Announcement

Collapse
No announcement yet.

Clinical Trial in the U.S

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

    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
    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.

    Comment


      #3
      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.

      Comment


        #4
        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; 4 Aug 2010, 7:41 PM.

        Comment


          #5
          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.

          Comment


            #6
            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.

            Comment


              #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

              Comment


                #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.

                Comment


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

                  Comment


                    #10
                    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

                    Comment


                      #11
                      Originally posted by Eric.S View Post
                      Tim, can you post links to all of the video's and websites you found that didn't look cousher?
                      Eric,

                      The following website will give you all the TCA videos and the sales gimmicks.

                      http://www.google.com/#q=TCA+stem+ce...59259b54139ad5

                      Comment


                        #12
                        Bugger that's disapointing
                        Not at all. Mr. Cratchit is mistaken. This trial is utilizing autologous cells, consequently the FDA has no legal jurisdiction to intervene into their application. It is possible to conduct a clinical trial and at the same time charge for application of these cells. If you do not meet the inclusion criteria, you pay. If you meet the inclusion criteria and are accepted into an FDA approved trial, you do not pay.

                        I am not endorsing in any way what this firm is doing, however, they are not at this point doing anything illegal.

                        Comment


                          #13
                          Originally posted by Schmeky View Post
                          Not at all. Mr. Cratchit is mistaken. This trial is utilizing autologous cells, consequently the FDA has no legal jurisdiction to intervene into their application. It is possible to conduct a clinical trial and at the same time charge for application of these cells. If you do not meet the inclusion criteria, you pay. If you meet the inclusion criteria and are accepted into an FDA approved trial, you do not pay.

                          I am not endorsing in any way what this firm is doing, however, they are not at this point doing anything illegal.
                          I never said that this company is illegal. I said that they are profiteers, making money on the side from patients, without being able to provide any results. Twenty thousand dollars is a lot to pay out to be a guinea pig. You may as well hand your money over to William Rader of Medra.
                          Furthermore, from what the sales rep told me, they already had met their quotient of patients for the study.

                          You really need to watch the TCA infomercials to see that this company is in business to make big bucks. They are a Beike and Excel

                          One of the first ISSCR warning guidelines is if the stem cell site provides patient testimonials, BEWARE. Testimonials are the worst kind of evidence and the cheesiest of advertizing. As Doctor Young has said on a number of occassions, beware of a clinical procedure that costs you as much as a car.
                          Furthermore, this company was inititated and has been involved with treating coronary patients. Who knows how many have improved? Have they published their findings, success rates? They have just embarked on treating ALS and SCI patients. They have absolutely no data to provide regarding treating these patients.

                          Comment


                            #14
                            Tim and Schemky, the testimonials are a clear evidence of fraud or umproven therapy. this is why we need to follow Geron's acute trials and Wise's chronics trials. If we can put these frauds to sleep with ratioal and scientific evidence that is published and accepted, they will go away.

                            keeping on

                            Comment


                              #15
                              But how does that discredit there trials? Maybe if more companies supplemented there research that way we'd get more trials... If they believe there procedure works enough to commit it to trial why not help supplement the costs with pay procedures? This is something I have always personally thought was a good idea.. I'm actually glad to see someone implementing it..

                              Comment

                              Working...
                              X