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Thread: Clinical Trial in the U.S

  1. #1
    Junior Member Mr. Willie's Avatar
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    Clinical Trial in the U.S

    Does anyone know much about bone-marrow Derived Mesenchymal Stem Cells.

    http://www.clinicaltrials.gov/ct2/sh...m+cells&rank=1

  2. #2
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    This is close to Schmeky, he might know some more. Some discussions in this thread as well about the study, check post #370-371.


    Inclusion Criteria:
    • Spinal cord injury within 60 months of screening
    This must mean to be defined for chronics too.

    Thanks for posting.

  3. #3
    Junior Member Mr. Willie's Avatar
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    No problem I'm sure a bunch of us would be interested in this post. We chronics need a boost. I am thinking hard about being a subject in this trial, but first I have to get some information from Dr. Gabriel P. Lasala who is conducting the trial. Then I will get Dr. Wise input on the Trial and also MSC's.

  4. #4
    Senior Member Schmeky's Avatar
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    Mr. Willie,

    This is about 3 hours from my home. My only concern is the cells are being administered intrathecally (spinal fluid), not intraspinally (directly into the cord). However, I would assume pre-clinical data supports intrathecal injection.

    I have not contacted this group; I would be interested in the lab results.


    Addendum: I sent an e-mail requesting inclusion criteria; I have volunteered at this point.
    Last edited by Schmeky; 08-04-2010 at 07:41 PM.

  5. #5
    Quote Originally Posted by Schmeky View Post
    Mr. Willie,

    This is about 3 hours from my home. My only concern is the cells are being administered intrathecally (spinal fluid), not intraspinally (directly into the cord). However, I would assume pre-clinical data supports intrathecal injection.

    I have not contacted this group; I would be interested in the lab results.


    Addendum: I sent an e-mail requesting inclusion criteria; I have volunteered at this point.
    Schmeky, this sounds a lot like what Xcell is doing. They also
    administer the cells intrathecally and I've read that there's no
    evidence to suggest that this method of aministering cells does
    anything to help chronic sci. So I guess if they are successful,
    they'd be the first one's to have an effective treatment
    administered intrathecally.

  6. #6
    Senior Member Schmeky's Avatar
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    Buck,

    I feel intrathecal administration is like doing something, without actually doing something.

    I think you're right. With the pace of getting things to trial, I feel I have little to loose.

  7. #7
    inclusion criteria


    Eligibility

    Ages Eligible for Study: 18 Years to 65 Years
    Genders Eligible for Study: Both
    Accepts Healthy Volunteers: No
    Criteria
    Inclusion Criteria:

    Age 18 to 65
    American Spinal Injury Association Impairment Scale A
    Clinical evidence of lesions located below c-spine 5 (C-5)
    Confirmation by MRI of injury level
    Time between injury and enrollment greater than 2 weeks
    Ability to provide informed consent
    Platelet count greater than 100 Thousand/uL at screening
    INR equal to or less than 1.5
    Hematocrit less than 30% prior to bone marrow aspiration
    Spinal cord injury within 60 months of screening
    Exclusion Criteria:

    Anoxic brain injury
    Inability to provide consent
    Sepsis
    Neurological deficits attributed to lesions above C-5
    Cerebro-vascular accidents with intracranial hemorrhage, acute brain injuries, meningitis, hydrocephalus or other potential diseases where the pressure in the cerebro spinal fluid is increased
    Multiple sclerosis
    Amyotrophic lateral sclerosis
    Cerebral Palsy
    Evidence of cancer over the last 3 years prior to enrollment
    Immunosuppressive diseases
    Platelet count lower than 100,000
    White blood count greater than 15,000 unless the patient is on steroids
    Bleeding disorders
    Clinical or laboratory evidence of meningitis
    Skin infection at the infusion site
    Pregnant or planning to become pregnant
    Contacts and Locations
    Please refer to this study by its ClinicalTrials.gov identifier: NCT01162915

  8. #8
    I contacted TCA for more info on the spinal cord clinical trial they are conducting. After reading the criteria for the study, I thought I was a perfect candidate. I am a C-6 C-7 incomplete with post injury of 4 years. However, I was told that the study was only accepting complete spinal cord injuries. This requirement is NOT stated in their eligibility requirements. I'm sure that , if I told them I was a complete, they would tell me they were only accepting incompletes?

    Anyway, once I was told that I was ineligible, the obvious sales rep offered me the bone marrow stem cell procedure for $20,000. Red flags were blazing. The clinical trial may be legit, but it is apparent that it is also a front for profiteering. Since, their clinical trial is at it's infant stage and being conducted for the sole purpose of safety and not efficacy, the $20,000 charge is being used to fund their clinical trials .The paying patient, is just a guinea pig, footing their research. If it so happens, that the patient has improvement, then that will just put icing on the cake. In other words, the patient is the scapegoat and TCA has nothing to lose.

    TCA is headed by a Dr. Lasalla, who is a Coronary Interventionist, whatever that means, and ihe is involved in conducting ALS, Spinal Cord and Coronary clinical trials. Too much on the menu, if you ask me. The company has a number of internet videos to advertize their procedure and videos of patient testimonials. Also, they have a full time staff member that petitions the FDA.

    All of these factors combined makes this company not as kosher as they lead one to believe. In light of these facts, it is evident that profit is their main goal and the FDA approved clinical trials are a sideline to legitimize their procedure, which at present has not been proven to have any beneficial results whatsover.

  9. #9
    Tim, can you post links to all of the video's and websites you found that didn't look cousher?

  10. #10
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    Quote Originally Posted by Tim Cratchit View Post
    I contacted TCA for more info on the spinal cord clinical trial they are conducting. After reading the criteria for the study, I thought I was a perfect candidate. I am a C-6 C-7 incomplete with post injury of 4 years. However, I was told that the study was only accepting complete spinal cord injuries. This requirement is NOT stated in their eligibility requirements. I'm sure that , if I told them I was a complete, they would tell me they were only accepting incompletes?

    Anyway, once I was told that I was ineligible, the obvious sales rep offered me the bone marrow stem cell procedure for $20,000. Red flags were blazing. The clinical trial may be legit, but it is apparent that it is also a front for profiteering. Since, their clinical trial is at it's infant stage and being conducted for the sole purpose of safety and not efficacy, the $20,000 charge is being used to fund their clinical trials .The paying patient, is just a guinea pig, footing their research. If it so happens, that the patient has improvement, then that will just put icing on the cake. In other words, the patient is the scapegoat and TCA has nothing to lose.

    TCA is headed by a Dr. Lasalla, who is a Coronary Interventionist, whatever that means, and ihe is involved in conducting ALS, Spinal Cord and Coronary clinical trials. Too much on the menu, if you ask me. The company has a number of internet videos to advertize their procedure and videos of patient testimonials. Also, they have a full time staff member that petitions the FDA.

    All of these factors combined makes this company not as kosher as they lead one to believe. In light of these facts, it is evident that profit is their main goal and the FDA approved clinical trials are a sideline to legitimize their procedure, which at present has not been proven to have any beneficial results whatsover.
    Bugger that's disapointing

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