm the importance of the multicenter, randomized clinical trial to test rehabilitation strategies.
    4. Khan S, Plummer M, Martinez-Arizala A and Banovac K (2007). Hypothermia in patients with chronic spinal cord injury. J Spinal Cord Med. 30: 27-30. University of Miami School of Medicine, Miami, Florida 33136, USA. DESIGN: Retrospective analysis of medical records. BACKGROUND/OBJECTIVES: To determine frequency and degree of hypothermic episodes in patients with chronic spinal cord injury (SCI). SETTING: Veterans Administration Medical Center. METHODS: Research involved analysis of body temperature records of 50 chronic patients with tetraplegia. All patients were men with a length of injury of 19 +/- 6 years. Mean age was 53 +/- 15 (SD) years. Data were derived from the computerized patient record database system of the Veterans Administration Medical Center. Results were classified into 3 groups: (a) hypothermia (< 95 degrees F), (b) subnormal temperature (< 97.7 degrees F), and normal temperatures (97.7 degrees F to 98.4 degrees F). Body temperature was recorded during hospitalization (minimum duration of 30 days) using an oral probe twice a day. Ambient temperature was controlled by a central air-conditioning system and maintained at 72 degrees F to 74 degrees F. RESULTS: A total of 867 measurements of body temperature were evaluated; normal temperature was recorded 298 times (35%), subnormal temperature was recorded 544 times (63%), and hypothermia was recorded 25 times (3%). There were 15 patients with 30 hypothermic episodes; subnormal temperature was found in all 50 patients from 1 to 47 times. Regression analysis of age and duration of SCI showed a nonsignificant relationship with body temperature. CONCLUSIONS: Our data suggest that patients with tetraplegia after SCI have significant dysfunction of thermoregulation associated with frequent episodes of subnormal body temperature in a normal ambient environment. Further studies are needed to evaluate possible consequences of low temperatures on the general health of patients and to develop preventive interventions.
    5. Khoynezhad A, Bello R, Smego DR, Nwakanma L and Plestis KA (2005). Improved outcome after repair of descending and thoracoabdominal aortic aneurysms using modern adjuncts. Interact Cardiovasc Thorac Surg. 4: 574-6. Department of Cardiothoracic Surgery, Mount Sinai Medical Center, Mount Sinai School of Medicine, New York, NY, USA. akhoy@lycos.com. OBJECTIVES: To evaluate current strategies to decrease spinal cord and organ dysfunction in patients undergoing repair of descending and thoracoabdominal aneurysms. METHODS: We reviewed 94 consecutive cases of descending and thoracoabdominal aortic aneurysm repairs to determine the impact of modern adjuncts on postoperative neurologic deficit and mortality. The adjuncts used in these patients included perioperative cerebrospinal fluid drainage, distal aortic perfusion, reattachment of critical intercostal vessels, permissive hypothermia and hypothermic circulatory arrest with antegrade cerebral perfusion. Between December 1999 and March 2005, 24/94 (26%) patients were operated on for thoracoabdominal aortic aneurysm type I, seven (7%) for type II, 25/94 (27%) for type III or type IV, and 38/94 (40%) for descending thoracic aneurysms. Perioperative parameters were collected for all patients, and analyzed retrospectively. RESULTS: Twenty (21%) of the patients required hypothermic circulatory arrest for conduction of the operation. The postoperative rate of paraplegia was 3% (3/94). One patient developed temporary paraparesis. Overall operative mortality was 10% (9/94). This included 12/94 (13%) patients who underwent surgery emergently for ruptured or contained rupture of aortic aneurysm. CONCLUSION: Use of perioperative cerebrospinal fluid drainage, distal aortic perfusion and permissive hypothermia result in a low incidence of spinal cord injury and a low operative mortality.



    Wise.



    Quote Originally Posted by mike
    Frankly I am confused by this apparent hit or miss approach to dealing with therapies for spinal cord injuries. In the case of Everett, both methylprednisolone and the saline therapy were applied and because both therapies were use we don't realy know which helped his recovery. So what have we learned, probably nothing.

    My understanding of developing new therapies was that first you test them on animals and then if the results are good you move onto human trials. Why is it not possible to test the saline approach with animals so that one group get the methylprednisolone and the other gets the saline solution to see which works best? Obviously another issue to consider is the extent of the injury as a c2 injury can be merely a contusion or actually a severing of the cord which happened with Christopher Reeves. It seems that that test could be handled more effectively by first determing the extent of injury and the benefit of each of these drugs with animal experiments before going to humans. I fully understand that even after the animal experiments there are still questions as to side effects of the therapy that can only be fully tested in humans, but at least there should be some sort of manner of getting to that point.

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