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Advise Please!!

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    Advise Please!!

    Hello, I am a Physical Therapist Assistant,I am trying to start a SCI program where I work. Can any of you who have gone through a program such as this give me tips or pointers. Something that maybe really helped you, or maybe something that was ignored but needed to be addressed. I alse have a C4 complete patient if any of you have any advice I can do to help her, again something that could be overlooked by the AB population.

    Thanks, Cookie


    1st. get your c4 pt. directed to this sight it is by far the best thing that will help them with their SCI

    2. don't give them limitation on what they can do, never tell them NO


    4. GIVE THEM HOPE, today SCI cannot be curried but in the not to distant future it will be, DO NOT!!!!, DO NOT!!!! Just work on getting comfortable in your new life and excepting SCI .


    6. get them standing in a standing frame it helps with the attitude and keeping/maintaning bone mass

    7. Show them this chart from DR. YOUNG tell them to learn all they can about what's on it and to ask their doctor question about what's on it and you yourself should get familiar with the things on this chart so you know what's going on

    Earliest Time Frame of Potential SCI Therapies

    Wise Young, Ph.D., M.D.
    W. M. Keck Center for Collaborative Neuroscience
    Rutgers University, Piscataway, New Jersey,
    Many people have been asking about potential time frames of therapies that are under development for spinal cord injury.  There are too many unknowns to predict when therapies will be available.  However, it is possible to estimate what the minimum time requirements are for treatments that are currently under development, assuming that all goes well.  If there are any problems, of course, the development will be slowed down substantially or stopped.
    Let me first define some terms for people who might not be familiar with clinical trials.  Phase 1 refers to clinical trials that are primarily concerned with demonstrating safety and feasibility.  Such trials often do not have controls and are not sufficiently powered (i.e. have enough subjects) to demonstrate efficacy.  Phase 2 refers to clinical trials that are optimizing therapies, looking for efficacy.  If the trial is sufficiently powered to show efficacy, they are called Phase 2b.  Phase 3 trials are "pivotal trials" intended to demonstrate efficacy of an optimized therapy.
    Several assumptions were made in the following analyses.  First, all goes well in the trials, i.e. the trials don't run into any trouble in terms of safety and all the trials show positive results.  Second, adequate financial resources are available for preclinical and clinical studies.  Many treatments may fall out of the following list.  Nevertheless, with sufficient therapeutic options available for trial, one or more the therapies should show significant benefit with acceptable risk.  The rate-limiting step is funding and not therapeutic options.

    Earliest Possible Times for Pivotal Results


    Subacute SCI

    Chronic SCI

    Treadmill training

    Fampridine SR
    Lokomat & other devices

    Lumbar L2 stimulation
    Peripheral nerve bridge of SCI

    AC electrical current
    Activated macrophages
    AC electrical current
    Peripheral bridge to bladder

    Nogo receptor blockers
    Fetal human OEG
    Fetal human stem cells
    M1 antibody

    Porcine OEG
    Adult human OEG
    Adult human stem cells
    Adult neural stem cells

    Recombinant C3
    Therapeutic vaccine
    Therapeutic vaccine
    Cell transplant+AIT-082
    Cell transplant+Copaxone
    Cell transplant+inosine
    Cell transplant+neurotrophin
    Cell transplant+rolipram
    Cell transplant+Nogo blocker

    Recombinant C3
    Cell transplant+chondroitinase

    Cell transplant+ther vaccine
    Cell transplant+IN-1

    Cell transplant+C3

    Embryonic stem cells


    Brief description of therapies (potential mechanisms, company)

    •Â  Treadmill training (restoration of locomotion, many companies).  Several groups have shown that intensive treadmill training can restore locomotor function to 20-40% of patients with incomplete SCI.   Robotic devices (Lokomat, etc.) may be approved by next year.
    •Â  Fampridine SR (improve conduction in the spinal cord, Acorda).  Several phase 2 trials indicate that 4-AP can improve motor and sensory function in as many as 30% of people with chronic spinal cord injury.  A pivotal trial is underway with spasticity as the endpoint. 
    •Â  Peripheral nerve bridging to bladder (reinnervate bladder).  The approach to reinnervating the bladder is already being tried in China.  If phase 2 trials start in 2003, phase 3 in 2004-2005, pivotal results may be available in 2005.
    •Â  Peripheral nerve bridge of spinal cord injury site coupled with a growth cocktail (to stimulate regeneration, Cheng in Taiwan).  This approach is being carried out in Taiwan by Henreich Cheng.  He has already done over 50 patients in combined phase 1 and phase 2.  A pivotal phase 3 may be planned for 2003-2004. 
    •Â  AC electrical currents (stimulate regeneration, Purdue or Traxon).  Phase 1 trials have started for subacute spinal cord injury at Purdue and chronic spinal cord injury in Dublin (Traxon).  Phase 2 trials in 2003 and possibly pivotal results by 2004.
    •Â  Lumbar L2 stimulation (activate locomotor center and accelerates locomotor training, possibly Medtronics).  Two groups have conducted phase 2 trials showing that L2 lumbar stimulation accelerates locomotor recovery.  If phase 3 trials start in next year, we should have pivotal results by 2004. 
    •Â  Activated macrophages (growth factors delivery, Proneuron).  Phase 1 trials are now being done.  Phase 2 trials in 2003.  Phase 3 in 2004-2005.  Pivotal results in 2005 but only for subacute spinal cord injury.  So far, Proneuron does not have plans for using activated macrophages for chronic SCI.
    •Â  AIT-082 (stimulates axonal growth and stem cell proliferation).  Phase 2 trials by Neotherapeutics are underway.  Results should be available by 2003 and phase 3 trials (if the company gets funding) may start in 2003 and pivotal results may be available by 2004 but only for subacute SCI.
    •Â  Inosine (stimulates axonal growth and sprouting, Boston Life Science Inc).  Preclinical trials are being done now.  Recent safety studies have been completed.  Assuming phase 1 studies start in 2001, phase 2 studies in 2002, and phase 3 in 2003-2004, pivotal results may be available by 2005.
    •Â  Copaxone (stimulates antibodies to myelin-basic protein and lymphocytes).  Preclinical trials indicate beneficial effects on subacute SCI.  Because this drug is already approved for MS, this can go directly to phase 2 in 2003, possibly phase 3 in 2004-2005 with pivotal results by 2005.
    •Â  Rolipram (phosphodiesterase 4 blocker stimulate regeneration, Filbin).  Preclinical trials are underway.  Rolipram is already being tested in phase 2 trial for MS.  If Rolipram goes to phase 2 in spinal cord injury in 2004, phase 3 in 2005-2006, pivotal results may be available by 2006.
    •Â  Nogo receptor blockers (stimulates axonal regeneration and sprouting, Biogen).  Preclinical trials just reported.  If confirmed, phase 1 trials perhaps by 2003, phase 2 trials in 2004, phase 3 trials in 2005-6, we may get pivotal results by 2006.
    •Â  Fetal stem cells (stimulates regeneration and sprouting).  Phase 1 trials alrady completed in Russia and underway in China.  If this goes into phase 2 by 2003 in China and phase 3 in 2004-2005 in the U.S., we may get pivotal rsults by 2006.
    •Â  Fetal olfactory ensheathing glia (stimulates regeneration and sprouting).  Phase 1 trials already completed in Russia and underway in China.  If this goes into phase 2 by 2003, phase 3 in 2004-2005, we may get pivotal results by 2006.
    •Â  M1 antibody therapy (enhances remyelination of the spinal cord).  Preclinical trials are largely completed.  A phase 1 trial is planned for 2003, phase 2 in 2004, and phase 3 in 2005-6, with pivotal results in 2006.  
    •Â  Porcine olfactory ensheathing glia (stimulates regeneration and sprouting, Alexion).  Preclinical trials completed.  If this goes into phase 1 trials in 2003, phase 2 trials in 2004, phase 3 trials 2005-2006, we may get pivotal results by 2007. 
    •Â  Adult human olfactory ensheathing glia autografts (stimulates regeneration and sprouting).  Preclinical trials completed.  If this goes into phase 1 in 2003, phase 2 in 2004, phase 3 in 2005-2006, we may get pivotal results by 2007.
    •Â  Adult bone marrow human stem cells (provide a bridge for axonal growth and remyelination).  Preclinical trials are continuing.  If this goes into phase 1 in 2003, phase 2 in 2004, phase 3 in 2005-2006, we may get pivotal results by 2007.
    •Â  Adult neural stem cells (provide a bridge for axonal growth and remyelination).  Preclinical trial are continuing.  Phase 1 trial has been proposed.  If phase 1 starts 2003, phase 2 in 2004, phase 3 in 2005-2006, we may get pivotal results by 2007.
    •Â  Chondroitinase (breaks down chondroitin-6-sulfate proteoglycans to allow axonal regeneration).  Preclinical results for subacute SCI in 2002.  If a company picks this up, phase 1 trials are possible in 2003, phase 2 in 2004, and pivotal results by 2006.  In preclinical results for chronci SCI in 2003, this may lead to phase 2 in 2004, and pivotal results by 2007.
    •Â  IN-1 (antibody that blocks Nogo to stimulate axonal regeneration and sprouting).  If preclinical studies completed in 2003, phase 1 probably will start in 2004, phase 2 in 2005, and phase 3 in 2006-2007 with possible pivotal results by 2008.
    •Â  Recombinant C3 toxin blockade of rho GTPase (enhances axonal growth in the presence of growth blockers, Bioaxone).  Preclinical studies suggest that this treatment will stimulate axonal regeneration.  These are continuing.  Phase 1 trials may begin by 2004, phase 2 in 2005, and phase 3 in 2006-2007, with pivotal results in 2008.  Pivotal results for chronic SCI may take a year or two longer, i.e. 2009.
    •Â  Therapeutic vaccine (produces antibodies and activate lymphocytes).  Preclinical studies suggest that myelin basic protein may have positive effects on subacute SCI.  Phase 1 trials may start in 2004, phase 2 in 2005, and phase 3 in 2006-2007 with pivotal results by 2008.
    •Â  Cell transplant + growth factors (bridge injury site and stimulate regeneration).   The cell transplants may be OEG, fetal stem cells, adult stem cells, etc.  Growth factors may include any of the treatments such as neurotrophins, rolipram, AIT-082, chondrotinase, etc. These combination therapies will probably start in 2007 once the cell transplant data comes in.  Pivotal data for combination cell transplant and growth factor trials may be available within 2 years after the growth factors have been shown to be effective.
    •Â  Embryonic stem cell therapies (replacement of neurons).  Preclinical studies suggest that embryonic stem cells can replace neurons in the spinal cord.  However, due to restrictions in funding and supply of embyronic stem cells by the U.S. government, I am assuming that phase 1 and 2 trials of embryonic stem cell therapies will not start until overseas studies show sufficiently positive results to force the government to relax their restrictions or the current administration changes policies in 2008.  In such a case, pivotal trial results may become available by 2012.




      I just want to say that X-Racer pretty much nailed it all. Although I would like to add that even if you do not see any improvement in your patient tell them that they are! ANY motivation is helpful at this stage and it is often overlooked. I remember asking my outpatient pt at the time that I wanted to try the standing frame and what were the benefits of its use. She went on to mention it helps with bowel(for gravity reasons) and a healthier bladder, weight bearing to keep your bones strong to help prevent Osteosporosis and I said "oh good I'd like to try that!" Needless to say she just rolled her eyes... [img]/forum/images/smilies/rolleyes.gif[/img]



        Is this an acute care program, outpatient program or a rehabilitation program, or all three? How many SCI patients do you see there (new injuries) in a year? While it is great to have a program, if you don't see enough patients you will not be able to maintain the expertise to be of benefit to them, and may want instead to have a good acute care program and outpatient program, but refer patients for inpatient rehab to a close-by SCI center.

        Who else wants this program? You will have to seek the support your colleagues and the hospital administration on this. SCI care is VERY expensive, and administration will not support this unless you can show they will make a profit (a sad but real aspect of health care today).

        One of the most important aspects of a SCI program needs to be it's foundation philosophy. True inclusion of the patient and family at the center of the team needs to be key, with the patient and family at the center of all decision making including the setting of goals.

        You need to have fully wheelchair accessible facilities for your program, and a strong peer counseling program is needed as well (but only for those who want to participate in this...with their consent). You also need all the appropriate equipment including partial weight bearing gait training, standing tables and frames, bracing orthotist services, all the different wheelchairs (either owned or immediately available from vendors),computerized interface pressure measurement and pool therapy. The CARF standards for SCI rehabilitation is a good place to start in designing a program:

        Keep in mind that you cannot do rehab with just PT and OT. You need SCI/rehab nurses, therapeutic recreation specialists, respiratory therapists, social workers, psychologists, vocational counselors and physicians as well, in addition to consultation by specialists such as speech pathologists, rehab engineers, and orthopedists and neurosurgeons who specialize in spine and spinal cord surgery.

        You need to decide if you will be including vent dependent patients or not, and if so, what provision you have for appropriate equipment and discharge to the community.

        In addition, your team should visit some highly regarded SCI centers in your region of the country and observe the team and rehabilitation process.

        Patient/family education must be strongly emphasized as well, and of course you need good SCI/rehabilitation nurses to do much of this!

        The SCI-Nurses are advanced practice nurses specializing in SCI/D care. They are available to answer questions, provide education, and make suggestions which you should always discuss with your physician/primary health care provider before implementing. Medical diagnosis is not provided, nor do the SCI-Nurses provide nursing or medical care through their responses on the CareCure forums.